ACADEMIC REGULATIONS & SYLLABUS Faculty of Pharmacy Bachelor of Pharmacy Programme CHAROTAR UNIVERSITY OF SCIENCE & TECHNOLOGY Education Campus – Changa, (ECC), hitherto a conglomerate of institutes of professional education in Engineering, Pharmacy, Computer Applications, Management, Applied Sciences, Physiotherapy and Nursing, is one of the choicest destinations by students. It has been transformed into Charotar University of Science and Technology (CHARUSAT) through an Act by Government of Gujarat. CHARUSAT is permitted to grant degrees under Section-22 of UGC- Govt. of India. The journey of CHARUSAT started in the year 2000, with only 240 Students, 4 Programmes, one Institute and an investment of about Rs. 3 Crores (INR 30 million). At present there are seven different institutes falling under ambit of six different faculties. The programmes offered by these faculties range from undergraduate (UG) to Ph.D degrees including M.Phil. These faculties, in all offer 23 different programmes. A quick glimpse in as under: Faculty Institute Faculty of Technology & Engineering Charotar Institute of Technology Faculty of Pharmacy Ramanbhai Patel College of Pharmacy Faculty of Management Studies Indukaka Ipcowala Institute of Management Faculty of Computer Applications Faculty of Applied Sciences Charotar Institute of Computer Applications P.D.Patel Institute of Applied Sciences Faculty of Medical Sciences Charotar Institute of Physiotherapy Charotar Institute of Nursing Programmes Offered B.Tech M.Tech Ph.D B.Pharm M.Pharm Ph.D M.B.A PGDBM Ph.D M.C.A Ph.D M.Sc M.Phil Ph.D B.PT B.Sc (Nursing) The development and growth of the institutes have already led to an investment of over Rs.63 crores (INR 630 Million). The future outlay is planned with an estimate of Rs. 250 Crores (INR 2500 Million). © CHARUSAT 2012 Page 2 of 240 The University is characterized by state-of-the-art infrastructural facilities, innovative teaching methods and highly learned faculty members. The University Campus sprawls over 100 acres of land and is Wi-Fi enabled. It is also recognized as the Greenest Campus of Gujarat. CHARUSAT is privileged to have 300 core faculty members, educated and trained in Stanford, IITs, IIMs and leading Indian Universities, and with long exposure to industry. It is also proud of its past students who are employed in prestigious national and multinational corporations. From one college to the level of a forward-looking University, CHARUSAT has the vision of entering the club of premier Universities initially in the country and then globally. High Moral Values like Honesty, Integrity and Transparency which has been the foundation of ECC continue to anchor the functioning of CHARUSAT. Banking on the world class infrastructure and highly qualified and competent faculty, the University is expected to be catapulted into top 20 Universities in the coming five years. In order to align with the global requirements, the University has collaborated with internationally reputed organizations like Pennsylvania State University – USA, University at Alabama at Birmingham – USA, Northwick Park Institute –UK, ISRO, BARC, etc. CHARUSAT has designed curricula for all its programmes in line with the current international practices and emerging requirements. Industrial Visits, Study Tours, Expert Lectures and Interactive IT enabled Teaching Practice form an integral part of the unique CHARUSAT pedagogy. The programmes are credit-based and have continuous evaluation as an important feature. The pedagogy is student-centred, augurs well for self-learning and motivation for enquiry and research, and contains innumerable unique features like: • • • • • Participatory and interactive discussion-based classes. Sessions by visiting faculty members drawn from leading academic institutions and industry. Regular weekly seminars. Distinguished lecture series. Practical, field-based projects and assignments. © CHARUSAT 2012 Page 3 of 240 • • • • Summer training in leading organizations under faculty supervision in relevant programmes. Industrial tours and visits. Extensive use of technology for learning. Final Placement through campus interviews. Exploration in the field of knowledge through research and development and comprehensive industrial linkages will be a hallmark of the University, which will mould the students for global assignments through technology-based knowledge and critical skills. The evaluation of the student is based on grading system. A student has to pursue his/her programme with diligence for scoring a good Cumulative Grade Point Average (CGPA) and for succeeding in the chosen profession and life. CHARUSAT welcomes you for a Bright Future © CHARUSAT 2012 Page 4 of 240 CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY Faculty of Pharmacy ACADEMIC REGULATIONS Bachelor of Pharmacy (B. Pharm.) Programme Charotar University of Science and Technology (CHARUSAT) CHARUSAT Campus, At Post: Changa – 388421, Taluka: Petlad, District: Anand Phone: 02697-247500, Fax: 02697-247100, Email: info@charusat.ac.in www.charusat.ac.in Year - 2012 © CHARUSAT 2012 Page 5 of 240 CHARUSAT FACULTY OF PHARMACY ACADEMIC REGULATIONS Bachelor of Pharmacy (B. Pharm.) Programme To ensure uniform system of education, duration of undergraduate programmes, eligibility criteria for and mode of admission, credit load requirement and its distribution between courses and system of examination and other related aspects, following academic rules and regulations are recommended. 1. System of Education The Semester system of education should be followed across The Charotar University of Science and Technology (CHARUSAT) at Undergraduate levels. Each semester will be at least 90 working day duration. Every enrolled student will be required to take a specified load of course work in the chosen subject of specialization and also complete a project/dissertation if any. 2. Duration of Programme Undergraduate programme (B.Pharm) Minimum 8 semesters (4 academic years) Maximum 12 semesters (6 academic years) 3. Eligibility for admissions As decided from time to time by the Government of Gujarat and CHARUSAT 4. Mode of admissions As decided from time to time by the Government of Gujarat and CHARUSAT 5. Programme structure and Credits Please refer detailed syllabus 6. Attendance 6.1 All activities prescribed under these regulations and listed by the course faculty members in their respective course outlines are compulsory for all students pursuing the B. Pharm. Programme. No exemption will be given to any student from attendance except on account of serious personal illness or accident or family © CHARUSAT 2012 Page 6 of 240 calamity that may genuinely prevent a student from attending a particular session or a few sessions. However, such unexpected absence from classes and other activities will be required to be condoned by the Principal. 6.2 Student attendance in a course should be 80%. 7 Course Evaluation 7.1 The performance of every student in each course will be evaluated as follows: 7.1.1 Internal evaluation by the course faculty member (s) based on continuous assessment, for 20%* of the marks for the course; and 7.1.2 Final examination by the University through written paper or practical test or oral test or presentation by the student or a combination of any two or more of these, for 80%* of the marks for the course. *as per norms laid down by Pharmacy Council of India (PCI) 7.1.3 Theory and Practical component of the same course shall be considered as separate courses. 7.2 Internal Evaluation (Theory) Two Theory tests (each test of 20 marks and one hour duration) shall be conducted as per the schedule notified by the Institute for every course in a semester. For the award of the internal marks, the average of marks obtained in two tests shall be considered. 7.3 Internal evaluation (Practicals) The distribution of marks for calculating the internal marks in every course of practical shall be: Performance of the exercise Viva Quiz Record (Journal) Total Internal Marks (out of 20) 20 Marks (One test of three hours duration) 20 Marks (Two tests each of 10marks) 20 Marks (Two tests each of 10marks) 20 Marks 80 Marks (Marks obtained out of 80) / 4 7.4 University Examination 7.4.1. The final examination by the University for 80% of the evaluation for the course will be through written paper or practical test or oral test or presentation by the student or a combination of any two or more of these. 7.4.2. In order to earn the credit in a course a student has to obtain grade other than FF. 7.5 Performance at Examination 7.5.1 Minimum performance with respect to university examination as well as overall (university + internal) will be an important consideration for passing a course. © CHARUSAT 2012 Page 7 of 240 Details of minimum percentage of marks to be obtained in the examinations is as follows Minimum marks in Minimum marks University Exam per Overall per course course 40% 45% 7.5.2 If a candidate obtains minimum required marks per course in university examination but fails to obtain minimum required overall marks, he/she has to repeat the university examination till the minimum required overall marks are obtained.(As per the clause 7.5.1) 8 Grading 8.1 The total of the internal evaluation marks and final University examination marks in each course will be converted to a letter grade as well as to a ten-point scale as per the following scheme: Table: Grading Scheme (UG) Range of Marks (%) ≥80 <80 ≥73 <73 ≥66 <66 ≥60 <60 ≥55 <55 ≥50 <50 ≥45 <45 Corresponding Letter Grade Numerical point (Grade Point) corresponding to the letter grade AA AB BB BC CC CD DD FF 10 9 8 7 6 5 4 0 8.2 The student’s performance in any semester will be assessed by the Semester Grade Point Average (SGPA). Similarly, his/her performance at the end of two or more consecutive semesters will be denoted by the Cumulative Grade Point Average (CGPA). The SGPA and CGPA are calculated as follows: (i) (ii) (iii) (iv) (v) SGPA ∑ Ci Gi / ∑ Ci where Ci is the number of credits of course i Gi is the Grade Point for the course i and i = 1 to n, n = number of courses in the semester CGPA = ∑ Ci Gi / ∑ Ci where Ci is the number of credits of course i Gi is the Grade Point for the course i and i = 1 to n, n = number of courses of all semesters up to which CGPA is computed. No student will be allowed to move further if CGPA is less than 3 at the end of every academic year. A student will not be allowed to move to third year if he/she has not cleared all the courses of first year. A student will not be allowed to move to fourth year if he/she has not cleared all the courses of second year. © CHARUSAT 2012 = Page 8 of 240 9. Award of Degree 9.1 Every student of the programme who fulfils the following criteria will be eligible for the award of the degree: 9.1.1 He/She should have earned at least minimum required credits as prescribed in course structure; and 9.1.2 He/She should have cleared external and overall evaluation components in every course; and 9.1.3 He/She should have secured a minimum CGPA of 5.0 at the end of the programme; 9.1.4 In addition to above, the student has to complete the required formalities as per the regulatory bodies, if any. 9.1.5 The candidate has to undergo Industrial Training in any of the approved pharmaceutical manufacturing plant/laboratory, for 15 weeks during vacation due at the end of 6th semester B.Pharm. and at the end of 8th semester B.Pharm. 9.2 The student who fails to satisfy minimum requirement of CGPA will be allowed to improve the grades so as to secure a minimum CGPA for award of degree. Only latest grade will be considered. 10 Award of Class The class awarded to a student in the programme is decided by the final CGPA as per the following scheme: Distinction: First class: Second Class: 11 CGPA ≥ 7.5 CGPA ≥ 6.0 & < 7.5 CGPA ≥ 5.0 & < 6.0 Transcript The transcript issued to the student at the time of leaving the University will contain a consolidated record of all the courses taken, credits earned, grades obtained, SGPA,CGPA, class obtained, etc. © CHARUSAT 2012 Page 9 of 240 CHAROTAR UNIVERSITY OF SCIENCE & TECHNOLOGY BACHELOR OF PHARMACY (B. Pharm.) PROGRAMME SEMESTER 1 SCHEME OF TEACHING Contact hours per week Theory Practical 3 -3 3 Course Code PH101 PH102 PH103 PH104 CE105 MA131 EN103 PH105 * Name Human Anatomy & Physiology-I Basic Pharmacognosy-I Pharmaceutical Chemistry-I 3 3 (Inorganic) Pharmaceutical Engineering-I 3 3 Basic Computer Applications 2 3 Basic Mathematics 3 -Communication Skills-I 1 3 -3 Project-I* Total 18 18 Total credits of 1st semester: 27 Credits Theory 3 3 Practical -1.5 Total 3 4.5 3 1.5 4.5 3 2 3 1 -18 1.5 1.5 -1.5 1.5 9 4.5 3.5 3 2.5 1.5 27 Herbarium to be prepared under the guidance of the faculty. SCHEME OF EVALUATION Course Code PH101 PH102 PH103 PH104 CE105 MA131 EN103 PH105 Name Human Anatomy & Physiology-I Basic Pharmacognosy-I Pharmaceutical Chemistry-I (Inorganic) Pharmaceutical Engineering-I Basic Computer Applications Basic Mathematics Communication Skills-I Project-I Total © CHARUSAT 2012 Marks Theory Practical University Institute University Institute Level Level Level Level Evaluation Evaluation Evaluation Evaluation 80 20 --80 20 80 20 80 80 80 80 80 -- 20 20 20 20 20 -140 560 Total marks of 1st semester: 1200 80 20 80 80 -40 -360 20 20 -10 50 140 Page 10 of 240 CHAROTAR UNIVERSITY OF SCIENCE & TECHNOLOGY BACHELOR OF PHARMACY (B. Pharm.) PROGRAMME SEMESTER 2 SCHEME OF TEACHING Code PH106 PH107 PH108 PH109 PH110 MA141 EN104 PH111 Course Name Human Anatomy & Physiology-II Basic Pharmacognosy-II Pharmaceutical Chemistry - II (Physical) Pharmaceutical Engineering – II Dispensing Pharmacy Advanced Mathematics Communication Skills-II Engineering graphics Total Contact hours per week Theory Practical 3 3 3 3 Credits Theory 3 3 Practical 1.5 1.5 Total 4.5 4.5 2 -- 2 -- 2 3 3 3 1 -18 3 3 -3 3 18 3 3 3 1 -18 1.5 1.5 -1.5 1.5 9 4.5 4.5 3 2.5 1.5 27 Total credits of 2nd semester: 27 SCHEME OF EVALUATION Marks Course Code PH106 PH107 PH108 PH109 PH110 MA141 EN104 PH111 Name Theory University Institute Level Level Evaluation Evaluation 80 20 80 20 Human Anatomy & Physiology-II Basic Pharmacognosy-II Pharmaceutical Chemistry - II 80 20 (Physical) Pharmaceutical Engineering -II 80 20 Dispensing Pharmacy 80 20 Advanced Mathematics 80 20 Communication Skills-II 80 20 Engineering graphics --Total 560 140 Total marks of 2nd semester: 1250 © CHARUSAT 2012 Practical University Institute Level Level Evaluation Evaluation 80 20 80 20 -- -- 80 80 -40 80 440 20 20 -10 20 110 Page 11 of 240 CHAROTAR UNIVERSITY OF SCIENCE & TECHNOLOGY BACHELOR OF PHARMACY (B. Pharm.) PROGRAMME SEMESTER 3 SCHEME OF TEACHING Course Code PH201 PH202 PH203 PH204 PH205 PH206 MB220 PH207 Contact hours per week Theory Practical 3 -3 3 Course Name Pathophysiology Pharmacognosy & Phytochemistry-I Organic Chemistry-I Pharmaceutical Analysis-I Pharmaceutical Engineering-III Pharmaceutical Jurisprudence Life Management Skills Seminar-I Total Theory 3 3 Credits Practical -1.5 Total 3 4.5 3 3 3 3 3 3 1.5 1.5 4.5 4.5 3 3 3 1.5 4.5 3 -- 3 -- 3 -- 3 -- 1.5 1.5 -18 3 18 -18 1.5 9 1.5 27 Total credits of 3rd semester: 27 SCHEME OF EXAMINATION Marks Course Code PH201 PH202 PH203 PH204 PH205 PH206 MB220 PH207 Course Pathophysiology Pharmacognosy & Phytochemistry-I Organic Chemistry-I Pharmaceutical Analysis-I Pharmaceutical Engineering-III Pharmaceutical Jurisprudence Life Management Skills Seminar-I © CHARUSAT 2012 Theory University Institute Level Level Evaluation Evaluation 80 20 80 20 Practical University Institute Level Level Evaluation Evaluation --80 20 80 80 20 20 80 80 20 20 80 20 80 20 80 20 -- -- -- -- -- 50 -320 50 180 --Total 480 120 Total marks of 3rd semester: 1100 Page 12 of 240 CHAROTAR UNIVERSITY OF SCIENCE & TECHNOLOGY BACHELOR OF PHARMACY (B. Pharm.) PROGRAMME SEMESTER 4 SCHEME OF TEACHING Course Code PH208 PH209 PH210 PH211 PH212 PH213 PH214 Contact hours per week Theory Practical Course Name Pharmacology-I Pharmacognosy & Phytochemistry-II Organic Chemistry-II Pharmaceutical Analysis-II Physical Pharmaceutics Hospital & Community Pharmacy Seminar-II Theory Credits Practical 3 3 3 3 3 3 1.5 1.5 Total 4.5 4.5 3 3 3 3 3 3 3 -- 3 3 3 3 1.5 1.5 1.5 -- 4.5 4.5 4.5 3 -18 3 18 -18 1.5 9 1.5 27 Total Total credits of 4th semester: 27 SCHEME OF EXAMINATION Marks Course Code PH208 PH209 PH210 PH211 PH212 PH213 PH214 Course Name Pharmacology-I Pharmacognosy & Phytochemistry-II Organic Chemistry-II Pharmaceutical Analysis-II Physical Pharmaceutics Hospital & Community Pharmacy Seminar-II Total © CHARUSAT 2012 Theory University Institute Level Level Evaluation Evaluation Practical University Institute Level Level Evaluation Evaluation 80 80 20 20 80 80 20 20 80 80 20 20 80 80 20 20 80 80 20 20 80 -- 20 -- -- -- -- 50 400 150 480 120 Total marks of 4th semester: 1150 Page 13 of 240 CHAROTAR UNIVERSITY OF SCIENCE & TECHNOLOGY BACHELOR OF PHARMACY (B. Pharm.) PROGRAMME SEMESTER 5 SCHEME OF TEACHING Course Contact Hours/Week Credits Code Name Theory Practical Total Theory Practical Total PH301 Pharmacology -II 3 3 6 3 1.5 4.5 PH302 Pharmacognosy & Phytochemistry-III 2 --- 2 2 --- 2 PH303 Medicinal Chemistry-I 3 3 6 3 1.5 4.5 PH304 Pharmaceutical Biochemistry-I 3 3 6 3 1.5 4.5 PH305 Pharmaceutical Microbiology 3 3 6 3 1.5 4.5 PH306 Pharmaceutical Biotechnology 2 --- 2 2 --- 2 MA331 Biostatistics 2 3 5 2 1.5 3.5 PH307 Seminar III --- 3 3 -- 1.5 1.5 18 36 18 9 27 Total 18 th Total credits of 5 semester: 27 SCHEME OF EVALUATION Course Theory Practical University Institute Total University Institute Total Code Name PH301 Pharmacology -II 80 20 100 80 20 100 PH302 Pharmacognosy & Phytochemistry-III 80 20 100 --- --- --- PH303 Medicinal Chemistry-I 80 20 100 80 20 100 PH304 Pharmaceutical Biochemistry-I 80 20 100 80 20 100 PH305 Pharmaceutical Microbiology 80 20 100 80 20 100 PH306 Pharmaceutical Biotechnology 80 20 100 --- --- --- MA331 Biostatistics 80 20 100 80 20 100 PH307 Seminar III --- --- --- --- 50 50 560 140 700 400 150 550 Total Total marks of 5th semester: 1250 © CHARUSAT 2012 Page 14 of 240 CHAROTAR UNIVERSITY OF SCIENCE & TECHNOLOGY BACHELOR OF PHARMACY (B. Pharm.) PROGRAMME SEMESTER 6 SCHEME OF TEACHING Course Contact Hours/Week Credits Code Name Theory Practical Total Theory Practical Total PH308 Pharmacology-III 3 3 6 3 1.5 4.5 PH309 Pharmacognosy & Phytochemistry-IV 3 3 6 3 1.5 4.5 PH310 Medicinal Chemistry-II 2 3 5 2 1.5 3.5 PH311 Pharmaceutical Biochemistry-II 2 3 5 2 1.5 3.5 PH312 Biopharmaceuticals 3 3 6 3 1.5 4.5 PH313 Biopharmaceutics & Pharmacokinetics 3 - 3 3 - 3 PH314 Pharmaceutical Softwares - 3 3 - 1.5 1.5 MB301 Pharmaceutical Management-I 2 - 2 2 - 2 18 36 18 9 27 Total 18 th Total credits of 6 semester: 27 SCHEME OF EVALUATION Course Theory Practical University Institute Total University Institute Total Code Name PH308 Pharmacology-III 80 20 100 80 20 100 PH309 Pharmacognosy & Phytochemistry-IV 80 20 100 80 20 100 PH310 Medicinal Chemistry-II 80 20 100 80 20 100 PH311 Pharmaceutical Biochemistry-II 80 20 100 80 20 100 PH312 Biopharmaceuticals 80 20 100 80 20 100 PH313 Biopharmaceutics & 80 20 100 -- -- -- Pharmacokinetics PH314 Pharmaceutical Softwares -- -- -- -- 50 50 MB301 Pharmaceutical Management-I 80 20 100 -- -- -- 560 140 700 400 150 550 Total th Total marks of 6 semester: 1250 © CHARUSAT 2012 Page 15 of 240 CHAROTAR UNIVERSITY OF SCIENCE & TECHNOLOGY BACHELOR OF PHARMACY (B. Pharm.) PROGRAMME SEMESTER 7 Scheme of teaching Course Contact Hours/Week Credits Code Name Theory Practical Project Total Theory Practical Project Total PH401 Clinical Pharmacy & Pharmacotherapeutics-I Herbal Drugs Technology-I 3 3 --- 6 3 1.5 -- 4.5 2 3 --- 5 2 1.5 -- 3.5 PH402 PH403 Medicinal Chemistry-III 3 --- --- 3 3 --- -- 3 PH404 Pharmaceutical Analysis - III 3 3 --- 6 3 1.5 -- 4.5 PH405 Dosage Form Design 2 3 --- 5 2 1.5 -- 3.5 PH406 Pharmaceutical Technology-I 3 3 --- 6 3 1.5 -- 4.5 MB401 Pharmaceutical Management-II 2 -- --- 2 2 -- -- 2.0 PH407.01* Elective-I (Pharmaceutical Instrumentation & Technology-I) Elective-I (Pharmaceutical Documentation-I) Elective-I (Pharmaceutical Marketing-I) Total PH 407.02* PH407.03* 3 --- 1.5 3 --- --- 36 1.5 --- --- --- 27 th Total credits of 7 semester: 27 *Please refer to the Note on the next page. Scheme of Evaluation Course Theory Practical Code Name University Institute Total University Institute Total PH401 80 20 100 80 20 100 PH 402 Clinical Pharmacy & Pharmacotherapeutics-I Herbal Drugs Technology-I 80 20 100 80 20 100 PH 403 Medicinal Chemistry-III 80 20 100 --- --- --- PH 404 Pharmaceutical Analysis - III 80 20 100 80 20 100 PH405 Dosage Form Design 80 20 100 80 20 100 PH406 Pharmaceutical Technology-I 80 20 100 80 20 100 MB401 Pharmaceutical Management-II 80 20 100 --- --- --- Sub Total 560 140 700 400 100 500 Elective courses code PH407.01 PH407.02 PH407.03 Theory/Practical/project Elective courses name Elective-I (Pharmaceutical Instrumentation & Technology-I) Elective-I(Pharmaceutical Documentation-I) University Institute Total 80 20 100 Elective-I (Pharmaceutical Marketing-I) Total marks of 7th semester: 1300 © CHARUSAT 2012 Page 16 of 240 CHAROTAR UNIVERSITY OF SCIENCE & TECHNOLOGY BACHELOR OF PHARMACY (B. Pharm.) PROGRAMME NOTE For the course of PH 407 Elective I (at 7th Semester) and the course of PH 414 Elective II (at 8th Semester), every student is expected to give his/her choice in the beginning of the 7th Semester. The student can select any one group (A/B/C) as per the following scheme: Elective-I (7th Semester) Group Code A PH407.01 Name Elective-I (Pharmaceutical Elective-II (8th Semester) Code PH414.01 Instrumentation & Technology-I) B PH407.02 Elective-I (Pharmaceutical PH407.03 Elective-I (Pharmaceutical Marketing-I) © CHARUSAT 2012 Elective-II (Pharmaceutical Instrumentation & Technology-II) PH414.02 Documentation-I) C Name Elective-II ( Pharmaceutical Documentation-II) PH414.03 Elective-II ( Pharmaceutical Marketing-II) Page 17 of 240 CHAROTAR UNIVERSITY OF SCIENCE & TECHNOLOGY BACHELOR OF PHARMACY (B. Pharm.) PROGRAMME SEMESTER 8 Scheme of teaching Course Contact Hours/Week Credits Code Name Theory Practical Project Total Theory Practical Project Total PH408 3 3 --- 6 3 1.5 --- 4.5 PH409 Clinical Pharmacy & Pharmacotherapeutics-II Herbal Drugs Technology-II 2 -- --- 2 2 -- --- 2.0 PH410 Medicinal Chemistry-IV 3 3 --- 6 3 1.5 --- 4.5 PH411 Pharmaceutical Analysis-IV 3 --- --- 3 3 -- --- 3.0 PH412 Pharmaceutical Technology-II 2 3 --- 5 2 1.5 --- 3.5 PH413 Novel Drug Delivery System 2 -- --- 2 2 -- --- 2.0 MB402 Entrepreneurship for PharmaProfessionals Elective-II (Pharmaceutical Instrumentation & Technology-II) Elective-II ( Pharmaceutical Documentation-II) Elective-II ( Pharmaceutical Marketing-II) Total 3 3 3 9 3 1.5 1.5 6 PH414.01* PH414.02* PH414.03* 3 --- 1.5 3 --- --- 36 --- 1.5 --- --- 27.0 th Total credits of 8 semester: 27 *Please refer to the Note on the next page. Scheme of Evaluation Course Theory Practical Project Code Name University Institute Total University Institute Total University Institute PH408 Clinical Pharmacy & PharmacotherapeuticsII Herbal Drugs Technology-II Medicinal ChemistryIV Pharmaceutical Analysis-IV Pharmaceutical Technology-II Novel Drug Delivery System Entrepreneurship for Pharma- Professionals Sub Total 80 20 100 80 20 100 -- -- 80 20 100 -- -- --- -- -- 80 20 100 80 20 100 -- -- 80 20 100 -- -- --- -- -- 80 20 100 80 20 100 -- -- 80 20 100 -- -- --- -- -- 80 20 100 40 10 50 40 10 50 560 140 700 280 70 350 40 10 50 PH409 PH410 PH411 PH412 PH413 MB402 Elective courses Theory/Practical/project Elective courses name code University Institute Total 80 20 100 PH414.01 Elective-II (Pharmaceutical Instrumentation & Technology-II) PH414.02 Elective-II (Pharmaceutical Documentation-II) PH414.03 Elective-II (Pharmaceutical Marketing-II) Total marks of 8th semester: 1200 © CHARUSAT 2012 Page 18 of 240 Total CHAROTAR UNIVERSITY OF SCIENCE & TECHNOLOGY BACHELOR OF PHARMACY (B. Pharm.) PROGRAMME NOTE For the course of PH 407 Elective I (at 7th Semester) and the course of PH 414 Elective II (at 8th Semester), every student is expected to give his/her choice in the beginning of the 7th Semester. The student can select any one group (A/B/C) as per the following scheme: Elective-I (7th Semester) Group Code A PH407.01 Name Elective-I (Pharmaceutical Elective-II (8th Semester) Code PH414.01 Instrumentation & Technology-I) B PH407.02 Elective-I (Pharmaceutical PH407.03 Elective-I (Pharmaceutical Marketing-I) © CHARUSAT 2012 Elective-II (Pharmaceutical Instrumentation & Technology-II) PH414.02 Documentation-I) C Name Elective-II ( Pharmaceutical Documentation-II) PH414.03 Elective-II ( Pharmaceutical Marketing-II) Page 19 of 240 Bachelor of Pharmacy Programme SYLLABI (Semester – 1) CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY © CHARUSAT 2012 Page 20 of 240 HUMAN ANATOMY & PHYSIOLOGY-I (PH101) (Theory) Credits: 3 Contact Hours per week: 3 Objective of the Course: To make students familiar with the principles of human anatomy and physiology as well as basic concepts related to health. Student Learning Outcomes/Objectives: At the end of the course, the student will be able to understand the concept of anatomy and physiology of different organ systems which is a prerequisite for understanding the concepts of pharmacology. In addition they will be able to know about different diseases and their causative organism. Instructional Methods and Pedagogy: Faculty member/s shall explain in a class room using black board and multimedia projector, charts and models of different organ systems. Outline of the Course: No. Unit Minimum No. Approx. of Contact Hours Weightage % 1 Introduction to Anatomy & Physiology 2 3 2 The Cell 4 10 3 Tissues 3 10 4 Muscular system 3 15 5 Sense organs 6 10 6 Nervous system 11 20 7 Reproductive system 3 10 8 Endocrine system 8 10 9 Osseous system 3 5 10 Introduction to microbes 1 5 11 The concept of Epidaemiology 1 2 45 100 % Total © CHARUSAT 2012 Page 21 of 240 Detailed Syllabus: No. 1 Unit Details Introduction to Anatomy & Physiology: Contact hours References 2 5,14 4 5,3,11 3 5,3,8 3 5,3 6 5 - Fundamental & Scope of Anatomy & Physiology. - Anatomical terms in relation to parts of the body system & organs. 2 The Cell: - Molecular structure & function of cell. - Mechanism & electrophysiology of cell membrane including various transport mechanisms. - Cell cycle (Genetic control of cell function & its significance). 3 Tissues: - Introduction & organization to elements of tissue. - Functions of different tissues( Epithelial, Connective, Muscular & Nervous tissue). 4 Muscular system: - Their gross & molecular level anatomy and physiology of skeletal muscle. - Physiology of muscle contraction. - Physiological properties of skeletal muscles and their disorders. 5 Sense organs: - Basic anatomy and physiology of eye (vision), ear (hearing), taste buds, nose (smell). - Structure & function of skin (superficial receptors). - Regulation of body temperature. © CHARUSAT 2012 Page 22 of 240 No. 6 Unit Details Nervous system: Contact hours References 11 5,3 3 5,6 8 5,3 3 5,11 - Neurons & Nerve fibers: Physiology of nerve excitation & conduction. (Sensory & motor nerves). - Central nervous system: Specialized function of different parts of brain and spinal cord, Neurohumoral transmission in the CNS, Reflex action, RAS, Limbic System. - Electroencephalogram, Physiology of sleep, CSF. - Autonomic nervous system: Physiology and function of ANS, Mechanism& significance of the neurohumoral transmission in the ANS. - Peripheral Nervous System (PNS):Description & function of Cranial & Spinal nerves. - Demonstration of reflex action. 7 Reproductive system: - Male and female reproductive system and their hormones. - Physiology of menstruation, coitus and fertilization. Sex differentiation, spermatogenesis and cogenesis. Pregnancy its maintenance and parturition. 8 a) Endocrine system (Hormones): Basic anatomy and physiology of pituitary, thyroid, parathyroid, adrenals, pancreas, testis and ovary, their hormones and function. Brief outline of their disorders. b) Autocoids (Local hormones): Histamine, 5-HT, prostaglandin, Thromboxanes, Leukotrienes PAF and peptides, their function and importance. 9 Osseous system: Structure, composition and function of skeleton, classification of joints, Types of movements at joints, disorder of bones and joint. © CHARUSAT 2012 Page 23 of 240 No. 10 Unit Details Introduction to microbes: Contact hours References 1 13 1 13 Classification of microbes, isolation, staining techniques of organisms of common diseases. 11 Epidaemiology: - Its scope, methods, uses and dynamics of disease transmission. (Endemic, Epidemic, Pandemic). - Immunity and immunization: Immunological products and their dose schedule. - Principles of disease control and prevention, hospital acquired infection, prevention and control. - Disinfection, types of disinfection, disinfection, procedures, for faeces, urine, sputum, room linen, dead-bodies, instruments. Recommended study materials: 1. Fundamentals of anatomy and physiology; Martini F; Prentice hall; 2nd Ed. 1992. 2. Anatomy and physiology; Seeley R. R., Stephens T. D. and Tate P., Mosby, St Louis; 3rd Ed. 1995. 3. Text book of medical physiology; Guyton; W. B. Saunders Co.; Philadelphia; 8th Ed.; 1991. 4. West J. B. Best and Taylor’s physiological basis of medical practice; Williams and Wilkins, Baltimone; 12th Ed.1989. 5. Principles of anatomy and physiology; Tortora G. J. and Anagnodokos, N. P.; Harper and Colling Publishers, New York; 7th Ed. 1992. 6. Human anatomy, physiology and health education; Gandhi T. P.; B. S. Shah Prakashan, Ahmedabad; 9th Ed. 1998. 7. Preparatory Manual for undergraduates’ physiology; Joshi V. D.; B. I. Churchill Livingstone; 1995. 8. Human physiology; Chatteerjee C.C.; Medical Allied Agency Calcutta; 10th Ed.1985. 9. Physiology and anatomy; Clancy, John and MoVicet A.J.; Edward Arnold; 1995. 10. Human Physiology; Shalya S.; C. B. S. Publishers New Delhi; 1st Ed. 1994. 11. Human Anatomy; Chaurasia B.O.; C. B. S. Publishers New Delhi; 3rd Ed. 1994. © CHARUSAT 2012 Page 24 of 240 12. Anatomy and physiology in health and illness; Ross and Wilson’s; Churchill Livingstone; 8th Ed. 1995. 13. Health Education and Community Pharmacy; Parmar N. S.; C. B. S. Publishers, New Delhi; 1995. 14. Practical anatomy Physiology and biochemistry; Goyal R. K.; B. S. Shah Prakashan, Ahmedabad; 1994. 15. A textbook of history; Garg K. et. al; C. B. S Publishers, New Delhi; 2nd Ed.1991. 16. Text books of histology; Lesson C. R. et. al.; W. B. Saunders Co.5th Ed. 17. Atlas of anatomy; Aqur, Anne M.R.; Williams and Wilkins; 9th Ed.1991. 18. A photographic atlas for the anatomy and physiology lab.; Van de Graaff and Crewley, J. L.; Mortan Publishing Co.; 3rd Ed. 1991. 19. A text book of practical physiology; Ghai C. L.; Jaypee Brothers Medical Publishers (P) Ltd.; 4th Ed. 1998. (Practical) © CHARUSAT 2012 Page 25 of 240 BASIC PHARMACOGNOSY-I (PH102) (Theory & Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the Course: To make students familiar with the concept of Pharmacognosy, the scientific studies of the natural products utilized as drugs. Student Learning Outcomes / Objectives: At the end of the course, the student should understand the preliminary basis of Pharmacognosy. The students are expected to • Understand different methods to cultivate the medicinal plants • Differentiate between different types of the organs of medicinal plants • Understand various options available- in vivo and in vitro to improve the quality of the phytoconstituents obtained from the natural sources. Instructional Methods and Pedagogy: The faculty shall explain the lectures • Using black board, • Using Over Head Projector, Multimedia projector. • Through visit of herbal garden Outline of the Course (Theory): No. Unit Minimum No. of Contact Hours Approx. weightage % 1 Introduction and scope of Pharmacognosy. 5 10 2 Sources of drugs. 7 10 3 Classification of drugs. 6 15 4 Cultivation, collection, processing and storage of 10 20 crude drugs. 5 Introduction to Plant Cell and tissues. 5 10 6 Morphology and histology of different plant parts. 12 35 45 100 % Total © CHARUSAT 2012 Page 26 of 240 Detailed Syllabus (Theory): No. Contact References Unit details Hours 1 Introduction and scope of Pharmacognosy: 5 1, 3, 4, 6, 8 7 1, 3, 4, 6 6 1, 3, 4, 6 10 1, 3, 4, 6, 8 5 1, 2, 3, 4 12 2, 3, 4, 7, 9 Definition and Historical background, present status, development and future scope of Pharmacognosy. 2 Sources of drugs: Plant source, Biological source, Marine and Minerals. Tissue culture technique – as a source of drugs. 3 Classification of drugs: Alphabetical, Morphological, Taxonomical, Chemical, pharmacological and Chemo taxonomical classification. 4 Cultivation, collection, Processing and storage of crude drugs: Factors influencing cultivation of medicinal plants. Types of soils and fertilizers of common use. Plant hormones and their application. Introduction and application of Polyploidy, Mutation and Hybridization with reference to medicinal plants. 5 Introduction to Plant Cell and tissues: Plant cell Structure and non-living inclusion Different types of plant tissues and their function. 6 Morphology and histology of different plant parts: Morphology and histology of root, stem, leaf. Morphology of bark, wood, flower, fruit and seed. Modification of root and stem. © CHARUSAT 2012 Page 27 of 240 Detailed Syllabus (Practical): No. Aim of the Practical 1 Introduction and functioning of microscopes. 2 Histological examination of Monocot Leaf. 3 Histological examination of Dicot Leaf. 4 Histological examination of Monocot Root. 5 Histological examination of Dicot Root. 6 Histological examination of Monocot Stem. 7 Histological examination of Dicot Stem. 8 Morphological studies of Flowers and inflorescences. 9 Morphological studies of Fruit. 10 Morphological studies of aerial and underground parts of the plants. 11 Studies on modifications of stem and root. 12 Studies of different types of plant tissues. (Parenchyma, Sclerenchyma, Collenchyma, Vascular Tissues, Special Tissues) Recommended study materials: a) Text books: 1. Pharmacognosy; C. K. Kokate, A. P. Purohit, S. B. Gokhale; Nirali prakashan, Pune; 39th Edition; 2007. 2. Botany for degree students; A. C. Dutta; Calcutta Oxford university press, New Delhi; 15 impressions; 1994. 3. A textbook of Pharmacognosy; Mamta Shah, Urvashi Shah, Sangita Marfatia; Nirav and Roopal Prakashan; 2008-09. 4. Textbook of Pharmacognosy I; S. B. Dhake, Parul B. Patel; Nirav and Roopal Prakashan; 2008-09. 5. Pharmacognosy; J. S. Quadry; B. S. Shah Prakashan, Ahemedabad; 14th edition; 200809. b) Reference books: 6. Pharmacognosy; V. E. Tylar, L. R. Brady, J. E. Habbers; Lea and Febgir Philadelphia; 8th edition; 1981. 7. Pharmacognosy of powdered crude drugs; M. A. Tyenger; Manipal power press; 1st Edition; 1974. © CHARUSAT 2012 Page 28 of 240 8. Trease and Evan’s Pharmacognosy; W. C. Evans; W. B. Saunders Co., Singapore; 15th Edition; 2008. 9. Text Book Pharmacognosy; T.E. Wallis; CBS Publishers and Distributors, Delhi; 5th Edition; Reprint-2005. © CHARUSAT 2012 Page 29 of 240 PHARMACEUTICAL CHEMISTRY-I (INORGANIC) (PH103) (Theory & Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the course: • The course is designed to make students familiar with the principles of inorganic chemistry as applied to pharmaceuticals and to study inorganic agents used as pharmaceutical aids, therapeutic agents and diagnostic agents. Students learning outcomes/objectives: • The course will help the student to have a good understanding of the history and basic concepts of medicinal inorganic chemistry. • Students should be able to describe in detail synthetic approaches as well as mechanisms of action of some important metal-based therapeutic and diagnostic agents. • The course may help the students in understanding rational approaches towards the design of important therapeutic agents and their biological implications. Instructional methods and pedagogy: • The faculty shall explain the lectures using black board, Over Head Projector or Multimedia projector. Outline of the course (Theory): Unit No. Minimum No. of Approx. Contact hours. Weightage % 1 Pharmacopoeia and monograph 04 15 2 Sources of contamination in pharmaceuticals and 04 10 31 65 methods to control 3 An outline of methods of preparation uses, sources, impurities, tests for purity and identity, including various limit tests, and special tests, if any for the classes of inorganic pharmaceuticals included in the current edition of the Indian Pharmacopoeia. 4 Water 03 5 5 Important inorganic gases used in pharmacy 03 5 45 100 % Total © CHARUSAT 2012 Page 30 of 240 Detailed syllabus (Theory): No. 1 Unit details Pharmacopoeia and monograph Contact Hours References 04 1 04 1, 2,3 Different pharmacopoeia and contents of official monograph. 2 Sources of contamination in pharmaceuticals and methods to control - Purity of Pharmaceuticals and factors affecting purity of pharmaceuticals - Limit test for chlorides, sulphates, arsenic, iron, lead, heavy metals as per I.P. 3 An outline of methods of preparation uses, sources, impurities, tests for purity and identity, including various limit tests, and special tests, if any of the following classes of inorganic pharmaceuticals included in the current edition of the Indian Pharmacopoeia. - Dental products 03 1,2,3,4,8,11 Dentifrices, anti- caries agents. - Antidotes 02 1, 2,3,8,11 Classification, Sodium thiosulphate, Sodium nitrite. - Gastrointestinal tract agents 06 1,2,3,4,8,11 A) Acidifying agents-dil HCl B) Antacids-Sodium bicarbonate, Aluminum hydroxide, Aluminum phosphate, Basic aluminum carbonate, Calcium Phosphate, Magnesium carbonate, Milk of magnesia. C) Protectives and Adsorbents-Bismuth compounds, Bismuth sub carbonate, Bismuth subgallate, Bismuth sodium tartarate, Kaolin, Activated charcoal, Pectin. D) Saline cathartics-Sodium phosphate, Sodium potassium tartarate, Magnesium carbonate, Magnesium oxide. © CHARUSAT 2012 Page 31 of 240 No. 3 Unit details - Essential and trace ions Contact Hours References 07 1, 2,3,8,11 02 1, 2,3,8,11 08 1, 2,3,8,11 03 1, 2,3,8,11 03 1,2,3 03 2,3 (Conti.) Absorption, distribution, physiological role. Official compounds of Iron, Copper, Zinc, Manganese, Iodine, Ferrous sulfate, Iron sorbite injection, Ferric ammonium citrate, ferric chloride, Copper sulfate, Iodine, Potassium iodide, Sodium iodide, Zinc sulphate. - Expectorants and emetics Ammonium chloride, Potassium iodide, Antimony Potassium tartarate. Mode of action of above mentioned compounds. - Topical agents General introduction and mode of action: A) Protectives- Talc, Zinc oxide, Calamine, Zinc stearate, Titanium dioxide, Aluminum compounds. B) Antimicrobials and astringents: Hydrogen peroxide solution, Sodium perborate, Zinc peroxide, Potassium permanganate, Sodium hydrochloride, Iodine solution and nitrate, Mercuric oxide, Mercuric chloride and sulphate, Boric acid, Selenium sulfide, Zinc sulfate. - Complexing and chelating agents Complexing and chelating agents used in therapy. 4 Water Hardness of water, methods to remove hardness of water, different official waters and official quality control tests for waters. 5 Important inorganic gases used in pharmacy Oxygen, Nitrogen, Nitrous Oxide, Carbon dioxide, Helium, Ammonia and their compounds as per I.P. Note: For official compounds; general properties, assays, storage and uses should be discussed. © CHARUSAT 2012 Page 32 of 240 Detailed syllabus (Practical): No. Aim of Practical 1 2 3 Semi-micro inorganic qualitative analysis of Given Inorganic mixtures (Minimum 07) PbNO3 + KCl MgSO4+K2CO3 MgCl2+KNO3 FeSO4+ZnCl2 K2CrO4+AgCl2 KI+FeCl3 ZnSO4+CaCO3 CdCl2+KBr KNO3+MgSO4 (NH4)2NO3+MgCl2 BaSO4+HgCl2 MnSO4+KCl AlCl3+PbCl2 Limit test( Minimum 04) Limit test for Chlorides Limit test for sulfate Limit test for Iron Limit test for Lead Limit test for Arsenic Assay of following compounds as per pharmacopoeia. (Minimum 04) Assay of Boric acid Assay of CuSO4 Assay of FeSO4 Assay of Calcium lactate Assay of Calcium gluconate © CHARUSAT 2012 Page 33 of 240 Recommended study material: 1. Indian Pharmacopoeia; Government of India; 2007. 2. Medicinal and Pharmaceutical Chemistry Inorganic; J. H. Block, E. B. Roche; Varghese Publication; Indian edition. 3. Text Book of Pharmaceutical Chemistry Revised by L. M. Atherden, Bentley & Driver’s; Oxford Medical Publications, 8th edition. 4. The Science and Practice of Pharmacy by Remington, Lipincott, William and Wilkins; 20th edition. 5. Advanced Inorganic Chemistry; Cotton & Wilkinson; Wiley Eastern Ltd., Delhi, 18th Edition. 6. Inorganic Pharmaceutical Chemistry (Practical), Dhake & Belsare; 2nd Edition. 7. Text Book of Quantitative Chemical Analysis; Vogel’s; ELBS UK, 5th Edition, 1996. 8. Quantitative Inorganic Analysis; Vogel’s; ELBS UK, 5th Edition, 1996. 9. Practical Pharmaceutical Chemistry Vol. I & II; A.H. Beckett & J.B. Stenlake, CBS. Publishers; New Delhi, 4th Edition, 1986. 10. Inorganic Pharmaceutical Chemistry; T. O. Spine and C. O. Wilson, Roger’s, Lea & Febiger, Philadelphia, USA, 8th edition, 1967. 11. Pharmaceutical Chemistry-Inorganic; G. R. Chatwal; Goel Publishing House. © CHARUSAT 2012 Page 34 of 240 PHARMACEUTICAL ENGINEERING-I (PH104) (Theory & Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the course: • To study basic mechanism of material transportation, this is used in pharmaceutical industries. • Subject gives the guideline for handling of liquid, solid and gaseous material in various places in pharmacy. Students learning outcomes/objectives: • By the end of this course, the student should have a good understanding of the basic concepts of material handing in various field of pharmacy. • Students should be able to know the appropriate instrumental requirement for measurement of various flow of fluid and shifting of solid material. Instructional methods and pedagogy: The lectures will be delivered using • Black board • Over Head Projector or Multimedia projector Outline of the course (Theory): No. Unit Minimum No. Approx. of contact Weightage % hours 1 Flow fluids 08 18 % 2 Stoichiometry 08 18 % 3 Heat transfer 08 18 % 4 Mass Transfer 05 11 % 5 Material handling systems 06 13 % 6 Materials 06 13 % 04 09 % 45 100 % of Pharmaceutical Plant Construction 7 Packaging of Materials Total © CHARUSAT 2012 Page 35 of 240 Detailed syllabus (Theory): No. 1. Unit details Flow fluids: Contact Hours References 8 1,3,4 8 1 8 1 5 1 Type of flow, Reynolds number and its significance, concept of boundary layer, basic equiation of fluid flow, valve, flow meters, measurement of flow and pressure. 2 Stoichiometry: Unit processes, material and energy balance, molecular unit, mol fraction, tie substance, gas law, mole volume, equilibrium state, rate process, steady and unsteady state, dimensionless equiation and formulas, different types of graphic representation, application of gas law, mathematical problems. 3 Heat transfer: Modes of heat transfer. Conduction- Fourier’s law, resistances in series and parallel, use of mean area and mean temperature difference. Convection-Concept of film, overall coefficient, heat transfer by forced convection in laminar and turbulent flow, condensing vapours, evaluation of individual film coefficients. Radiation-Black body, absorptivity & emmisivity. Heating of fluids, steam as heating medium, properties and uses of steam, steam traps, study of steam table. Heat exchange equipmentsHeat exchangers, condensers, boilers, extended surface scraped and surface equipments etc. Applications of heat transfer in industrial processes. Mathematical problems. 4 Mass Transfer: Principle, streams in mass-transfer operations, solid/fluid and fluid/fluid mass transfer, influence of mass transfer on unit operations. © CHARUSAT 2012 Page 36 of 240 No. Unit details 5 Contact Hours Material handling systems: References 6 5 6 5 4 5,6 Solids handling- storage, conveyers, vacuum & pneumatic conveying. Liquid handling- storage, pumps. Gases- Fans, blowers and compressors. Colour coding of Pipelines, use of forklifts and pallets, store design in pharmaceutical industries. 6 Materials of Pharmaceutical Plant Construction: General study of composition, corrosion resistance, properties, factors affecting the selection of material of pharmaceutical plant construction with special reference to stainless steel and glass. Corrosion-types, causes, theories of corrosion and its prevention. 7 Packaging of Materials:Function and qualities of package, type of packaging materials, merits and demerits of packaging materials, pressure pack of pharmaceutical product. Detailed syllabus (Practical): No. Aim of Practical 1 To study conversion factors and use of these conversion factors. 2 To calibrate the given Ventrurimeter and to find out the co efficient of discharge. 3 To calibrate the given Orificemeter and to find out the co efficient of discharge. 4 To calibrate the given Rotameter with plummet. 5 Measurement of flow of fluids and their pressure and calculate the Reynolds number. 6 To determine the vacuum creating efficiency of ejector pump. 7 To determine the volume transfer efficiency of ejector pump. 8 To measure the velocity head of the fluid using pitot tube. 9 To measure the pressure of gas passing through the pipeline by difference type of U tube manometer. 10 To determine the overall heat transfer coefficient of a given heat exchanger. 11 To determine the efficiency of given lagging material. © CHARUSAT 2012 Page 37 of 240 Recommended study material: 1. Elementary Chemical Engineering; Max S. Peters; McGraw Hill Book Company, New York; 1954. 2. Perry’s Chemical Engineer’s Handbook; Robert H Perry, Green D.W., Maloney J.O.; McGraw Hill Inc., New York; 7th Edition, 1998. 3. Copper and Gun’s Tutorial Pharmacy; S. J. Carter; CBS Publication & Distribution, New Delhi; 2004. 4. Unit Operations of Chemical Engineering; McCabe Warren, Smith & Harriott; McGraw Hill Inc., New York; 5th edition; 2001. 5. Pharmaceutical Engineering; K. Sambamurthy; New Age International Ltd., New Delhi 2002. 6. Pharmaceutics the Science of Dosage Form Design; M.E. Aulton; Churchill Livingstone, London; 2002. © CHARUSAT 2012 Page 38 of 240 BASIC COMPUTER APPLICATIONS (CE105) (Theory & Practical) Credits: 2 (Theory) Contact Hours per week: 2 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the course: • To study basic fundamental of computers • To study skill of some useful softwares related to pharmaceutical field. • To study the basic operating procedure of computer. Students learning outcomes/objectives: • By the end of this course, the student should have a good understanding of the basic concepts of computer and basic software useful in pharmacy. • Students should gain knowledge of the appropriate operating procedure of computer. Instructional methods and pedagogy: The lectures will be delivered using • Black board, • Over Head Projector • Multimedia projector Outline of the course (Theory): Sr. No. Title of the unit Minimum no. of contact hrs. 3 Approx. Weightage % 10 1 Computer Fundamentals 2 Operating Systems 3 10 3 MS Word 6 20 4 MS Excel 6 20 5 MS PowerPoint 5 17 2 7 1 3 4 13 30 100 % 6 7 8 Introduction to MS Access and Outlook Introduction to software’s for viewing PDF documents Networking, Internet and Intranet Total © CHARUSAT 2012 Page 39 of 240 Detailed syllabus: (Theory) Sr. No. 01 02 03 04 05 Name of Topic Computer Fundamentals Definition, characteristics, history, computer terminology, computer organization, input & output devices, storage devices (including latest devices), classifications of computers (including current computer systems), binary conversions and ASCII code, application of computers in pharmacy, introduction to computer virus, Configuration of Personal computer, Hardware, Types of software, firmware. Operating Systems Definition, functions of an operating system, types of operating systems and their characteristics, Installation of Operating System, system utility Windows Desktop, start-menu, control panel, accessories, my computer, my documents, recycle bin, printer and mouse settings, maximizing, minimizing, restoring and closing of windows, windows explorer MS Word Word Essentials, the word workplace, Parts of MS Word screen, Typing and Editing, Finding and Replacing, Autocorrect and Auto text, Reusing Text and Graphics, use of spell-check & grammer, thesaurus and scientific Symbols, viewing of document by various ways Editing Tools, Formatting Text Formatting Text Character, Formatting Paragraphs, Formatting and Sorting Lists, Page Design and Layout, Page Setup : Margins, Page Numbers, and Other Items, Newspaper -style Columns, Working with Tables Creating and formatting of tables and sorting, merging etc. of data in tables. Inserting, deleting and sizing of rows and columns in tables, Opening, Saving and Protecting Documents, Locating and Managing Documents Printing, Assembling Documents with Mail Merge MS Excel Introduction to EXCEL worksheet, calculations in EXCEL, preparation of templates for application in pharmaceutical chemistry, pharmaceutical technology, pharmacology and pharmacognosy. Hierarchy of operation, library functions such as logarithm, square root, sum, average,. Drawing graphs in EXCEL line graph, histogram, pie-chart- At least one graph for each discipline of chemistry, pharmaceutical technology, pharmacology and pharmacognosy –Editing chart features such as annotation, labeling of axis, changing legends etc. MS PowerPoint Creating and viewing a presentation, adding animations and managing slide shows etc. © CHARUSAT 2012 Contact Hours Reference Book 03 10,12 03 10,12 06 3,4,5,7 06 7,9,10 05 7,9,10 Page 40 of 240 06 07 08 Introduction to MS Access and Outlook Introduction to software’s for viewing PDF documents (ADOBE reader, ACROBAT), Drawing simple chemical structures (CHEMSKETCH, etc.) Networking, Internet and Intranet Introduction to network and networking devices, Computer networks, networking technology, components of network. Internet – Basic terms, software and hardware requirement for internet, process of internet working, internet tools, Email- components and working, study of pharmaceutical web sites and search engines, searching through pharmaceutical data bases, study of patent websites. 02 9,10 01 11 04 13,14 Detailed syllabus (Practical): Sr. No. 01 02 03 04 05 06 07 08 09 10 11 12 List of Practical Introduction to computers • Components and operating of computers • Typing of a given document MS DOS commands for creating, saving, renaming & modifying files & folders MS Word • Creating and Saving of given document • Use of page setup for given document MS Word • Inserting header & footer, page number in given document • Use of page break in given document • Cut –Copy – Paste, Undo & Redo of text by various ways MS Word • Formatting of text and paragraphs by various ways • Use of Bullets & Numbering, Borders & Shading etc. in given document MS Word • Writing a document in newspaper type columns • Use of find, replace, go to, spelling & grammer command in given document MS Word • Writing Greek words and scientific symbols in MS Word • Creating and formatting of tables as per given instructions. MS Word write a letter using mail merge MS Excel Use of library functions such as logarithm, square root, sum, average MS Excel Drawing of charts and graphs like line graph, histogram, pie-chart Editing chart features such as annotation, labeling of axis, changing legends MS Power Point Creating and viewing a presentation MS Power Point Adding animations and managing slide show © CHARUSAT 2012 Page 41 of 240 13 14 15 Software Use Drawing simple chemical structures using software like CHEMSKETCH Making of simple papers of charts using software like COREL DRAW/PAGE MAKER (DTP) Internet/Intranet Demonstration of internet working Demonstration of E-mail Working Internet/Intranet Demonstration of Pharmaceutical Websites Mainly drug information sites & patent websites Recommended study material: 1. Windows Vista: Step by Step, Joan Preppernau and Joyce Cox, Prentice Hall of India, New Delhi, 2007. 2. Windows Vista: Plain & Simple, Jerry Joyce, and Marianne Moon, Prentice Hall of India, New Delhi, 2007. 3. WORD 2000, Guy Hart Davis, BPB Publications, New Delhi, 1999. 4. WORD 2000: fast & easy, Diane Koers, BPB Publications, New Delhi, 2000. 5. Microsoft WORD 2000:Training Guide, Maria Reid, BPB Publications, New Delhi, 2000 6. Exploring Microsoft Office XP, John Breeden and Michael Cheek, BPB Publications, New Delhi, 2001. 7. MS Office by Pierce, Prentice Hall of India, New Delhi, 2007 9. MS Office: Plain & Simple, Jerry Joyce, and Marianne Moon, Prentice Hall of India, New Delhi, 2007. 8. MS Office: Step by Step, Joyce Cox, Prentice Hall of India, New Delhi, 2007. 9. Taxali R.K., P.C. Software for Windows 98 made simple – 8th Edition – 2002 – Tata Mc, New Delhi. 10. MS – Office by Ed. Bott. & Woddy Leohad, Prentice Hall of India, New Delhi, 1999 11. Manuals available with the software. 12. Working with personal computer software: R.P.Soni, Harshal Arolkar, Sonal Jain, Books India Publications, First Edition, New Delhi, 2008. 13. Computer Fundamentals with Pharmacy Applications: N.K.Tiwari, PharmaMed Press, New Delhi, 2008. 14. Computers In Pharmacy: Praveen S. Thakur, Rachna Manchanda, Pratibha Nand, Birla Publications Pvt. Ltd., Third Edition, New Delhi, 2008. © CHARUSAT 2012 Page 42 of 240 BASIC MATHEMATICS (MA131) (Theory) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) Objective of the Course: To introduce the basic concepts of Mathematics to students passing HSC with B-group. Pre-requisite: No additional Pre-requisite required. Methodology: The emphasis during Lecture sessions will be on Understanding of Concepts rather than on complexities of Computational Techniques. Stress is also given on Visual perception through Mathematical Software. Relevant Illustrations will be provided from the Real World processes. Sufficient home assignments will be given to the students which will test their fundamentals and ability to relate Mathematical concepts with reality. Outline of the Course: No. Minimum No. of Approx. Contact Hours Weightage % Unit 1 Sets, Relations and Functions 6 14 2 8 17 3 Concepts of Limit, Continuity and Differentiation Concept of Integration 6 15 4 Matrices and Determinants 6 15 5 Equations and their solutions 8 17 6 Basic Statistics 11 22 45 100 % Total © CHARUSAT 2012 Page 43 of 240 Detailed Syllabus: No. 1 Contact Unit details hours 6 Sets, Relations and Functions: - Sets, Number systems (Real and Complex numbers) - Cartesian Product of sets - Relations One-One, Many-One, One-Many, Many-Many Relations - Functions Certain Standard functions Polynomial, Algebraic, Exponential, Logarithmic, Trigonometric - Visualization of graphs of standard functions - Curves using Mathematical Software. 2 8 Concepts of Limit, Continuity and Differentiation: - Concept of Limits, - Evaluation Techniques - Continuity of functions - Concept of Differentiation - Derivatives of Standard Functions - Evaluation Techniques - Derivative as a Rate of Change - Visualization of graphs of Continuous and Differentiable functions. 3 6 Concept of Integration: - Indefinite Integrals (Primitives / Antiderivatives) - Primitives of Standard Functions - Methods of Integration - Definite Integral - Integration as Area under the curve - Use of Mathematical Software for evaluating Derivatives - Indefinite and Definite Integrals © CHARUSAT 2012 Page 44 of 240 No. 4 Unit details Contact hours 6 Matrices and Determinants: - Matrices - Matrix Operations - Properties of Matrix Operations - Determinants (up to order 3) and their properties - Cofactor expansion - The Inverse of a Matrix - The Rank of a Matrix and Applications. 5 8 Equations and their solutions: - Polynomial equations in single variables - Solution of an equation - Graphical representation of an equation - Standard curves and surfaces - Determination of solution of Quadratic equations - System of Linear equations & its Matrix representation - Consistency and solution of a System of Linear equation using Matrix Inversion 6 11 Basic Statistics: - Ungrouped and Grouped data - Diagrammatic Representation of Data - Measures of Central tendency - Measures of Dispersion - Computations of these measures through Statistical Software © CHARUSAT 2012 Page 45 of 240 Recommended study materials: 1. Calculus and Analytical Geometry; Thomas G. B. and R. L. Finney; Addision Wesley, 9th Ed., 1996. 2. Advanced Engineering Mathematics; Erwin Kreyszig; Jhon Wiley & Sons, India, 8th Ed., 1999. 3. Calculus Early Transcendental; Stewart James; Thomson India; 5th Ed., 2007. 4. Advanced Engineering Mathematics; Wylie & Barrett; Mc graw Hill pub. 5. Advanced Engineering Mathematics; Greenberg M D; Pearson Education, 2nd Edition. © CHARUSAT 2012 Page 46 of 240 COMMUNICATION SKILLS-1 (EN103) (Theory and Practical) Credits: 1 (Theory) Contact Hours per week: 1 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the Course: • To hone basic Communication Skills (LSRW) of the students by exposing them to the key communication techniques, and thereby • To improvise Comprehensional and Expressional Skills of the students required for day to day and classroom, academic and cultural situations. Instructional Method and Pedagogy: • Lectures will be taken in class room and practicals will be conducted in the language lab with the use of multi-media presentations / black board work and mix of both. • Some assignments and Presentation Tasks will be given • Students will also be engaged in interpersonal communication activities such as group discussion, role plays, simulations, just a minute sessions, etc. Outline of the course (Theory and Practical): No. Title of the unit Minimum Approx. number of weightage % hours 1. An Introduction to Communication and Key 08 7 Concepts in Communication 2. Major Communication Techniques and Styles 08 7 3. Listening Skills 08 18 4. Presentation Skills 12 18 5. Reading Skills 09 18 6. Writing Skills 09 17 7. Grammar and Vocabulary 06 15 60 100% Total © CHARUSAT 2012 Page 47 of 240 Detailed Syllabus (Theory and Practical): No. 1 Contact Unit details Hours An Introduction to Communication and Key Concepts in 08 Communication: 2 - An Introduction to Communication - Basic terms, concepts, and contexts of communication - Importance, Types and Principles of Communication 08 Major Communication Techniques and Styles: - Introduction to Communication styles and techniques - Assertive, Aggressive, Passive and Passive - Aggressive Communication 3 4 Working with different Styles 08 Listening Skills: - Introduction to Listening - Purpose and Types of Listening - Traits of a good listener - Barriers to effective listening and Tips for effective listening 12 Presentation Skills: - Introduction to Presentation and its importance - Modes, Means and Purposes of Presentation - Defining purpose, analyzing audience and organizing the contents 5 Visual aids and nuances of delivery 09 Reading Skills: - An Introduction to Reading and Comprehension - Types and Techniques - Skimming and Scanning of Reading - Inferencing in Reading - Reading data in various forms © CHARUSAT 2012 Page 48 of 240 No. 6 Contact Unit details Hours 09 Writing Skills: - Introduction to Writing and Importance of effective writing - Paragraph Development, Coherence – Topic Sentence, Supporting Sentence, Authentication, and Examples - Letter Writing and Resume Making - Drafting…press notes, memo, circulars, notices, telegrams, agenda, minutes etc 7 06 Grammar and Vocabulary: - Tenses and the Concept of Time - Active and Passive Constructions - Direct – Indirect Speeches - Prepositions and Conditionals - Idioms, Confusables, One-word Substitutes, Synonyms, Antonyms Recommended Study Material: Reference Reading: Krishna Mohan & Meera Developing Communication Skills Banerji Communication Skills for Technical student Farthullah T M Basic Business Communication 10th ed Lesikar R V & Flatley M E Additional Reading: Communication Skills for Engineers Mishra S & Muralikrishna C Written Communication in English Freeman Sardh ABC of Common Grammatical Errors Nigel B. Turton © CHARUSAT 2012 Page 49 of 240 Bachelor of Pharmacy Programme SYLLABI (Semester – 2) CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY © CHARUSAT 2012 Page 50 of 240 HUMAN ANATOMY & PHYSIOLOGY-II (PH106) (Theory and Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the Course: To make students familiar with the principles of human anatomy and physiology as well as basic concepts related to health. Student Learning Outcomes/Objectives: At the end of the course, the student will be able to understand the concept of anatomy and physiology of different organ systems which is a prerequisite for understanding the concepts of pharmacology. Instructional Methods and Pedagogy: Faculty member/s shall explain in a class room using black board and multimedia projector, charts and models of different organ systems. Outline of the Course: No. Unit Minimum No. of Contact Hours Approx. weightage % 1 Haemopoetic system 6 15 2 Cardiovascular system 12 20 3 Respiratory system 5 10 4 Urinary system 4 15 5 Lymph and lymphatic system 3 5 6 Body defense Mechanisms & Immunity 4 10 7 Digestive system 4 10 8 Water & electrolyte balance 3 5 9 Vitamins, Nutrition & Metabolism 2 5 10 Basic concept on Genetic Disorders 2 5 45 100 % Total © CHARUSAT 2012 Page 51 of 240 Detailed Syllabus (Theory): No. Unit details Contact References Hours 1 Haemopoetic system: 6 5, 12 12 5, 3, 12 5 5, 12 4 5, 12 3 5 12 4 5, 12 - Composition and function of blood and its elements. - Their disorders, blood group and their significance. - Mechanism of coagulation, disorder of platelets and coagulation. 2 Cardiovascular system: - Basic anatomy of heart, blood vessels and circulation. - Basic understanding of cardiac cycle, heart sounds and electrocardiogram. - Blood pressure and its regulation. - Brief outline of cardiovascular disorders like hypertension, hypotension, arteriosclerosis, angina, myocardial infarction, congestive cardiac failure and cardiac arrhythmias. 3 Respiratory system: - Anatomy of respiratory organ, function of respiration, mechanism and regulation of respiration, respiratory volumes and vital capacity. 4 Urinary system: - Various parts, structure and function of the kidney and urinary tract. Physiology of urine formation and acidbase balance. Disorders of urinary system. 5 Lymph and lymphatic system: - Composition, formulation and circulation of lymph, disorder of lymph and lymphatic system. Basic physiology and function of spleen. 6 Body defense Mechanisms & Immunity: - Basic principles of immunity, innate immunity, adaptive immunity, immune interactions, immunotherapy, acquired © CHARUSAT 2012 Page 52 of 240 immunity and brief overview of immune system pathology. 7 Digestive system: 4 5, 12 3 13 2 6, 13 2 20 - Gross anatomy of Gastro Intestinal Tract, Functions of its different parts including those of liver, pancreas and gall bladder, various Gastro Intestinal Tracts and their role in absorption and digestion of food. Disorders of digestive system. 8 Water & electrolyte balance: - Brief overview of body fluids & regulation of intracellular fluid composition, extracellular fluid composition, ion concentrations, water content balance. 9 Vitamins, Nutrition & Metabolism: - Brief overview of different Vitamins. - Concept of Body Nutrition, metabolism of carbohydrates, lipid & proteins, metabolic rate. 10 Basic concept on Genetic Disorders: - Introduction to DNA, Chromosomes, Gene mutation - Application of genetics in pharmacy Genetic disorders related to different body system & organs Detailed Syllabus (Practical): No. Aim of the Practical 1 Use & care of Microscope. 2 To find out total W.B.C Count of human blood. 3 To find out Differential W.B.C count of human blood. 4 To find out total R.B.C Count of human blood. 4 To find out Haemoglobin content, oxygen carrying capacity & colour index of human blood. 5 To find out effect of osmotic pressure on R.B.C of human blood. 6 To find out bleeding and clotting time of human blood. © CHARUSAT 2012 Page 53 of 240 No. Aim of the Practical 7 To Study the effect of Posture on Vital Capacity using Spiro meter. 8 To perform biochemical Analysis of Urine. (To find out normal & abnormal Constituents of given urine sample.) 9 To perform biochemical Analysis of Urine. (To find out normal & abnormal Constituents of human urine sample.) 10 Determination of pulse rate, blood pressure, listening to heart sounds with the help of Sphygmomanometer and Stethoscope. 11 To record electrocardiogram (ECG) of a person. 12 To find out urine glucose estimation by use of urine glucose strip ( DIASTIX) 13 To study following systems using charts and models: Cardiovascular system Respiratory system, Urinary system, Digestive system. 14 To study histology of different tissues using permanent slides. Recommended study materials: 1. Fundamentals of anatomy and physiology; Martini F; Prentice hall; 2nd Ed. 1992. 2. Anatomy and physiology; Seeley R R, Stephens T D and Tate P Mosby, St Louis; 3rd Ed.; 1995. 3. Text book of medical physiology; Guyton; W. B. Saunders Co.; Philadelphiea; 8th Ed. 1991. 4. West J. B. Best and Taylor’s physiological basis of medical practice; Williams and Wilkins, Baltimone; 12th Ed.1989. 5. Principles of anatomy and physiology; Tortora G. J. and Anagnodokos, N. P.; Harper and Colling Publishers, New York; 7th Ed. 1992. 6. Human anatomy, physiology and health education; Gandhi, T. P.; B. S. Shah Prakashan, Ahmedabad; 9th Ed. 1998. 7. Preparatory Manual for undergraduates’ physiology; Joshi, Vijaya D.; B. I. Churchill Livingstone; 1995. 8. Human physiology; Chatteerjee, C. C.; Medical Allied Agency Calcutta; 10th Ed.1985. 9. Physiology and anatomy; Clancy, John and MoVicet, A. J.; Edward Arnold; 1995. 10. Human Physiology; Subhash Shalya; C. B. S. Publishers New Delhi; 1st Ed. 1994. 11. Human Anatomy; Chaurasia, B.O; C. B. S. Publishers New Delhi; 3rd Ed. 1994 © CHARUSAT 2012 Page 54 of 240 12. Anatomy and physiology in health and illness; Ross and Wilson’s; Churchill Livingstone; 8th Ed. 1995. 13. Health Education and Community Pharmacy; Parmar N. S; C. B. S. Publishers New Delhi 1995. 14. Practical anatomy Physiology and biochemistry; Goyal R. K.; B. S. Shah Prakashan, Ahemedabad; 1994. 15. A textbook of history; Garg K. et. al; C. B. S. Publishers, New Delhi; 2nd Ed.1991. 16. Text books of histology; Lesson C. R. et. al.; W. B. Saunders Co.5th Ed. 17. Atlas of anatomy; Aqur, Anne M.R.; Williams and Wilkins 9th Ed.1991. 18. A photographic atlas for the anatomy and physiology lab.; Van de Graaff and Crewley, J. L.; Mortan Publishing Co.; 3rd Ed. 1991. 19. A text book of practical physiology; Ghai, C. L.; Jaypee Brothers Medical Publishers (P) Ltd.;4th Ed. 1998.(Practical). 20. Microbiology- An Introduction; Tortora Gerard J; Pearson Edu Asia; 2004. © CHARUSAT 2012 Page 55 of 240 BASIC PHARMACOGNOSY-II (PH107) (Theory & Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the Course: The objective of the course is to provide the knowledge about probable types of adulteration and their detection in herbal drug samples. To introduce the students to phytochemical and Pharmacognostic features of carbohydrate and lipid containing drugs and types of pharmaceutical aids. The students are introduced to the types of phytoconstituents, their physico chemical properties and the methods of their detection. Student Learning Outcomes/Objectives: At the end of the course, the student are expected to • Understand different types of adulteration of crude drugs • Understand different evaluation methods ascertain the presence or absence of adulteration • Recognize the crude drugs mentioned in the course • Learn the pharmacognostic aspects specifically, the sources, the preparation methods and utilization of those substances obtained from the natural sources. • Learn different classes of phytoconstituents along with their exact definition and physico chemical properties and the preliminary chemical tests to detect those from plants/ plant extracts. Instructional Methods and Pedagogy: The lectures will be delivered using • Black board • Over Head Projector • Multimedia projector • Visit of herbal garden © CHARUSAT 2012 Page 56 of 240 Outline of the Course (Theory): No. Unit Minimum No. Approx. of Contact Hours weightage % 1 Quality control of crude drugs. 11 35 % 2 Introduction to the active phytoconstituents. 5 15 % 3 Systematic Pharmacognostic study of the crude 17 30 % drugs. 4 Study of pharmaceutical aids. 7 10 % 5 Study of fibers used in pharmacy. 5 10 % 45 100 % Total Detailed Syllabus (Theory): No. 1 Unit details Quality control of crude drugs: Contact Hours References 11 1,3,4,6,8 5 1,3,4,6,8 17 1,3,4,5, Adulteration of crude drugs and their detection by organoleptic, microscopic, physical, chemical, biological and other physical and chemical methods of evaluation. 2 Introduction to the active phytoconstituents: Introduction to the active constituents of the drugs and their physico-chemical properties. 3 Systamatic and Pharmacognostic study of the crude drugs: 6,8,7,9 (A) Carbohydrates and derived products: Agar, Guargum, Acacia, Honey, Isabgol, Pectin, Starch, Sterculia, Tragacanth and Sodium alginate. (B) Lipids: Beeswax, Olive Oil, Castor oil, Cocoa butter, Cod liver oil, sesame oil, wool fat, Linseed oil, Shark liver oil. 4 Study of pharmaceutical aids like Talc, Diatomite, Kaolin, 7 1,3,4,6,8 5 1,3,4,6,8 Bentonite, Gelatin, and Natural colors. 5 Study of fibers used in pharmacy such as Cotton, Silk, Wool, Nylon, Glass wool, Polyester and Asbestos. © CHARUSAT 2012 Page 57 of 240 Detailed Syllabus (Practical): No. Aim of the Practical 1 Microscopic studies of Ergastic Contents present in the plant cell. 2 Microscopical study of different types of stomata in different leaf samples. 3 Microscopical study of different types of trichomes in different leaf samples. 4 Determination of Stomatal Index of leaf sample. 5 Determination of Vein islet and Vein termination number of leaf sample. 6 Determination of Palisade Ratio of leaf sample. 7 Quantitative estimation of starch grains in given sample of ginger powder by lycopodium spore method. 8 Estimation of total Fibre content in give sample of Cinchona Powder. 9 Morphology and microscopy study of Isabgol seed. 10 Morphology and microscopy study of Linseed. 11 Morphological Studies of Lipid and Carbohydrate containing Drugs. 12 Chemical Tests of Lipids and Carbohydrates. 13 Determination of Acid Value and Saponification Value of given Sample of Oil. 14 Determination of Iodine Value and Peroxide value of given Sample of Oil. Recommended study materials: a) Text books: 1. Pharmacognosy; C. K. Kokate, A. P. Purohit, S. B. Gokhale; Nirali prakashan, Pune; 39th Edition; 2007. 2. Botany for degree students; A. C. Dutta; Calcutta Oxford university press, New Delhi; 15 impressions; 1994. 3. A textbook of Pharmacognosy; Mamta Shah, Urvashi Shah, Sangita Marfatia; Nirav and Roopal Prakashan; 2008-09. 4. Textbook of Pharmacognosy I; S. B. Dhake, Parul B. Patel; Nirav and Roopal Prakashan; 2008-09. 5. Pharmacognosy; J. S. Quadry; B. S. Shah Prakashan, Ahemedabad; 14th edition; 200809. © CHARUSAT 2012 Page 58 of 240 b) Reference books: 6. Pharmacognosy; V. E. Tylar, L. R. Brady, J. E. Habbers; Lea and Febgir Philadelphia; 8th edition; 1981. 7. Pharmacognosy of powdered crude drugs; M. A. Tyenger; Manipal power press; 1st Edition; 1974. 8. Trease and Evan’s Pharmacognosy; W. C. Evans; W. B. Saunders Co., Singapore; 15th Edition; 2008. 9. Text Book Pharmacognosy; T.E. Wallis; CBS Publishers and Distributors, Delhi; 5th Edition; Reprint-2005. © CHARUSAT 2012 Page 59 of 240 PHARMACEUTICAL CHEMISTRY-II (Physical) (PH108) (Theory) Credits: 2 Contact Hours per week: 2 Objective of the course: • The course covers fundamentals of chemistry including solutions, kinetics, equilibria, thermodynamics, chemical catalysis, nuclear chemistry and photochemical reactions. Students learning outcomes/objectives: • By the end of this course, the student should have a good understanding of the history and basic concepts of physical chemistry • Students should understand principles of states of matter, aqueous solutions, acidbase chemistry, thermodynamics, chemical catalysis and their applications. Instructional methods and pedagogy: • Using blackboard and one-way communication from a teacher t o a student. • Using an overhead and LCD projector Outline of the course (Theory): Minimum No. No. Unit of Contact Hours Approx. Weightage % 1 The Liquid State 04 20 2 Nuclear and Radiopharmaceutical Chemistry 06 10 3 Photochemistry 03 10 4 Electrolytes 05 15 5 Solutions 04 15 6 Chemical Catalysis 02 10 7 Thermodynamics 06 20 30 100 % Total © CHARUSAT 2012 Page 60 of 240 Detailed syllabus (Theory): No. 1 Unit details The Liquid State Contact Hours References 04 4, 6,7 06 2,4,5,6,7 03 4,5,6,7 05 2,3 04 4,5,6,7 02 4,5,6,7 06 4,5,6,7 Physical properties and applications of surface tension, Parachor, Viscosity, Refractive index, Optical rotation, Dipole moment of the chemical constituents in pharmacy. 2 Nuclear and Radiopharmaceutical Chemistry Structure of nucleus, Methods of nuclear radiation measurement, Nuclear reaction, Fusion and fission, Radiation dosimetry, Radio opaque contrast medium, (Therapeutic and diagnostic applications of radio pharmaceuticals). Basic principals of Radioactivity Rays and Measurement of Radioactivity, Applications. 3 Photochemistry Consequences of lights adsorption, Jablonski diagram, Quantum efficiency, Photosensitization reactions. 4 Electrolytes Extra and intracellular ions: Chlorides, Phosphate, Bicarbonate, Sodium, Potassium, Calcium, Magnesium. Electrolytes used for replacement therapy, Physiological acid base balance. 5 Solutions Ideal and real solutions, Solutions of gases in liquids, Colligative properties, Partition co-efficient, Conductance and its measurement, Debye-Huckel theory. 6 Chemical Catalysis Characteristics of homogeneous and heterogeneous catalysts, Acid-base catalysis. 7 Thermodynamics Basic principles, First, Second and Third laws, Zeroth Law, Absolute temperature scale, Thermochemical equations, Phase equilibria and Phase rule, One and two component systems. © CHARUSAT 2012 Page 61 of 240 Recommended study material: 1. Indian Pharmacopoeia; Government of India: New Delhi, 2007 2. “Medicinal and Pharmaceutical Chemistry” Inorganic; J. H. Block, E. B. Roche; Varghese Publication; Indian edition. 3. “Text Book of Pharmaceutical Chemistry” Revised by L. M. Atherden, Bentley & Driver’s ; Oxford Medical Publications; 8th edition. 4. “Essential of Physical Chemistry”; B.S. Bhal, G.D. Tuli and Arun Bhal, S. Chand and Company Ltd. 23rd Edition,1996. 5. “The Science and Practice of Pharmacy”; Remington, Lipincott, William and Wilkins; 20th edition. 6. “Advanced Physical Chemistry”, Gurdeep Raj, Goel Publishing House; 20th Edition, 1996. 7. “Textbook of physical chemistry” Soni P. L., Sultan Chand and Sons. 8. “Text book of Physical Chemistry”; Semuel Glasstone, Macmillan India Limited, 2nd Ed. 1995. 9. “Elements of physical Chemistry”; Peter Atkins, Julio De Paula, Oxford University Press, 4th Ed. 2007. © CHARUSAT 2012 Page 62 of 240 PHARMACEUTICAL ENGINEERING-II (PH109) (Theory & Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the course: • To study basic process which are used in different stage during preparation of raw materials in pharmaceutical industries. • Subject gives the guideline for clarification and purification of solid and liquid raw materials. Students learning outcomes/objectives: • By the end of this course, the student should have a good understanding of the basic concepts of clarification and purification of solid and liquid raw materials in pharmacy. • Students should be able to know the appropriate instrumental requirement for different types of unit operations used in pharmaceutical industry. Instructional methods and pedagogy: The lectures will be delivered using • Black board, • Over Head Projector • Multimedia projector Outline of the course (Theory): No. Unit Minimum no. Approx. of Contact Weightage Hours. % 1 Filtration 08 18 2 Centrifugation 05 10 3 Evaporation 08 18 4 Distillation 08 18 5 Drying 08 18 6 HVAC 08 18 45 100 % (Humidity Ventilation and Air Conditioning) Total © CHARUSAT 2012 Page 63 of 240 Detailed syllabus (Theory): No. 1 Unit details Filtration: Theory and mechanism of filtration process, factors Contact Hours Reference 8 2,5,9 5 1,2,8 8 2,7,8,9 8 2,8,9 8 2,5,8 affecting rate of filtration, filter media, filter aids, types of filters, operation of filters, industrial filters-leaf filter, filter press, rotary filter, edge filters, cartridge filters, membrane filters, optimum cleaning cycle in batch filters, etc. Mathematical problems on filtration. 2 Centrifugation: Principle and theory of centrifugation, industrial centrifuges-perforated basket centrifuge, sedimentation type centrifuge, continuous centrifuges etc. Applications in pharmacy. 3 Evaporation: Basic concept of phase equilibria, factors affecting evaporation, heat transfer in evaporators, Duhring’s Rule and Raoult’s law, evaporators- natural circulation forced circulation & film evaporators, single effect and multiple effect evaporators, mathematic problems. 4 Distillation: Physical concepts, Vapor liquid equilibrium relationship, volatility & relative volatility, simple steam and flash distillations, batch and continuous distillation, rectification, distillation columns (packed, plate) and their efficiency, McCabe Thiele method for calculation of number of theoretical plates, azeotropic, molecular & steam distillation, mathematical problems. 5 Drying: Principle, Moisture content, loss on drying, theory & mechanism of drying, drying rate and time calculations, classification of dryers, factors affecting selection of dryers, dryers used in pharmaceutical industries - tray, vacuum, fluidized bed, spray, freeze, tunnel, Microwave, Infra Red(IR), rotary dryers. Mathematical problems on drying. © CHARUSAT 2012 Page 64 of 240 No. 6 Unit details HVAC (Humidity Ventilation and Air Conditioning): Contact Hours Reference 8 2,6,8 Definitions of various terms, wet bulb and adiabatic saturation temperatures, psychrometric chart and determination of humidity, equipments for humidification and de-humidification operations, applications of humidity control in various pharmaceutical processes. Basic concepts and types of refrigeration cycles, air conditioning, applications in pharmacy. Design of HVAC systems. Detailed syllabus (Practical): No. Aim of Practical 1 To determine specific cake resistance and resistance offered by filter media on rate of filtration. 2 To study the effect of temperature on rate of filtration 3 To study the effect of filter aids on rate of filtration 4 To find out optimum concentration of filter aid. 5 To study effect of viscosity on rate of filtration. 6 Demonstration of laboratory centrifuge machine. 7 To study effect of temperature on evaporation. 8 To study effect of Surface area on evaporation. 9 To study effect of viscosity on evaporation. 10 To find out EMC, CMC, FMC of given powder. 11 To study effect of surface area on drying. 12 To purify the turpentine oil and find out its molecular weight. 13 To study formation of azeotropic mixture and to separate it using third liquid. 14 15 Calculation of humidity, %RH, Humid heat, Humid Volume by dry bulb and wet bulb temperature. To verify Rayleigh’s equation for differential distillation of acetic acid and water. © CHARUSAT 2012 Page 65 of 240 Recommended study material: 1. Perry’s Chemical Engineer’s Handbook; Robert H Perry, Green D.W., Maloney J.O.; McGraw Hill Inc., New York; 7th Edition, 1998. 2. Copper and Gun’s Tutorial Pharmacy; S. J. Carter; CBS Publication & Distribution, New Delhi; 2004 3. Pharmaceutical Engineering; K. Sambamurthy; New Age International Ltd., New Delhi 2002. 4. Pharmaceutic the Science of Dosage Form Design; M.E. Aulton; Churchill Livingstone, London; 2002. 5. The Theory & Practice of Industrial Pharmacy; Lachman L., Lieberman H.A., Kanjig J.L., Varghese Publishing House, Bombay; 3rd edition; 1991. 6. Remington: The Science and Practice of Pharmacy; Gennaro A.R.; Lippincott Williams &Wilkins, Philadelphia; 2004. 7. Pharmaceutics II (Unit Operations); Jani G. K.; B. S. Shah Prakashan, Ahmedabad; 2002 8. Pharmaceutical Engineering : Principles and Practice; Subramanyam C.V.S., Thimma J, Suresh S.S.; Vallabh Prakashan, Delhi; 2004. 9. Benthley`s Textbook of Pharmaceutics; Rawlins E A; AITBS Pub & Dist Delhi; 2004. © CHARUSAT 2012 Page 66 of 240 DISPENSING PHARMACY (PH110) (Theory & Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the course: • To study basic process which are used in different stage during preparation of pharmaceutical formulation. • Subject gives the guideline for calculation of formulas, labeling, and packing of different types of pharmaceutical products. Students learning outcomes/objectives: • By the end of this course, the student should have a good understanding of the basic concepts of formulation, labeling, packing of different types of pharmaceutical dosage forms. • Students should be able to know the appropriate dose calculation and drug for patient Instructional methods and pedagogy: The lectures will be delivered using • Black board, • Over Head Projector • Multimedia projector Outline of the course (Theory): No. Unit Minimum No. Approx of Contact Weightage % Hours 1 Definition and scope 2 5 2 The prescription 4 10 2 Dispensing techniques 4 10 3 Pharmaceutical calculations 8 15 4 Principles involved and procedures adopted in dispensing of various pharmaceutical 40 16 preparations 5 Incompatibilities Total © CHARUSAT 2012 11 20 45 100 % Page 67 of 240 Detailed syllabus (Theory): No. Unit details 1 Definition and scope 2 The prescription: Handling of prescription, sources of errors in prescription, care required in dispensing Contact Hours Reference 2 2 4 2 4 2 8 2, 3 16 2,4,6 11 2,8 procedures including labeling of dispensed products. 3 Dispensing techniques: Compounding and dispensing procedures, packaging, storage and stability of medicines, labelling of dispensed products 4 Pharmaceutical calculations: Posoloy: Calculations of doses for infants, adults & elderly patients, enlarging and reducing recipes, percentage solutions, allegation, alcohol dilution, proof spirit, isotonic solutions, displacements value etc. 5 Principles involved and procedures adopted in dispensing of: Liquid Products (Mixtures, solutions, emulsions, suspensions) external preparations, suppositories & pessaries, powders and granules, oral unit dosage forms, inhalations. 6 Incompatibilities: Physical, chemical and therapeutic incompatibilities observed in prescriptions of above products: (a) Identifications and correction of incompatibilities. (b) Inorganic incompatibilities including incomp. of metals and their salts, non metals, acids, alkalis. (c) Organic incompatibilities: Purine bases, alkaloids, pyrazolone derivatives, amino acids, quaternary ammonium compounds, carbohydrates, glycosides, anesthetics, dyes, surface active agents. © CHARUSAT 2012 Page 68 of 240 Detailed syllabus (Practical): No. Aim of Practical 1 Introduction - General dispensing procedure - Weights and measures - Fundamental operations in Dispensing - Household measurements - Study of prescription in general 2 Preparation, labeling and packing of Oral & external solutions 3 Preparation, labeling and packing of solutions used for oral cavities 4 Preparation, labeling and packing of solutions used for nose, ear, eye, rectum, vagina etc. 5 Preparation, labeling and packing of suspensions containing diffusible Solids, in-diffusible solids, poorly wettable solids. 6 Preparation, labeling and packing of suspensions containing precipitate forming liquids, suspensions prepared by chemical reaction etc. 7 Preparation, labeling packing of emulsion containing fixed oil, volatile oil, both types of oil, mineral oil etc. 8 Preparation, labeling & packing of external emulsions. 9 Preparation, labeling and packing of ointments containing Hydrocarbon Base, water miscible base, absorption base and water soluble base. 10 Preparation labeling & packing of Non-staining ointments, paste, gel, cold cream, vanishing cream etc. 11 a) To determine the mould capacity b) To determine the Displacement value c) Preparation, labeling and packing of Coca butter Suppositories containing soluble, insoluble, semisolid substances etc. 12 Preparation, labeling & packing of suppositories containing gelatoglycein, Soap glycerin and macrogol base. 13 Preparation, labeling and packing of Bulk powders, Divided powders etc. © CHARUSAT 2012 Page 69 of 240 No. Aim of Practical 14 a) Preparation, labeling and packing of effervescent granules b) Preparation of Tablet triturates by moulding c) Preparation of lozenges 15 Evaluating given prescriptions for drug interactions Recommended study material: 1. Pharmaceutical Practice; Diana M. Collett, Michale E.Aulton; ELBS Pubilshers. 2. Dispensing for pharmaceutical students” by Copper and Gunn by S.J.Carter, 12th Edn. CBS Publishers. 3. “Pharmaceutical Calculations” by Mitchell J. Stklosa & Howard C.Ansel by Lippincott Williams & Wilkins. 4. “Pharmaceutical Dosage forms and Drug delivery systems” by Howard C. Ansel by Lippincott Williams & Wilkins. 5. “Pharmaceutical Practice” Edited by A.J. Winfield & R.M.E. Richardes. 6. “Remington: The Science and Practice of Pharmacy” Latest edn. by Mack Publishing Company. 7. Pharmacy Practice by Stone and Cartis. 8. Copper and Gun’s Tutorial Pharmacy by S.J.Carter. © CHARUSAT 2012 Page 70 of 240 ADVANCED MATHEMATICS (MA141) (Theory) Credits: 3 (Theory) Contact Hours per week: 3(Theory) Objective of the Course: To introduce the basic concepts of Mathematics to students passing HSC with B-group. Pre-requisite: No additional Pre-requisite required. Methodology: The emphasis during Lecture sessions will be on Understanding of Concepts rather than on complexities of Computational Techniques. Stress is also given on Visual perception through Mathematical Software. Relevant Illustrations will be provided from the Real World processes. Sufficient home assignments will be given to the students which will test their fundamentals and ability to relate Mathematical concepts with reality. Outline of the Course: No. Minimum No. of Approx. Contact Hours Weightage % Unit 1 Higher order derivatives and applications 6 14 2 8 17 3 Mean value theorems and expansion of functions Laplace Transforms 6 14 4 Ordinary Differential Equations 6 14 5 Linear Differential Equations 8 17 6 Mathematical modeling 11 24 45 100 Total © CHARUSAT 2012 Page 71 of 240 Detailed Syllabus: 1 Contact Unit details No. hours 6 Higher order derivatives and applications - Real world problems involving concepts of first and higher order derivatives - successive differentiation - nth derivative of elementary functions viz., rational, logarithmic, trigonometric, exponential and hyperbolic - Leibnitz rule for the nth order derivatives of product of two functions. 2 8 Mean value theorems and expansion of functions: - Lagrange’s and Cauchy mean value theorems - expansion of functions - Maclaurin’s & Taylor’s series expansions 3 6 Laplace Transforms: - Laplace transforms of elementary functions - Inverse Laplace transforms - linearity property - first and second shifting theorem - Laplace transforms of derivative and integrals - applications of Laplace transforms in solving ordinary differential equations 4 6 Ordinary Differential Equations: - Modelling of real world problems in terms of first order ODE - Initial Value problems - Concept of general and particular solutions - Existence and Uniqueness solutions by illustrations - linear, Bernoulli and Exact differential equations © CHARUSAT 2012 Page 72 of 240 5 Contact Unit details No. hours 8 Linear Differential Equations: - Model of real world problems of higher order LDE - Complementary function and particular integral - LDE of higher order with constant coefficients - Methods for finding particular integrals viz., variation of parameters and undetermined coefficients - LDE of higher order with variable coefficients viz., Cauchy’s and Legendre’s homogeneous linear differential equations - System of two first order linear differential equations. 6 11 Mathematical modeling: - Construction of mathematical models - growth of bacteria - rate of decay - Newton’s law of cooling, - diffusion and fick’s law of diffusion - effects of immigration and immigration on population size, - spread of infectious diseases, - model for diffusion of glucose, Recommended study materials: 1. Calculus and Analytical Geometry; Thomas G. B. and R. L. Finney; Addision Wesley; 9th Ed., 1996. 2. Advanced Engineering Mathematics, Erwin Kreyszig; Jhon Wiley & Sons, India, 8th Ed., 1999 3. Calculus Early Transcendental; Stewart James; Thomson India, 5th Ed., 2007 4. Advanced Engineering Mathematics; Wylie & Barrett; Mc graw Hill publication. 5. Advanced Engineering Mathematics; Greenberg M D; Pearson Educat, 2nd edition. © CHARUSAT 2012 Page 73 of 240 COMMUNICATION SKILLS-II (EN104) (Theory and Practical) Credits: 1 (Theory) Contact Hours per week: 1 (Theory) : 1.5 (Practical) : 3 (Practical) Objectives of the Course: • To sharpen Communication Skills of the students with reference to Organizational Structure, • To expose them to the modern modes of communication, and • To prepare the students for Campus Interviews Instructional Method and Pedagogy: • Lectures will be taken in class room and practicals will be conducted in the language lab with the use of multi-media presentations / black board work and mix of both. • Some assignments and Presentation Tasks will be given. • Students will also be engaged in interpersonal communication activities such as group discussion, role plays, simulations, just a minute sessions, etc. • Mock Interviews will be conducted for practice Outline of the course (Theory and Practical): Minimum No. No. Unit contact of hours 1. The Internet, Communication, and Contemporary Approx. Weightage % 07 8 07 9 Society 2. Advanced Interpersonal and Organizational Communication 3. Group Communication and Group Dynamics 05 9 4. Advanced Report Writing 07 16 5. Effective Presentation Strategies 10 16 6. Group Discussion 08 16 7. Interview Skills 08 15 8. Applying 08 11 60 100 % Communication to Internships in Organizations Total © CHARUSAT 2012 Page 74 of 240 Detailed Syllabus (Theory and Practical): No. 1 Contact Unit details Hours The Internet, Communication, and Contemporary Society: 07 An Introduction to Modern Day Communication Theories of group and community communication Understanding Internet communication and its social implications Basic terms, concepts, and contexts of Internet Communication 2 Advanced Interpersonal and Organizational Communication : 07 Introduction to Interpersonal and Organizational Communication Levels of Communication Essentials of Organizational Communication 3 Group Communication and Group Dynamics : 05 Introduction to Group Communication Introduction to Group Dynamics Communication Networks within and outside the Groups Social & Behavioural Sciences and Group Communication 4 Advanced Report Writing: 07 An introduction to Report Writing Types of Reports Organizing Information & Collaborative Writing Drafting and Revising Documents for Grammar, Mechanics and Coherence Designing effective documents and visuals 5 Effective Presentation Strategies: 10 Why and How in Presentation Presentation Mechanics and Presentation Process Managing Yourself during Q and A Session Fundamentals of Persuasions © CHARUSAT 2012 Page 75 of 240 No. 6 Unit details Contact Hours Group Discussion: 08 Introduction to Group discussions Group Discussion as a part of the selection process Guidelines for group discussion Roles and functions in group discussion 7 Interviews: 08 Introduction to Interviews General preparations for an interview Types of questions generally asked at the interviews Types of interviews Importance of nonverbal aspects 8 Applying Communication to Internships in Organizations: 08 Communication in Organizations Role of Communication in Organizations Theories of interpersonal communication and organization structures Communication Management in an Organization Recommended Study Material: Reference reading: 1. Effective English for Engineers and Technologists; Dr. Rai Ajay. 2. Spoken English 2nd Edition; Sreevalsan M. C. 3. English for Technical Communication Volume 2&2 Combined; Laxminarayan R. K. Additional Reading: 4. English for Technical Communication Volume 2&2 Combined; Laxminarayan R. K. 5. Longman Dictionary of Common Errors; Turton N. D. 6. Learning to Communicate: A Resource Book for Scientists and Technologists English 1 & 2; Chellammal V. © CHARUSAT 2012 Page 76 of 240 ENGINEERING GRAPHICS (PH111) (Practical) Credits: 1.5 (Practical) Contact Hours per week: 3 (Practical) Objective of the course: • To study basic fundamental of engineering drawing. • To study the making and reading of drawings Students learning outcomes/objectives: • By the end of this course, the student should have a good understanding of the basic concepts of engineering drawing. • Students should gain knowledge of the appropriate operating procedure of engineering drawing. Instructional methods and pedagogy: The lectures will be delivered using • Black board, • Over Head Projector • Multimedia projector Detailed syllabus (Practical): Sr. No. 01 List of Practical Introduction to Engineering Graphics Instrument used in Engineering Drawing 02 Lay out of Drawing Sheet and Line, Letters and Numbers 03 Scale and Dimensions 04 05 Introduction of Orthographic Projections Principle of first and third angle projection with example Introduction of Isometric Projections Isometric view and Isometric projection with example 06 Sectioning 07 Overview of computer aided drafting and 3D Modeling © CHARUSAT 2012 Page 77 of 240 Recommended study material: 15. Engineering Drawing; N. D. Bhatt; Charotar publishing house, Anand; 2006 16. Engineering Drawing and Graphics; K Venugopal; New Age International, New Delhi; 4th Edition; 2003. 17. Machine Drawing for Pharmacy Students; K.Sampath, Birla Publications Pvt. Ltd., New Delhi; 2nd Edition; 2008. © CHARUSAT 2012 Page 78 of 240 Bachelor of Pharmacy Programme SYLLABI (Semester – 3) CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY © CHARUSAT 2012 Page 79 of 240 PATHOPHYSIOLOGY (PH201) (Theory) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) Objective of the Course: To make students familiar with the principles of Pathophysiology as well as basic concepts of pathogenesis related to Diseases. Student Learning Outcomes / Objectives: At the end of the course, the student will be able to understand the concept of Pathophysiology which is a prerequisite for understanding the concepts of pharmacology. In addition they will be able to know about pathogenesis & alteration of normal physiology of common diseases. Instructional Methods and Pedagogy: Faculty member/s shall explain in a class room using black board and multimedia projector. Outline of the Course (Theory): Sr. No. Unit Minimum No. of Contact Hours Approx. Weightage % 1 Basic concepts of Pathophysiology. 1 2 2 Basic Principles of cell injury and adaptation 3 7 3 Inflammation 6 13 4 Pathology of Tissue Repair Process 3 7 5 Immunological Disorders 3 7 6 Pathophysiology of common diseases of following organ system: • Cardiovascular disorders • Endocrine disorders • Gastrointestinal disorders • Respiratory disorders • Central nervous system • Hematological disorders • Communicable diseases Total 29 64 45 100% © CHARUSAT 2012 Page 80 of 240 Detailed syllabus (Theory): Sr. No. Name of Chapter 1 Basic concepts of Pathophysiology 2 Basic Principles of cell injury and adaptation 3 Inflammation: Definition, types and etiology of inflammation 4 Pathogenesis of acute and chronic inflammation. Pathology of Tissue Repair Process 5 Immunological Disorders: • 6 Hypersensitivity: Definition, classification with examples • Autoimmunity: Definition, classification and general mechanism of Autoimmune diseases Pathophysiology of common diseases/ disorders: • References Hrs. required 1,2,3,12 1 3,13 3 3,6,9,11,12 6 3,12,15 3 3,6,9,12,11 3 29 6 Cardiovascular diseases / disorders- Hypertension, Angina Pectoris , Myocardial Infarction, Congestive • Heart failure, Cardiac arrhythmias, Atherosclerosis 3,4,5,6,7,8,9, (CAD), Stroke 10,11,12,13,14 4 Endocrine disorders- Diabetes Mellitus, Thyroid & Parathyroid diseases, Adrenal gland diseases • 3 Gastrointestinal disorders- Peptic ulcer disease, Inflammatory Bowel disease, Cirrhosis • 3 Respiratory disorders- Bronchial asthma, Chronic Obstructive Pulmonary Disease • 5 Central nervous system diseases / disordersEpilepsy, Parkinsonism, Schizophrenia, Depression, Migraine • Hematological disorders- Anemia, Leukemia • Communicable diseases :AIDS, Leprosy, Malaria, 4 4 Tuberculosis, Enteric fever,Hepatitis. © CHARUSAT 2012 Page 81 of 240 Recommended study materials: 1. Focus on Pathophysiology, 9th edition, 1999, Barbara A. Bullock and Reet L. Henze Lippincott Williams & wilkins, Philadelphia. 2. Basic Pathophysiology: A conceptual approach, 1979, B.Broer & shekleton C.V. (Mosby Company) 3. Robbin’s Pathologic Basis of Disease, 6th edition, 1999, Cotran R.S., Kumar V and Collins T. W.B.Saunders, Philadelphia 4. Principles of Internal Medicine Vol. I & II ed. By Harrison. 5. The Merck Manual of Diagnosis and Therapy. 17th Ed. 1999-2004. Edited by Mark H. Beers and Robert Berkow. Published by: Merck & Co.Inc., USA. 6. Pathophysiology: P Maurice A. Mufson. 2nd edition, August 2001, McGraw-Hill companies. 7. Clinical Pharmacy & Therapeutics, 2nd edition, Roger Walker; Churchill Livingstone Publication. 8. Pathology and Therapeutics for pharmacists: A basis for clinical pharmacy practice, Green and Harris, Chapman and Hall publication. 9. Pharmacotherapy : A pathophysiologic approach – Joseph T. Dipiro et. al. Appleton & Lange. 10. Stefan Silbemagi, Florian Lang. Color Atlas of Pathophysiology. 1st Ed., June 2000, Thieme Medical Publishers. 11. Sylvia A. Price, Lorraine M. Wilson et al. Pathophysiology: Clinical Concepts of Disease Processes.6th Edition,Oct.2002, Elsevier Science Publishers. 12. Pathophysiology-Lippincott’s Review Series 2nd Edition, Feb 1999. Ed.Catherine Paradiso. 13. Clinical Pharmacy and Therapeutics – Eric T. Herfindal, Williams and Wilkins Publication. 14. Gorgon C. Cook& Alimuddin Zumla, Manson’s Tropical Diseases, twenty first edition, © CHARUSAT 2012 Page 82 of 240 PHARMACOGNOSY AND PHYTOCHEMISTRY-I (PH202) (Theory & Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the Course: To make students familiar with Pharmacognostic study of tannin, resin and volatile oil containing crude drugs, utilized as medicine. Student Learning Outcomes / Objectives: The students are expected to • Learn the pharmacognostic aspects specifically, the sources, the preparation methods and utilization of tannin, resin and volatile oil containing drugs. • Understand basic idea of extraction, isolation and separation of active phytoconstituents from medicinal plants • Understand concept of phytochemical screening of the phytoconstituents obtained from the natural sources. Instructional Methods and Pedagogy: The faculty shall explain the lectures • using black board, • using Over Head Projector, Multimedia projector. • through visit of herbal garden © CHARUSAT 2012 Page 83 of 240 Outline of the Course (Theory): No. Unit 1. Study of drugs containing resins combinations Minimum No. of Contact Hours 12 2. Study of tannins and tannin containing drugs 5 15 3. Study of Volatile oil containing drugs 16 45 4. Basic idea of extraction, isolation and separation of active 12 20 45 100% References Minimum No. of Contact Hours constituents from medicinal plants and Phytochemical Screening Total Approx. weightage % 20 Detailed syllabus (Theory): No. Unit 1. Study of drugs containing resins combinations: Introduction, classification, general properties, chemical tests of resins. Pharmacognostic Studies of the following resin containing 1,2,3,4, drugs: Colophony, Podophyllum, Jalap, Cannabis, Capsicum, 5,6,7,12 12 myrrh, Asafoetida, balsam of Tolu, balsam of Peru, Benzoin, turmeric and Ginger. 2. Study of tannins and tannin containing drugs: Introduction, classification, general properties, chemical tests. Drugs: Black catechu, pale catechu and Myrobalans. 3. 1,2,3,4, 5,6,7,12 5 Study of Volatile oil containing drugs: Introduction, classification, general properties, chemical tests and General methods of obtaining volatile oils from plants. Pharmacognostic Studies of the following drugs, containing volatile oils: Mentha, Coriander, Caraway, Dill, Fennel, Cinnamon, 1,2,3,4,5, 6,7,8,9,12 Lemon peel, Orange peel, Lemon grass, Clove, Nutmeg, Eucalyptus, Chenopodium, Cardamom, Valerian, Sandalwood. © CHARUSAT 2012 Page 84 of 240 16 4. Basic idea of extraction, isolation and separation of active constituents from medicinal plants and Phytochemical Screening: Basic principle of extraction. The factors which may affect the extraction process. Different types of extracts and their 1,2,3,4,5, preparations. The comparative studies of different methods 6,7,10,11,12 12 employed for extraction of phytoconstituents. Phyto chemical Screening of alkaloids, saponins, cardenolides, bufadienolides, flavonoids, tannins, anthraquinones, cyanogenetic glycosides and amino acids in different extracts. Detailed Syllabus (Practical): No. Aim of the Practical 1 Pharmacognostic study of Coriander fruit and histological assessment of the powdered drug. 2 Pharmacognostic study of Fennel fruit and histological assessment of the powdered drug. 3 Pharmacognostic study of Cinnamon bark and histological assessment of the powdered drug. 4 Pharmacognostic study of Clove flower bud and histological assessment of the powdered drug. 5 Pharmacognostic study of Eucalyptus leaf and histological assessment of the powdered drug. 6 Pharmacognostic study of Cardamom seeds and histological assessment of the powdered drug. 7 Pharmacognostic study of Mentha leaf and histological assessment of the powdered drug. 8 Morphological Evaluation of the Tannin and Resin containing drugs. 9 Chemical Tests for Tannins and Resins. 10 Isolation of volatile oil. 11 Successive solvent extraction and detection of phytoconstituents. 12 Preparation of extracts by different methods and determine the extractive values. © CHARUSAT 2012 Page 85 of 240 Recommended study materials: 1. Pharmacognosy: C.K.Kokate, A.P.Purohit, S.B.Gokhale, Nirali prakashan, Pune, 39th Edition, 2007. 2. Pharmacognosy and pharmacobiotechnology, Ashutosh Kar, New Age International (P) Ltd, Publishers, 2nd edition 2007. 3. A Text Book of Pharmacognosy: C. S. Shah, J. S. Quadry, B. S. Shah Prakashan, Ahemedabad, 8th edition, 1990 4. Trease and Evan’s Pharmacognosy: W. C. Evans, W.B.Saunders Co., Singapore, 15th Edition 2008. 5. Text Book Pharmacognosy: T.E. Wallis, CBS Publishers and Distributors Delhi- 5th Edition, Reprint, 1997. 6. Pharmacognosy and Phytochemistry, Part I and II, Vinod D. Rangari, Carrier Publications, 1st Edition, Reprint, 2007. 7. Pharmacognosy: V. E. Tylar, L. R. Brady, J. E. Habbers, Lea and Febgir Philadelphia, 8th Edition, 1981. 8. Cultivation and Utilization of Aromatic Plants, Handa S.S. and Kaul M.K., Regional Research Laboraotry, Jammu, 1st Edition, 1997. 9. Pharmacognosy of powdered crude drugs: M. A. Iyenger, Manipal Power Press, 1st Edition, 1974. 10. Mukherji P. K., Quality Control of Herbal Drugs, Business Horizon Pharma. Publishers, 1st Edition, 2002. 11. Herbal drug technology, S. S. Agrawal and M. Paridhavi, Univeristies Press, 1st Edition, 2007. 12. Essentials of Pharmacognosy, S. H. Ansari, Birla Publications Pvt. Ltd., 1st edition, 2005-2006. 13. Microscopic profile of powdered drugs used in Indian systems of medicine, Malti G. Chauhan and Pillai A.P.G., volume 1, Leaf drugs, (2005), Gujarat Ayurved University, Jamnagar. 14. Microscopic profile of powdered drugs used in Indian systems of medicine, Malti G. Chauhan and Pillai A.P.G., volume 2, bark drugs, (2007), Gujarat Ayurved University, Jamnagar © CHARUSAT 2012 Page 86 of 240 ORGANIC CHEMISTRY-I (PH203) (Theory & Practical) Credit: 3 (Theory) Contact hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the course: • The course is designed to make students familiar with the principles of organic chemistry as applied to pharmaceuticals and to study organic compounds used as pharmaceutical aids, therapeutic agents and diagnostic agents. Students learning outcomes/objectives: • The course will help the student to have a good understanding of the history and basic concepts of organic chemistry. • Students should be able to describe in detail synthetic approaches as well as mechanisms of action of some important organic base therapeutic and diagnostic agents. • The course may help the students in understanding rational approaches towards the design of important therapeutic agents and their biological implications. Instructional methods and pedagogy: • The faculty shall explain the lectures using black board, Over Head Projector or Multimedia projector. Outline of the Course (Theory): Sr. No. Unit Minimum Number of Contact Hours Approx. Weightage % 04 9 Empirical Formula, Molecular Formula, Determination of 1 molecular masses 2 Structure of Organic Molecule 04 9 3 Factors affecting electron availability 04 9 4 IUPAC Nomenclature of organic compounds. 03 7 04 9 Structure, Nomenclature, preparation, physicochemical 5 properties and reaction of Alkanes, Alkenes and Alkynes © CHARUSAT 2012 Page 87 of 240 6 Nucleophilic substitution at saturated and aryl carbon atom. 08 17 7 Elimination reactions 03 7 8 Stereochemistry 08 17 07 16 45 100% Structure, 9 Nomenclature, physicochemical properties, preparation and reaction of: cyccloalkanes, Dienes, Alkyl halides, Alcohols. Ethers, Epoxides. Total Detailed syllabus (Theory): Sr. No. 1 Unit Empirical Formula, Molecular Formula, Determination of molecular References 1,2 Hrs. required 04 1,2,5,6 04 1,2,5,6 04 1,2,5,6 03 masses - Victor Meyer's Method, Elemental Estimation Techniques (C, H, O, N and X) Liebig's method, Dumas' method, Kjeldahl's method, and Carius method 2 Structure of Organic Molecule a. Atomic Orbitals, b. Hybridization, c. Sigma and Pi bonds, d. Intermolecular forces and related properties, e. Conjugation, f. Bond length and bond energies g. Polarity of Bonds and Molecules 3 Factors affecting electron availability a. Inductive effects, b. Resonance effects, c. Hyper conjugation, d. Steric effects, e. Application of these factors on the strength of acids and bases Bond length, f. Tautomerism 4 IUPAC Nomenclature of organic compounds. © CHARUSAT 2012 Page 88 of 240 5 Structure, Nomenclature, preparation, physicochemical properties 1, 2, 3 04 1,2,5,6 08 1,2,5,6 03 1,2,5,6 08 1,2,5,6 07 and reaction of Alkanes, Alkenes and Alkynes 6 Nucleophilic substitution at saturated and aryl carbon atom. a. Relation between Kinetics and mechanism of SN1 and SN2 reactions b. Sterochemical Implications. c. Factors affecting Nucleophilic substitution reactions I. Effect of Solvent, II. Effect of Structure, III. Effect of Nucleophile, IV. Effect of leaving group d. Application of these in preparation and reactions of alkyl halides, alcohols, epoxides e. Nucleophilic substitutions at aryl carbon atom 7 Elimination reactions a. Elimination reaction & Factors affecting it b. E1, E2 and E1 (cb) Mechanism. c. Orientation in E1 and E2 reactions (Saytzaff and Hoffmann elimination). d. Elimination versus substitution. 8 Stereochemistry Chirality, optical activity, stereoisomerism, nomenclature and associated physicochemical properties, specification of configuration, resolution of racemic mixture, reactions involving stereoisomers, stereoselective and stereospecific reactions, conformations – alkanes and cycloalkanes, chiral reagents, stereochemistry of biphenyls, allenes, and spirans – specification of their configuration. 9 Structure, Nomenclature, physicochemical properties, preparation and reaction of: cycloalkanes, Dienes, Alkyl halides, Alcohols. Ethers, Epoxides. © CHARUSAT 2012 Page 89 of 240 Detailed syllabus (Practical): Sr. No. 1 2 Aim of the Practical References Explanation for handling of hazardous chemicals in laboratory. 3,7 Identification of unknown organic compound (acid, base, neutral and phenolic). 3,7 Introduction and detailed demonstration to various synthetic techniques 3 and apparatus used therein. Heating and cooling methods, distillation, reaction work-up, filtration, 3,7 extraction, purification, identification. 4 Introduction to the use of stereo models 3,7 Recommended Study Material: 1. Organic Chemistry by Morrison & Boyd, 6th edition, Pearson Education. 2. Advanced Organic Chemistry: Reaction, Mechanism and Structure by Jerry March 4th edition, A Wiley-Interscience Publication. 3. Vogel’s Text Book of Practical Organic Chemistry- Brian Furniss, Antony Hannaford, Peter Smith, Austrin (Eds), 5th edition, ELBS Publication, Singapore, 1997. 4. Experimental Pharmaceutical Organic Chemistry, A Becnchtop Manual by K. S. Jain, P. B. Miniyar & T. S. Chitre, 2nd Edition Carrier publications,. 5. Organic Chemistry by I. A. Finar 6. A Guidebook to Mechanism in Organic Chemistry by Peter Sykes 7. Organic Chemistry, G. Marc Loudon, 4th Ed., Oxford University Press, 2004. © CHARUSAT 2012 Page 90 of 240 PHARMACEUTICAL ANALYSIS-I (PH204) (Theory & Practical) Credit: 3 (Theory) Contact hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the Course: To make students familiar with the principles of pharmaceutical analysis and its application in pharmacy. Student Learning Outcomes/Objectives: At the end of the course, the student will be able to understand the fundamental concept of pharmaceutical analysis, which is important for qualitative as well as quantitative analysis of drug substances and drug product. Instructional Methods and Pedagogy: Faculty member/s shall explain in a class room using black board and multimedia projector. Outline of the Course (Theory): Sr. No. Minimum No. Unit of Contact Hours Approx. Weightage % 1 Basics of drugs and formulation analysis 5 10 2 Acid Base Titrations 7 17 3 Oxidation- Reduction Titrations 6 14 4 Argentometric or precipitation titrations 6 14 5 Non-aqueous titrations 4 8 6 Complexometric titrations 4 8 7 Gravimetric analysis 7 17 8 Extraction techniques 4 8 9 Miscellaneous Method 2 4 45 100 % Total © CHARUSAT 2012 Page 91 of 240 Detailed syllabus (Theory): Sr. No. 1. References Unit Hrs. Required Basics of drugs and formulation analysis: 1, 2 5 1, 2,3,6 7 2,3,6,7 6 2,7,8 6 weights, balances, importance of analysis, quality control and quality assurance, analytical methods (classification, validation parameters), requirements – chemicals types, purification, checking purity), glasswares (types, calibration, cleaning), sampling techniques, sampling error minimization. Units of concentrations. Errors science, errors minimization. Numerical based in statistics like T-test, F-test, Chi square test. 2 Acid Base Titrations: Relative strength and its effect on titration, common ion effect, pH, Henderson-Hesselbach equation, buffers, neutralization curve, acid bas indicators, theory of indicators, back titrations, biphasic titrations, pharmacopoeial applications, hydrolysis of salts, ionic products of water and law of mass action. 3 Oxidation- Reduction Titrations: Theory of redox titrations, redox indicators, types of redox titrations, iodometry, cerrimetry, mercurymetry, diazotization nitrite titrations, 2,6-dichlorophenol indophenol titrations, titration curve and calculations of potentials during course of titrations. 4 Argentometric or precipitation titrations : Mohr’s, Fajan’s and Volhard’s methods 5 Non-aqueous titrations: 2,4,5,6 4 Nonaqueous solvents, titrants and indicators. Differentiating and leveling solvents. Complexometric titrations: 6 Theory of the titrations, titrant, indicators and pharmacopoeial 7 applications. analysis: Gravimetric 2,8,9 4 2,3,9,10 7 Stability, solubility products, types of precipitations, precipitation techniques, pharmacopoeial applications. © CHARUSAT 2012 Page 92 of 240 8 Extraction techniques : 2,4,6 4 2,7,10 2 Simple extraction, multiple extractions, separation of drugs in multicomponent system. Effect of pH on extractability of drugs, continuous extractions. 9 Miscellaneous Method: Karl Fischer Titration, Gasometry. Detailed syllabus (Practical): Sr. No. 1 (A) Aim of Practical Introduction of titration (B) Introduction to weight and analytical Balance (C) Cleaning and Calibration of laboratory glasswares. 2 (A) (B) 3 References 1,2 To prepare and standardize 0.1 N NaOH using KHP 1,2 To prepare and standardize 0.1 N HCl using anhydrous Na2CO3 To determine %W/V of NaOH and Na2CO3 by IP and BP method in terms of total alkali in given sample. 4 (A) (B) 5 (A) To prepare and standardize HClO4 1,2 To perform the assay of Sodium Benzoate To prepare and standardize 0.1M AgNO3 solution. 1,2 (B) To determine %w/v of NaCl by Mohr’s method 6 To determine %W/V of NaCl by Fajan’s method in given sample solution. To determine %W/V of Ammonium chloride by Volhard’s method in given 7 sample solution. 8(A) To prepare and standardize Disodium EDTA solution. (B) To perform the assay of Ca Gluconate. 9 To determine % w/v Na Oxalate and Oxalic acid in given mixture. 10(A) To determine %W/V of FeSO4 in given sample 11 To determine %W/V of Borax and boric acid (H3BO3) as per IP’96. 12(A) 1,2 1,2 1,2 1,2 To prepare and standardize KMnO4 solution. (B) 1,2 1,2 1,2 To prepare and standardize 0.1N Na2S2O3 solution. (B) To prepare and standardize 0.1N iodine solution. (C) To determine % w/v of I2 and KI in given sample © CHARUSAT 2012 1,2 Page 93 of 240 Recommended Study Material: 1. Pharmacopoeia: USP, B.P., I.P. 2. Quantitative chemical analysis – Vogel A.I, Pearson Education., 5th Edn, 1996. 3. Quantitative Analysis R.A.Day and A.L.Underwood Prentice Hall of India, 6th Edn, 1993. 4. Analytical Chemistry by R.M.Verma CBS Publishers 2nd Edn, 1991. 5. Quantitative chemical analysis by Gilbert H.Ayers. Harper and Row New York 2nd Edn. 1968. 6. A Textbook of pharmaceutical analysis by Kenneth A. Connors. Jon Wiley and sons, 3rd Edn, 1982 7. Analysis chemistry by Gary D. Cheristian, John Wiley and sons N.Y.5th Edn,1994 8. Quantitative analysis by V.Alexeyev. Mir publishers, Moscow, First Edn. 1994. 9. Pharmaceutical Analysis by T.higchi etc. CBS Publishers, New Delhi. First Edn, 1997. 10. Principles of Instrumental Analysis, Skoog, Hollar and Nieman, Harcourt College Publishers, Philadelphia, 1998. © CHARUSAT 2012 Page 94 of 240 PHARMACEUTICAL ENGINEERING-III (PH205) (Theory & Practical) Credits: 3 (Theory) Contact hours per Week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the course: To study unit operations like size reduction, size separation, mixing and crystallization. These Unit operations have applications in manufacturing and compounding of dosage forms. Some unit operations also have applications in manufacturing of bulk drugs. It is also intended to make students familiar with process control systems, industrial hazards and safety precautions. Students learning outcomes/objectives: To develop skills with respect to applications of unit operations like size reduction, size separation, mixing and crystallization, compounding/preparation of pharmaceutical products at laboratory level. To understand construction and working of equipments used for unit operation. To understand applications of these unit operations in manufacturing of drugs/dosage forms. Instructional methods and pedagogy: Black board Over Head Projector or Multimedia projector In addition students shall be demonstrated the working of available equipments in the institute. They can also observe the working of equipments during industrial visit. © CHARUSAT 2012 Page 95 of 240 Outline of the Course (Theory): No. 1 2 3 4 5 6 7 Unit Size reduction Size separation Mixing Crystallization Particle Engineering Automated Process Control Systems Industrial Hazards and Safety Precautions Total Minimum no. of contact hour 08 07 07 09 02 07 05 45 Appprox. Weightage % 17 16 16 20 05 16 10 100% Detail syllabus (Theory): Topic Name Reference Book Size Reduction: • Objectives, theory of size reduction, energy requirement in size reduction, factors influencing size reduction, limit of size reduction, wet and dry milling, application. • Selection of size reduction equipment • Study of various mills including ball mill, hammer mill, fluid energy mill, colloid mill, cutter mill • Introduction to methods of generating nanoparticles Size Separation: • Principles of size separation, screens- types, Pharmacopoeial standards, screening methods • Screening equipments including shaking and vibrating screens, gyratory screens, sedimentation tank, elutriation and cyclone type separators • Application of size separation in pharmacy Mixing: • Theory of mixing, mixing mechanisms, types of mixtures • Solid – solid, solid – liquid and liquid – liquid mixing equipments • Semisolid mixing • Importance of content uniformity in solid dosage forms Crystallization:• Objectives, crystal lattice, types of crystal, crystal form, size and habit, formation of crystals, supersaturation theory, factors affecting crystallization process, crystal growth • Study of various types of crystallizers: Swenson walker, tanks, circulating magma, vacuum and crystal cooling crystallizer • Spherical crystallization and its application in pharmacy • Brief introduction of co-crystals 2,3,4,5 Numbers of Hours 8 2,3,4,6 7 2,3,6 7 1,6,7 9 © CHARUSAT 2012 Page 96 of 240 Particle Engineering: • Introduction • Potential advantages of particle engineered drugs • Particle Engineering Technologies • Challenges with particle engineering approaches Automated Process Control Systems: • Temperature, pressure, vacuum, flow level and their measurements • Elements of automatic process control systems Industrial Hazards and Safety Precautions: • Mechanical, Chemical, Electrical, Fire and dust hazards • Introduction to waste water treatment in industry 7 2 4,8 7 4,9 5 Detail syllabus (Practical): Sr. no. 1. 2. Aim of Practical To study the effect of concentration of solid on the rate of sedimentation by Andersen apparatus. To determine energy utilized by ball mill for size reduction process. 3. To determine particle size distribution of given sample of granules by sieving method. 4. To determine % yield of crystals in crystallization experiment under different conditions. 5. To produce crystals using different conditions of crystallization and to study the crystal habit. 6. To perform the experiment on crystallization and plot mier’s solubility curve. 7. To study the effect of speed and time on solid liquid mixing. 8. 9. To determine the mixing efficiency of two immiscible liquid using variable speed propeller mixer. To determine mixing index of a given powder mixture using double cone blender. 10. To determine the rate of mixing of solid in liquid using a magnetic stirrer at different speeds. 11. Demonstration of following instruments: 12. A. Hammer mill B. Jaw crusher Demonstration of following instruments: A. Vibrating (Oscillating) Sifter B. Double Cone Mixer © CHARUSAT 2012 Page 97 of 240 Recommended study materials: (Latest Edition) 1. Perry’s Chemical Engineer’s Handbook - Robert H Perry, Green D.W., Maloney J.O., McGraw – Hill Inc., New York 2. Tutorial Pharmacy by Cooper & Gunn, ed. S. J. Carter, CBS Publishers & Distributors, Delhi 3. Pharmaceutics The Science of Dosage form Design, Aulton M E, Churchill Livingstone, London 4. The Theory & Practice of Industrial Pharmacy – Lachman L., Lieberman H.A. & Kanjig J.L., Varghese Publishing House, Bombay 5. Alfonso G. Remington: The Science & Practice of Pharmacy. Vol. I & II. Lippincott, Williams & Wilkins Philadelphia 6. Introduction to Chemical Engineering, W. L. Badger and J. T. Banchero, Tata McGraw-Hill Publishing Company Limited, New Delhi 7. Encyclopedia of Pharmaceutical Technology, James Swarbrick, Informa Healthcare, USA 8. Principles and Practice of Automatic Process Control, C. A. Smith and A. Corripio, John Willey & Sons, Inc., USA 9. Industrial Hazards and Plant Safety, Sanjoy Banerjee, Taylor and Francis, New York © CHARUSAT 2012 Page 98 of 240 PHARMACEUTICAL JURISPRUDENCE (PH206) (Theory) Credit: 3 (Theory) Contact hours per Week: 3 (Theory) Objective of the course: To familiarize a student with laws that influences the working of pharmacist in drug store/chemist and druggist/pharmacy or in pharmaceutical industry or in Food and Drug Administration or in an Educational Institute. To familiarize a student with respect to code of ethics given by Pharmacy Council of India. Students learning outcomes/objectives: How to become a responsible person while discharging duty as a pharmacist in different facets of pharmacy profession. To acquire certain knowledge related to laws that help in becoming a pharma entrepreneur. Instructional methods and pedagogy: The lectures will be delivered using Black board Over Head Projector or Multimedia projector By discussing different Cases Outline of the Course (Theory): No 1 2 3 4 5 6 7 8 9 Unit Brief Historical Review of drug legislation in India Code of pharmaceutical ethics given by Pharmacy Council of India Pharmacy Act 1948 Drugs and Cosmetics Act 1940 and Rules 1945 Medicinal and Toilet Preparations (excise duties) Act 1955 Narcotic Drugs and Psychotropic substances Act 1985 and Rules Drugs Price Control Order 1995 Drugs and Magic Remedies (objectionable advertisements) Act, 1954 Medical Termination of Pregnancy Act 1970 and Rules 1975 © CHARUSAT 2012 Minimum no. of contact hours 3 Approx. weightage % 7 2 4 3 11 3 7 25 7 3 7 2 4 2 4 3 7 Page 99 of 240 10 11 12 13 14 15 Prevention of Cruelty to Animals Act 1960 States Shops and Establishments Act and Rules Patent Act1970 and Amendment rules 2005 Poisons Act 1919 Pharmaceutical Policy 2002 A brief introduction of guidelines of regulatory agencies like USFDA and MHRA for approval of manufacturing premises of pharmaceutical industry and comparison of it with Schedule M of Drugs & Cosmetics Act 1940 Total 3 2 3 1 2 7 4 7 2 4 2 4 45 100 Detail syllabus (Theory): No 1 2 3 4 5 6 Unit Brief Historical Review of drug legislation in India: • Advance of Allopathic system • Drug Enquiry Committee and aftermath • Drug act, Pharmacy act and Other Legislation Code of pharmaceutical ethics given by Pharmacy Council of India • General introduction to code of pharmaceutical ethics • Pharmacist in relation to his job, Pharmacist in relation to his trade Pharmacist in relation to medical profession, Pharmacist in relation to his profession • Pharmacist Oath Pharmacy Act 1948: • Introduction, Objectives • Pharmacy Council of India, State Pharmacy Council • Offences and Penalties Drugs and Cosmetics Act 1940 and Rules 1945: • Introduction, Import, Manufacturing, Sale, Labeling and Packaging of Drugs • Administration of Act, Provisions applicable to Ayurvedic, Siddhha and Unani Drugs, Provisions applicable to Homeopathic medicines, Provision applicable to Cosmetics Medicinal and Toilet Preparations (Excise Duties) Act 1955: • Introduction, Manufacturing in Bond, Out side bond • Provisions related to Ayurvedic, Homeopathic, Patent and Proprietary Preparations • Warehousing and Export of alcoholic preparations Narcotic Drugs and Psychotropic substances Act 1985 and Rules: • Introduction • Definitions • Narcotic Drugs • Psychotropic substances © CHARUSAT 2012 Reference Books Minimum no. of contact hours 1,2 3 1,2 2 1,2,7 3 1,2,9,12 11 1,2,10 3 1,2,4 3 Page 100 of 240 7 8 9 10 11 12 13 14 15 • Authorities and Officers • Prohibition, Control and Regulation • Offences and Penalties Drugs Price Control Order 1995: • Introduction • Definitions • Prices of Bulk Drugs • Retail Price of Formulations Drugs and Magic Remedies (objectionable advertisements) Act, 1954: • Introduction, Definitions • Prohibited Advertisements, Prohibition on Import & Export of Advertisements • Offences and Penalties Medical Termination of Pregnancy Act 1970 and Rules 1975: • Introduction • Termination of Pregnancies • Offences and Penalties Prevention of Cruelty to Animals Act 1960 States Shops and Establishments Act and Rules: • Introduction • Registration of Establishment • Work in Establishment, Work Environments, Service Conditions, • Inspection of Establishment • Offences and Penalties Patent Act 1970 and Amendment rules 2005 Poisons Act 1919: • Introduction • Import of Poison • Possession and Sale of Poison • Offences and Penalties Pharmaceutical Policy 2002: • Introduction, Objectives of Pharmaceutical Policy 2002 • Pricing of Pharmaceutical formulations with respect to Pharmaceutical Policy 2002 • Quality Aspects with respect to Pharmaceutical Policy 2002 • Pharma Education and Training with respect to Pharmaceutical Policy 2002 A brief introduction of guidelines of regulatory agencies like USFDA and MHRA for approval of manufacturing premises of pharmaceutical industry and comparison of it with Schedule M of Drugs & Cosmetics Act 1940 Total © CHARUSAT 2012 1,2,6 2 1,2 2 1,2,5 3 1,2,11 3 1,2 2 1,2,3 3 1,2,8 1 1,2,13 2 1,2,14,15 2 45 Page 101 of 240 Recommended study materials: (Latest Edition) 1. A textbook of Forensic Pharmacy by B. M. Mithal 2. A textbook of Forensic Pharmacy by N. K. Jain, Vallbh Prakashan 3. The Patents Act 1970 with Patents Rules 1972 4. The Narcotic Drugs and Psychotropic Substance Act, 1985 (with the Prevention of illicit traffic in Narcotic drugs and Psychotropic Substances Act, 1988 along with Allied Rules and Orders, 1993) 5. The Medical Termination of Pregnancy Act 1971, along with the Medical Termination of Pregnancy Rules 1975 6. The drugs (price control) order 1987-alongwith new drug policy 1994 and drug (price control) order 1995 7. The Pharmacy Act 1948 8. The Poisons Act 1999 9. The Drugs and Cosmetics Act 1940 10. The Medicinal and Toilet Preparations Act 1955 11. Prevention of Cruelty to Animal Act 1960 12. Drugs and Cosmetics Act 1940 by Vijay Malik 13. http://pharmaceuticals.gov.in/acts&policies/pharmaceuticalpolicy2002.pdf/ 14. http://www.fda.gov/ 15. http://www.mhra.gov.uk/ © CHARUSAT 2012 Page 102 of 240 LIFE MANAGEMENT SKILLS (MB220) (Practical) Credits: 1.5 (Practical) Contact Hours per week: 3 (Practical) Objective of the Course: • To prepare students to internalise personality traits so that they can perform their roles in their lives; • To develop the students’ negotiating and salesmanship skills; and • To help the students manage their emotions for achieving a harmonious work-life balance. Student Learning Outcomes / Objectives: At the end of the course, the student should have developed skills and self-confidence necessary for performance in life. Instructional Methods and Pedagogy: • • • Discussions of concepts and cases Exercise-based Practice and Simulation Games Students’ Interview / presentations based on Project Outline of the Course (Theory): No. Unit Minimum No. of Contact Hours 9 Approx. weightage % 1. Understanding & Mapping Personality 2. Forming the Habits for Effectiveness 15 30 3. Emotional Management 15 30 4. Negotiation and Salesmanship 06 20 45 100% Total © CHARUSAT 2012 20 Page 103 of 240 Detailed syllabus (Theory): No. Unit 1. 2. 3. 4. Minimum No. of Contact Hours Understanding & Mapping Personality • Introduction • Personality Factors (Leadership Morale Vs. Individual Motivation) • Types of Personality • Mapping Personality (SWOT Analysis and Exercises) • Building Manners and Etiquettes (Individual / Group) Forming the Habits for Effectiveness • The Seven Habits of Highly Effective People o Being Proactive and Personal Vision Development o Personal Leadership o Time Management o Win-Win and Interpersonal Leadership o Empathic Communication o Synergy and Creative Cooperation o Balanced Self-renewal • The Eighth Habit o Striving for Excellence/ Greatness Emotional Management • Personal o Conflict, Individual Internal Conflict – How to overcome it? o Scope for Introspection o Stress Management & Coping Techniques • Interpersonal o Life Position o Management Development Methods For: o Decision Making: Case Study, In-Basket, Management Games, etc. o Interpersonal Skills: Situation Training, Role-Playing, Transaction Analysis, Johari Window, etc. o Individual’s Knowledge: Conferences, etc. o Group: Crises Management (Disaster) Negotiation and Salesmanship © CHARUSAT 2012 09 15 15 06 Page 104 of 240 Recommended study materials: 1. Stephen R Covey, The 7 Habits of Highly Effective People, Simon & Schuster UK Ltd., 1989 UK. (www.simonsays.co.uk) 2. Covey Stephen R, The 8th Habit from Effectiveness to Greatness, Simon & Schuster UK Ltd. 3. D. M. Pestonjee, Stress and Coping – The Indian Experience, 2nd Edition, Sage Publication, 1992, 99, California. 4. Shiv Khera, You Can Win, Macmillan Co. © CHARUSAT 2012 Page 105 of 240 Bachelor of Pharmacy Programme SYLLABI (Semester – 4) CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY © CHARUSAT 2012 Page 106 of 240 PHARMACOLOGY-I (PH208) (Theory & Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the Course: To make students familiar with the principles of Basic Pharmacology as well as drug action on body systems. Student Learning Outcomes / Objectives: At the end of the course, the student will be able to understand the concept of general pharmacology which is a prerequisite for understanding the concepts of Drug receptor mechanism & molecular action of drug. In addition they will be able to know about drug acting on different organ system. Instructional Methods and Pedagogy: Faculty member/s shall explain in a class room using black board and multimedia projector. Outline of the Course: Sr. No. Unit Minimum No. of Contact Hours Approx. Weightage % 1 General Pharmacology 23 50 2 Drugs acting on ANS & PNS 15 30 3 Drugs Acting on Gastrointestinal System 4 12 4 Drugs Acting on Respiratory System . Total 3 8 45 100% © CHARUSAT 2012 Page 107 of 240 Detailed syllabus (Theory): Sr. No. 1 2 Name of Chapter references General Pharmacology • Definition, scope and branches of Pharmacology. • Routes of drugs administration and drug delivery systems. • Pharmacokinetics of absorption, distribution, biotransformation and elimination of drugs, concept of Half life & Bioavailability • Pharmacodynamics : Mechanisms of drugs action, drug receptors and cellular signaling systems, Dose response relationship • Factors modifying drug dosage and action • Adverse drug effects and monitoring, Iatrogenic diseases. • Drug interactions • New drug development: Basic concept of Preclinical & clinical studies. Drugs acting on Autonomic nervous system • Neurohumoral transmission • Parasympathomimetics and Parasympatholytics • Sympathomimetics ,adrenergic receptor and neurone blocking agents • Ganglion stimulants, blockers ,Neuromuscular blocking agents • Local anaesthetics 1, 2, 5, 6, 7, 8, 10, 11 Hrs. required 23 1 2 10 6 1 1 1 1 1,2,5,6,7,8,9,10, 12 15 1 5 5 2 2 3 Drugs Acting on Gastrointestinal System: • Purgatives • Antidiarrhoeal drugs • Antacids and Antiulcer drugs • Emetics and antiemetics • Prokinetic agents • Digestant, Carminatives, Appetite suppresant 4,5,6,7,8,1,2,10, 12 4 4 Drugs Acting on Respiratory System • Expectorants and Antitussive • ii) Drugs used in Bronchial asthma 1,2,4,3,6,8,7,10, 12 3 © CHARUSAT 2012 Page 108 of 240 Detailed Syllabus (Practical): Sr. No. 1 Topic Introduction to Experimental Pharmacology, some basic Instruments, Laboratory Animals, Standard techniques of drug administration, blood collection, preparation of drug solutions, Euthanasia, Legal aspects related to experiments on animals (CPCSEA). Isolated Tissue Experiments: 2 3 4 5 6 To find out pD2 value of Acetylcholine using rat ileum/ chicken ileum. To study competitive and non competitive antagonism using rat ileum. To identify the nature of given unknown drug using rat ileum / chicken ileum. To study the effect of neostigmine on Concentration Response Curve (CRC) of Acetylcholine using rat ileum/ chicken ileum. To record Concentration Response Curve (CRC) of Acetylcholine using rat ileum/ chicken ileum. Demonstration Experiments 7 8 9 10 11 12 To study the effect of autonomic drugs on rabbit. To study hepatic microsomal enzyme induction & inhibition activity of drugs. To study effect of diuretic drugs using metabolic cage. To evaluate local anesthetics using different animal models To find out plasma protein binding of given drug. To perform practicals related to Absorption, Distribution, Biotransformation & Elimination using simulated model. © CHARUSAT 2012 Page 109 of 240 Recommended study materials: (Latest editions) 1. Goyal R.K.Practicals in pharmacology. M/s B.S.Shah Prakashan, Ahemedabad. 2. Sheth U.K. etal –Selected topics in experimental pharmacology. The Kothari Book Depot, Mumbai. 3. Kulakarni S.K.- handbook of experimental pharmacology. Vallabh Prakashan, New Delhi. 4. Ghosh M.N-Essential of experimental pharmacology scientific book agency, Calcatta. 5. Rang h.P., dale M.M., etal –Pharmacology. Churchill livingstone USA. 6. Satokar R.S et al., Pharmacology and Pharmacotherapeutics. Popular Prakashan, Mumbai. 7. Harval, R.A., Champe P.C. et al., Pharmacolgy Lippincott- Raven Company, Philadephia, New York. 8. Craig C.R., Stitzel, R.E- Modern Pharmacology, Little brown and Company, USA. 9. Goodman and Gilman’s –the pharmacological basis of therapeutics. Pergamon Press, Sigapore. 10. Seth, S.D. text Book of pharmacology, B.I.Churchill 11. Bertram G. Katzung, Basic & Clinical Pharmacology, MC Graw Hill. 12. K.D.Tripathi, Essentials of medical Pharmacology. © CHARUSAT 2012 Page 110 of 240 PHARMACOGNOSY AND PHYTOCHEMISTRY-II (PH209) (Theory & Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the Course: To make students familiar with Pharmacognostic study of glycoside containing crude drugs, utilized as medicine. Student Learning Outcomes / Objectives: The students are expected to • Learn the pharmacognostic aspects specifically, the sources, the preparation methods and utilization of glycoside containing drugs. • Understand basic metabolic pathways of phytoconstituents • Understand concept of phytochemical screening of the phytoconstituents obtained from the natural sources. • Understand basics and applications of Chromatography in Pharmacognosy. Instructional Methods and Pedagogy: The faculty shall explain the lectures • using black board, • using Over Head Projector, Multimedia projector. • through visit of herbal garden Outline of the Course (Theory): No. Unit 1. Study of biological sources, cultivation, collection, commercial varieties, chemical constituents, substitutes, adulterants, uses, diagnostic, macroscopic and microscopic features and specific chemical test of different groups of drugs containing glycosides. General techniques of biosynthetic studies and basic metabolic pathways. Natural allergens and photosensitizing agents. Biological source, preparation, identification tests and uses of different enzymes. Total 2. 3. 4. © CHARUSAT 2012 Minimum No. of Contact Hours Approx. weightage % 23 45 11 30 6 10 5 15 45 100% Page 111 of 240 Detailed syllabus (Theory): No. Unit 1 References Minimum No. of Contact Hours Study of biological sources, cultivation, collection, commercial varieties, chemical constituents, substitutes, adulterants, uses, diagnostic, marcroscopic and microscopic features and specific chemical test of following groups of drugs containing glycosides: Saponins: Liquorice, Ginseng, Dioscorea, Sarsaparilla and Senega. Cardioactive sterols: Digitalis, Squill, Strophanthus, Thevetia. Anthraquinone: Aloe, senna, rhubarb, cascara and Cassia fistula. Coumarins: Psoralea, Ammi visnaga, Ammi majus. 1,2,3,4, 5,6,7,8, 9,10,11,12, 23 14,15,16 Bitter Glycosides: Gentian, Chirata, Quassia. Cyanogenetic: Bitter almond. Isothiocyante: white and black mustard, linseed. Phenolics and Flavonoids 2 General techniques of biosynthetic studies and basic metabolic pathways. An introduction to biogenesis of primary and secondary metabolites 1,2,4, and their interrelationship. 7,13 11 Introduction to acetate-melonate, acetate-mevalonate and shikimic acid pathway. 4 Natural allergens and photosensitizing agents. 1,4,5, 7,15 5 Biological source, preparation, identification tests and uses of following enzymes: Diastase, Papain, Pepsin, Trypsin and Pancreatin. © CHARUSAT 2012 1,2,5, 7,15 Page 112 of 240 6 5 Detailed syllabus (Practicals): No. Aim of the Practical 1 Pharmacognostic study of Liquorice root and histological assessment of the powdered drug. 2 Pharmacognostic study of Dioscorea and histological assessment of the powdered drug. 3 Pharmacognostic study of Senna and histological assessment of the powdered drug. 4 Pharmacognostic study of Digitalis and histological assessment of the powdered drug . 5 Pharmacognostic study of Quassia and histological assessment of the powdered drug. 6 Pharmacognostic study of Chirata stem and histological assessment of the powdered drug. 7 Morphological Evaluation of the Glycoside containing drugs. 8 Chemical Tests for Glycosides. 9 Detection (Assessment of purity) of the given sample of powder mixture comprising of glycoside containing drugs through microscopic evaluation. 10 Detection (Assessment of purity) of the given sample of powder mixture comprising of glycoside containing drugs through microscopic evaluation. 11 Detection (Assessment of purity) of the given sample of powder mixture comprising of glycoside containing drugs through microscopic evaluation. Recommended study materials: 1. Pharmacognosy: C.K.Kokate, A.P.Purohit, S.B.Gokhale, Nirali prakashan, Pune, 39th Edition, 2007. 2. Pharmacognosy and pharmacobiotechnology: Ashutosh Kar, New Age International (P) Ltd, Publishers, 2nd edition 2007. 3. A Text Book of Pharmacognosy: C. S. Shah, J. S. Quadry, B. S. Shah Prakashan, Ahmedabad, 8th edition, 1990. 4. Trease and Evan’s Pharmacognosy: W. C. Evans, W.B.Saunders Co., Singapore, 15th Edition 2008. 5. Pharmacognosy and Phytochemistry, Part I and II, Vinod D. Rangari, Carrier Publications, 1st Edition, Reprint, 2007. 6. Pharmacognosy: V. E. Tylar, L. R. Brady, J. E. Habbers, Lea and Febgir Philadelphia, 8th Edition, 1981. 7. Textbook of Pharmacognosy and Phytochemistry, Biren Shah and A K. Seth, Elsvier Publication, 1st Edition, 2010. © CHARUSAT 2012 Page 113 of 240 8. Anatomy of crude drugs: M. A. Iyenger et al., Manipal Power Press, 11th Edition, 2008. 9. Microscopic profile of powdered drugs used in Indian systems of medicine, Malti G. Chauhan and Pillai A.P.G., volume 1 (2005) and 2 (2007), Gujarat Ayurved University, Jamnagar. 10. Atlas of Microscopy of medicinal plants, culinary herbs and spices, Jackson B. P. and Snowdon D.W., CBS publishers and Distributors (pvt) Ltd., New Delhi, 2005. 11. Indian Herbal Pharmacopoeia, Volume I and II, 1999. A Joint Publication of IDMA and RRL, Jammu –Tawi. 12. Medicinal plant glycosides: Sim. S.K., 2nd Ed. 1966 University of toronto press, Toronto. 13. Medicinal Natural Products. A biosynthetic Approach: Dewick P., 2nd Edition, 2001, John Willey and Sons. 14. Indian Herbal Pharmacopoeia, Published by Indian Drugs Manufacturers Association, Revised new Edition, 2002. 15. Essentials of Pharmacognosy, S. H. Ansari, Birla Publications Pvt. Ltd., 1st edition, 2005-2006 16. Text Book Pharmacognosy: T.E. Wallis, CBS Publishers and Distributors Delhi- 5th Edition, Reprint, 2005. © CHARUSAT 2012 Page 114 of 240 ORGANIC CHEMISTRY-II (PH210) (Theory & Practical) Credit: 3 (Theory) Contact hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the course: • The course is designed to make students familiar with the principles of organic chemistry as applied to pharmaceuticals and to study organic compounds. Students learning outcomes/objectives: • The course will help the student to have a good understanding of the history and basic concepts of organic chemistry. • Students should be able to describe in detail synthetic approaches as well as mechanisms of action of some important organic base therapeutic and diagnostic agents. • The course may help the students in understanding rational approaches towards the design of important therapeutic agents and their biological implications. Instructional methods and pedagogy: • The faculty shall explain the lectures using black board, Over Head Projector or Multimedia projector. Outline of the Course (Theory): No. Unit 1. Benzene and Aromaticity 2. Structure, Nomenclature, physicochemical properties, preparation and reaction of: Arenes, Amines, Phenols, Aldehydes and ketones, Minimum No. of Contact Hours 07 Approx. weightage % 25 55 04 10 09 20 45 100% 15 Carboxylic acid and it’s derivative (amide, ester and anhydride) 3. Electrocyclic cycloaddition and Sigmatrophic reactions, Neighboring group effects catalysis by transition, metal complexes 4. Aspects of Green Chemistry with focus on Microwave synthesis, nano chemistry,New organic reagent used in drug synthesis Total © CHARUSAT 2012 Page 115 of 240 Detailed syllabus (Theory): Sr. No. 1 Unit References Hrs. required 1,2,5,6 07 1,2,5,6 25 1,2,5,6 04 8,9 09 Benzene and Aromaticity Aromatic electrophilic substitution Electrophilic attack on benzene, Nitration, halogenation, sulphonation, Friedal Craft alkylation and acylation, diazocoupling. Orientation in Mono-substituted benzene, Polynuclear Aromatic Compounds – Naphthalene, Anthracene, Phenanthrene Structure, Nomenclature, physicochemical properties, preparation 2 and reaction of: Arenes, Amines, Phenols, Aldehydes and ketones, Carboxylic acid and it’s derivative (amide, ester and anhydride) Electrocyclic 3 cycloaddition and Sigmatrophic reactions, Neighboring group effects catalysis by transition, metal complexes Aspects of Green Chemistry with focus on Microwave synthesis, 4 nano chemistry,New organic reagent used in drug synthesis Detailed syllabus (Practical): Sr. No. 1 2 Aim of the Practical References Identification of Unknown organic compound (acid, base, neutral, phenolic and amphoteric). 1. Synthesis of m-Dinitrobenzene 3, 4,7 2. Synthesis of Aspirin 3, 4,7 3. Synthesis of p-Bromo Acetanilide 3, 4,7 4. Synthesis of p-Nitro Acetanilide 3, 4,7 5. Synthesis of p-Nitro Aniline 3, 4,7 6. Synthesis of Phthalimide 3, 4,7 7. Synthesis of Phenyl Urea 3, 4,7 8. Synthesis of Picric Acid 3, 4,7 © CHARUSAT 2012 Page 116 of 240 3, 4,7 Recommended Study Material: 1. Organic Chemistry by Morrison & Boyd, 6th edition, Pearson Education. 2. Advanced Organic Chemistry: Reaction, Mechanism and Structure by Jerry March 4th edition, A Wiley-Interscience Publication. 3. Vogl’s Text Book of Practical Organic Chemistry- Brian Furniss, Antony Hannaford, Peter Smith, Austrin (Eds), 5th edition, ELBS Publication, Singapore, 1997. 4. Experimental Pharmaceutical Organic Chemistry, A Becnchtop Manual by K. S. Jain, P. B. Miniyar & T. S. Chitre, 2nd Edition Carrier publications,. 5. Organic Chemistry by I. A. Finar 6. A Guidebook to Mechanism in Organic Chemistry by Peter Sykes 7. Organic Chemistry, G. Marc Loudon, 4th Ed., Oxford University Press, 2004. 8. www.sciencedirect.com 9. www.springerlink.com © CHARUSAT 2012 Page 117 of 240 PHARMACEUTICAL ANALYSIS-II (PH211) (Theory & Practical) Credit: 3 (Theory) Contact hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the Course: To make students familiar with the principles of pharmaceutical analysis (Instrumental methods) and its application in pharmacy. Student Learning Outcomes/Objectives: At the end of the course, the student will be able to understand the fundamental concept of pharmaceutical analysis, which is important for qualitative as well as quantitative analysis of drug substances and drug product. Instructional Methods and Pedagogy: Faculty member/s shall explain in a class room using black board and multimedia projector. Outline of the Course (Theory): Sr. No. Unit Minimum No. of Approx. Contact Hours Weightage % 1 Basics of instrumental analytical methods 2 5 2 Chromatography 13 30 Electroanalytical methods: Basics of electroanalytical 20 44 methods 3 Conductometry Potentio and pH metric methods Polarography, amperometry, biamperometry 4 Calorimetry 6 12 5 Polarimetry 4 9 45 100 % Total © CHARUSAT 2012 Page 118 of 240 Detailed Syllabus (Theory): Sr. No. Unit References Basics of instrumental analytical methods: Advantages, 1 limitations, signal to noise ratio. Chromatography: mechanism, 2 Classification, separation theories, efficiency, Hrs. Required 3,4,5 2 3,6,8,9 13 retention methodology and pharmacopoeial applications of column, paper and thin layer chromatography. Electroanalytical methods: Basics of electroanalytical methods 3.1 Conductometry: conductance, Conductance, Kohlrausch law, factors affecting conductivity cells, applications 3.2 Potentio and pH metric methods: Standard reduction potentials, various electrodes, electrodes and cell potential, 3 1,2,3,4, 5,7 applications of potentiometry and pH metry. 20 3.3 Polarography, amperometry, biamperometry: Basics of current flow in polarography, dropping mercury electrode, diffusion current, half wave potential, modifications like pulsed and differential pulse polarography, stripping voltametry, biamperometric titrations, amperometric titrations. Calorimetry: Types, thermogravimetric analysis, differential 4 scanning calorimetry, differential thermal analysis, melting 2,3,4,5 6 2,3,4,5 4 point, etc. and their applications Polarimetry: Polarimeter, qualitative and quantitative 5 applications Note: Above topics should be covered with due consideration of pharmacopoeial applications and numerical. © CHARUSAT 2012 Page 119 of 240 Detailed syllabus (Practical): Sr.No. Aim of Practical References 1 Introduction to instrumental technique 2 4 To determine %w/v of acetic acid with NaOH in given sample solution by pH meter. To determine the % w/v of HCl and acetic acid in mixture with NaOH by conductometer To determine % w/v of NaCl with AgNO3 by conductometer 2,3 5 To determine %w/v of dextrose solution by Polarimeter 1,5 6 To study and demonstration of Paper Chromatography. 2,3 7 To study and demonstration of TLC 8 To study and demonstration of column chromatography 3,5 9 To find out the water content in given sample solution by KFT 2,3 10 To perform the paper chromatography of given sample 2,3 11 To perform the TLC of given sample 12 To determine %w/v of manganese ion in given sample solution with KMnO4 by potentiometer 9 2,3 3 3,4 2,3 2,3 9 Recommended Study Material: 1. Pharmacopoeia: USP, B.P., I.P. 2. Practical Pharm. Chemistry, Vol. B – Backett, The athlone Press of University of London. 3. Quantitative chemical analysis – Vogel A.I, Pearson Education., 5th Edn, 1996. 4. Principles of Instrumental Analysis, Skoog, Hollar and Nieman, Harcourt College Publishers, Philadelphia, 1998. 5. Instrumental method of chemical analysis by Gurdeep Chatwal, Himalaya publishing house, 2005. 6. Quantitative analysis of drugs in pharmaceutical formulations by P.D.Sethi CBS Publishers N.D.3rd Edition, 1997. 7. A Textbook of pharmaceutical analysis by Kenneth A. Connors. Jon Wiley and sons, 3rd Edn, 1982 8. Textbook of Pharmaceutical Analysis – J. W. Munson, Marcel Dekker Inc., New York. 9. Stahl E.; Thin Layer Chromatography, A Laboratory Handbook, 2nd Edn, SpringerVerlag New York, LLC; 1969. © CHARUSAT 2012 Page 120 of 240 PHYSICAL PHARMACEUTICS (PH212) (Theory & Practical) Credit: 3 (Theory) Contact hours per Week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the course: To study basic physical characterization of solid, liquid and gaseous material, which are used during various preparations of formulations. Subject gives the guideline for complex compounds and buffer solution use in pharmaceutical formulations. . Students learning outcomes/objectives: By the end of this course, the student should have a good understanding of the basic concepts of derive properties and measurements powders, rheological properties of liquids and mixing of materials in various field of pharmacy. Students should be able to know the methods of preparation of different buffer solution and Complexation of polymer and drug material. Instructional methods and pedagogy: The lectures will be delivered using Black board or Over Head Projector or Multimedia projector Course Outline (Theory): No. 1 2 3 4 5 6 7 Unit State of matter Micromeritic and Powder Rheology Surface and Interfacial phenomenon : Viscosity and Rheology Dispersion systems Complexation Buffer and isotonic solutions Total © CHARUSAT 2012 Minimum no. of contact hour 6 6 6 6 12 5 4 45 Appprox. Weightage % 13 13 13 13 27 12 9 100% Page 121 of 240 Detailed syllabus (Theory): Sr. Unit details No. 1 States of Matter: State and selected Properties: State of matter. Change in the state of matter, latent heats and vapor pressure, sublimation-critical point, eutectic mixtures, liquid complexes, Liquid crystals, glassy state, solid-crystalline and amorphous, polymorphism, brief introduction of Scanning Electron Microscopy (SEM), Differential Scanning Colorimetry (DSC), X Ray Diffraction (XRD) and Fourier Transform Infra Red Spectroscopy (FTIR) 2 Micromeritic and Powder Rheology : Particle size and distribution, average particle size, number and weight distribution, particle number, methods for determining particle volume, optical microscopy, sieving, sedimentation, measurement of particle shape, specific surface, methods for determining surface area, permeability, adsorption, derived properties of powders (angle of repose, carr’s index and hausner ratio) porosity, packing arrangement, densities, bulkiness and flow properties. 3 Surface and Interfacial phenomenon : liquid interface, surface and interfacial tension, surface free energy, measurement of surface and interfacial tensions, free energy, spreading coefficient, adsorption at liquid interfaces, surface active agents, HLB classification, solubilization, detergency, adsorption at solid interface, solid gas and solid-liquid interface, complex films, electrical properties of interface. 4 Viscosity and Rheology : Newtonian systems, Law of flow, kinematic viscosity, effect of temperature on viscosity, nonNewtonian systems, pseudoplastic, dilatant, plastic, thixotropy, thixotropy in formulation, Determination of viscosity: capillary, falling ball, rotational viscometers, rheopexy, negative thixotropy, viscoelasticity, psychorheology, applications of rheology in pharmacy. 5 Dispersion systems : a. Colloidal dispersions: Definition, types, properties of colloids, protective colloids, applications of colloids in pharmacy. b. Suspensions and Emulsions : Interfacial properties of suspended particles, settling in suspensions, theory of sedimentation, effect of Brownian movement, sedimentation of flocculated particles, sedimentation parameters, wetting of particles, controlled flocculation, flocculation in structured vehicle, rheological considerations, emulsions ; types, theories, physical stability. © CHARUSAT 2012 1,3 Numbers of Hours 6 1,2,3,5 6 1,2,3,4,6,7 6 1,3,6,7 6 1,3,6,7 12 Reference Page 122 of 240 6 Complexation: Classification of complexes, methods of preparation and analysis, applications. 7 Buffer solutions and isotonic solutions: • Buffer solution: buffer capacity, buffer in pharmaceutical systems, preparations and stability of buffer solutions • Isotonic solutions: preparations and stability of isotonic solutions, Measurements of tonicity, calculations and methods of adjusting tonicity. • Buffered Isotonic solutions: Preparations and stability of buffered isotonic solutions 1,2,3,5 5 1,3,4,6,7 4 Detail Syllabus (Practicals): No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. Aim of Practical To determine angle of repose of powder and to study effect of glidents on angle of repose. Determination of particle size using microscopic method of particle size analysis. Determination of derived properties of powders (Density, Porosity, Compressibility) Determination of Critical Micelle Concentration of surfactants and spreading co coefficients. Determination of Surface/Interfacial tension and HLB value of surfactant. Study of rheological properties of various types of systems using different viscometers. Studies of different types of colloids and their properties. Preparation of various types of suspensions and determination of their sedimentation parameters. (A) Preparation of emulsion. (B) To find out type of emulsion and to determine stability of emulsion by Centrifugation Experiment involving tonicity adjustments. (A) To determine effect of temperature on viscosity of given liquid. (B) To determine the viscosity of Newtonian liquid and to calculate relative, absolute and kinematic viscosity. Demonstration of following instruments: • Brook field viscometer • Particle size analyzer © CHARUSAT 2012 Page 123 of 240 Recommended study materials: (Latest Edition) 1. Martin’s Physical pharmacy by Patrick J. Sinko, Lippincott Williams & Wilkins, New York, 2. Pharmaceutics: The Science of Dosage Form Design, Aulton, Michael E., Chrchill Livingstone. 3. Remington: The Science and Practice of Pharmacy, Vol-I & II, Gennaro, Alfonso R., Lippincott Williams & Wilkins, New York. 4. Physicochemical Principles of Pharmacy, Florence, A. T. Atwood, D. Macmillan Press Ltd., London . 5. Pharmaceutical Dosage Forms and Drug Delivery Systems, Ansel, Howard. C., Allen, Loyd V., Popovich, Nicholas G. Lippincott Williams & Wilkins, New York. 6. Cooper and Gunn’s Tutorial Pharmacy, ed. Carter, S. J., CBS Publishers & Distributors, Delhi, . 7. Bentley’s textbook of Pharmaceutics by E. A. Rawlins. © CHARUSAT 2012 Page 124 of 240 HOSPITAL AND COMMUNITY PHARMACY (PH213) (Theory) Credit: 3 (Theory) Contact hours per Week: 3 (Theory) Objective of the course: To study role of pharmacist in hospital and as a community pharmacist. Subject gives the guideline for different department in hospital and their working. Students learning outcomes/objectives: By the end of this course, the student should have a good understanding of the hospital organization and formulary. Students can also know what is the working procedure in hospital as pharmacist in various departments. Students should be able to know the methods of preparation and handing of sterile material in hospital. Students can also be able to work as a community pharmacist as a part of Health Care system. Instructional methods and pedagogy: The lectures will be delivered using Black board Over Head Projector or Multimedia projector Outline of the Course (Theory): Sr. No 1 2 3 4 5 6 7 8 Topic Name Hospital Pharmacy Organization and structure PTC, Hospital Formulary, DIS. Drug store management and inventory control Technical services in Hospital Pharmacy Drug distribution system in hospitals Hospital Biomedical Waste Management Community Pharmacy Central Sterile Supply Unit and their Management TOTAL © CHARUSAT 2012 Minimum no. of contact hour 3 7 6 5 5 4 11 4 45 Appprox. Weightage % 7 15 15 11 11 9 23 9 100 Page 125 of 240 Detailed Syllabus (Theory): Sr. Topic Name No. 1 Hospital Pharmacy Organization and structure: Organization of hospital & hospital pharmacy. Responsibility of hospital pharmacist, Budget preparation and implementation. 2 PTC, Hospital Formulary, DIS: • Pharmacy & therapeutic committee • Hospital formulary: Contents, preparation & revision of hospital formulary • Drug information services: Sources of information on drugs, disease, treatments schedules, procurements of information, computerized services, retrieval of information, Medication error. 3 Drug store management and inventory control: Organization of drug store, types of material stocked, storage conditions; Purchase and inventory control- principles purchase procedures –purchase orders – procurement and stocking. 4 Technical services in Hospital Pharmacy: Manufacture of sterile and non sterile products. Policy making of manufacturable items demand and costing, personnel requirements, manufacturing practice Master formula card, production control, manufacturing records, Asceptic Preparation of IV admixtures, cytotoxic infusions, total parenteral nutrition solution. 5 Drug distribution system in hospitals: out patient dispensing – methods adopted, In patient dispensing – methods adopted, Ambulatory patient dispensing- methods adopted, Dispensing of controlled drugs. 6 Hospital Biomedical Waste Management: Importance, Technology available, treatment and disposal of waste. 7 Community Pharmacy: Organization and structure of retail wholesale drug –store, types of drugs tore and design, legal requirements for establishments, maintenance of drug store, dispensing of proprietary products, maintenance of records of retail and wholesale. (a) Patient counseling. (b) Role and contribution of pharmacist in community health care and education. 8 Central Sterile Supply Unit and their Management: Types of materials for sterilization, Packing of materials prior to sterilization, sterilization equipments, Supply of sterile materials. Reference Numbers of Hours 1,2,7 3 1,2,7 7 1,2,5,7 6 1,2,7 5 1,2,7 5 4 4 3,6 11 1,2,7 4 Recommended study materials: 1. “Hospital Pharmacy “by William E. Hassan, Hanry Kimpton Publishers, London. © CHARUSAT 2012 Page 126 of 240 2. “Hospital Organisation and Management by Kurt Dan & Johnathan S. Ratich , CBS Publishers. 3. Health Education and Community Pharmacy by N.S.Parmar. 4. Hospital Waste Management, Principles and Guidelines by Faisel Khan. 5. Drug Store and Business Management by Ali and Gupta. 6. Modern Patient Counseling by Gaud, Toke, Rathod and Shegde. 7. A textbook on Hospital Pharmacy by Qadry, Goyal and Parikh. 8. Remington: The Science and Practice of Pharmacy, Vol-I & II, Gennaro, Alfonso R., Lippincott Williams & Wilkins, New York. © CHARUSAT 2012 Page 127 of 240 Bachelor of Pharmacy Programme SYLLABI (Semester – 5) CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY © CHARUSAT 2012 Page 128 of 240 PHARMACOLOGY-II (PH301) (Theory & Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the Course: To make students familiar with the principles of pharmacology as well as advance knowledge. Student Learning Outcomes / Objectives: At the end of the course, the student will be able to understand the concept of Pharmacology. Instructional Methods and Pedagogy: Faculty member/s shall explain in a class room using black board and multimedia projector. Outline of the Course (Theory): Sr. No. Unit 1 2 Drugs acting on Central Nervous System Endocrine Pharmacology 3 Autocoids 4 Recent Advances in Molecular Pharmacology & Gene based therapy Heavy metal poisoning. Drugs used in gout and hyperuricemia, rheumatoid arthritis Total 5 6 © CHARUSAT 2012 Minimum No. of Contact Hours Approx. Weightage % 18 40 12 27 6 13 5 11 2 4 2 5 45 100% Page 129 of 240 Detailed syllabus (theory): Sr. Name of Chapter References No. 1 Hrs. required Drugs acting on Central Nervous System: i) Neurohumoral transmission transmission 1,2,3,7,9,4,1 1,12,13 18 7,4,11, 12,13 12 ii) General Anesthetics, Dissociative and neuroleptanalgesia iii) Hypnotics and Sedatives and Centrally acting muscle elaxants iv) Alcohol v) Antiepileptics vi) Psychopharmacological agent vii) Antiparkinsonian drugs viii) Non-steroidal analgesics, anti-inflammatory and anti-pyretic agents x) Opioid analgesics xi) CNS stimulants , Psychotomimetics and Nootropic agents 2 Endocrine Pharmacology: (A) Hypothalamic and Pituitary hormones (B) Thyroid and antithyroid drugs, Parathromone, Calcitonin and Vitamin D (C) Insulin, Oral Hypoglycemic agents and Glucagon (D) Steroids: a)Glucocorticoids b)Mineralocorticoids c)andogen anabolic steroids d)estrogens,progesterons and oral contraceptives (E) Drugs acting on the uterus © CHARUSAT 2012 Page 130 of 240 3 Autocoids: 7,4,5,8 6 8,4,11 5 (A) Histamine,5-HT and their antagonists (B) Prostaglandins, Thromboxanes, Leukotrienes and PAF, Cytokines. (C) Pentagastrin, Cholecystokinin, Angiotensin, Bradykinin and Substance P. (D) brief introduction to cytokines 4 Recent Advances in Molecular Pharmacology & Gene based therapy 5 Heavy metal poisoning. 8,6,7,10 2 6 i) Drugs used in gout and hyperuricemia 11,12,13 2 ii) Drugs used in rheumatoid arthritis and osteoarthritis iii) Osteoarthritis Detailed syllabus (Practical): Sr. No. 1 Aim of practical 2 To study the effect of various tranquilizers & sedatives on motor coordination using Rota-Rod Apparatus. To evaluate anti-Parkinsonian activity of drugs by drug induced catatonia. 3 To evaluate analgesic activity using various methods. 4 To study the effect of psychotropic drugs on condition avoidance response. 5 6 7 8 9. To study the effect of drugs on spontaneous motor activity using Photoactometer. To study the anticonvulsant activity by various model. To evaluate anti-inflammatory activity by various methods. To study anti-anxiety effect using Elevated plus maze apparatus. Introduction to toxicity studies including regulatory toxicology(demonstration of acute toxicity study) To check the sample for presence of pyrogen using various methods. 10. Recommended study materials: 1. Practicals in pharmacology; Goyal R.K. M/s B.S.Shah Prakashan, Ahemedabad. 2. Handbook of experimental pharmacology;Kulakarni S.K. - Vallabh Prakashan, New Delhi. © CHARUSAT 2012 Page 131 of 240 3. Fundamentals of experimental pharmacology;Ghosh M.N- Scientific book agency, Calcutta. 4. Pharmacology; Rang H.P., dale M.M., etal – Churchill livingstone, USA. 5. Pharmacology & Pharmacotherapeutics;Satokar R.S., etal –Popular Prakashan, Mumbai. 6. Pharmacolgy;Harval, R.A., Champe P.C. etal –Lippincott- Raven Company, Philadephia, New York. 7. Derasari and Ghandhi`s Elements of Pharmacology; R,K,Goyal,B.S.Shah Prakashan,Ahmedabad. 8. Goodman and Gilman’s –The pharmacological basis of therapeutics, Pergamon Press, Sigapore. 9. Text Book of pharmacology;Seth, S.D., B.I.Churchill.New Delhi. 10. Basic & Clinical Pharmacology; Bertram G. Katzung, y, MC Graw Hill. 11. Text book of Pharmacology; K.D.Tripathi,. Jaypee Brothers, New Delhi. 12. Principles of pharmacology; H.L. Sharma, K.K. Sharma ., Paras medical publication. 13. Essentials of Pharmacotherapeutics; F.S.K. Barar S.Chand & Co. Ltd., New Delhi. © CHARUSAT 2012 Page 132 of 240 PHARMACOGNOSY AND PHYTOCHEMISTRY-III (PH302) (Theory) Credits: 2 (Theory) Contact Hours per week: 2 (Theory) Objective of the Course: To make students familiar with Pharmacognostic and phytochemical study of Terpenoids, Carotenoids and glycosides. Student Learning Outcomes / Objectives: The students are expected to • Understand the basic idea of extraction, isolation and separation of selected terpenoids, carotenoids and glycosides. • To learn about phytochemical study of terpenoids, carotenoids and glycosides Instructional Methods and Pedagogy: The faculty shall explain the lectures • Using black board, • Using Over Head Projector, Multimedia projector. • through visit of herbal garden Outline of the Course (Theory): No. Unit 1. Chemistry and pharmacological activity of medicinally important Terpenoids. 2. Distribution, chemistry, estimation, pharmacology, commercial and medicinal utilization of Carotenoids. 3. No. of Contact Hours Approx. weightage % 15 40 5 15 10 45 30 100% Distribution, chemistry, isolation, estimation, biogenesis, pharmacology, commercial and medicinal utilization of important glycosides Total © CHARUSAT 2012 Page 133 of 240 Detailed syllabus (theory): Sr. Name of Chapter Reference No. 1. Hrs. Required Introduction to Terpenoids. Their classification and occurance in nature, chemistry and pharmacological activity of medicinally important Monoterpenes- acyclic – geraniol monocyclic- limonene, menthone bicylic- pinene 3,8,9, 10,11,14 15 Sesquiterpenes- borneol 2. Triterpenoids- squalene, stigmasterol, oleanolic acid. Diterpene- abietic acid Distribution, chemistry, isolation, estimation, pharmacology, commercial and medicinal utilization of Carotenoids, with special reference to α- carotene, β- carotene, vitamin A and lycopene. 3. 1,2,4, 6,7,9,11, 5 12,14 Distribution, chemistry, isolation, estimation, biogenesis, pharmacology, commercial and medicinal utilization of 2,5,9,11, important glycosides such as: Digitoxin, Digoxin, Sennoside, 13, 14, 15 10 Aloin, Glycyrrhizin, Diosgenin, Rutin Recommended study materials: 1. Pharmacognosy and pharmacobiotechnology, Ashutosh Kar, New Age International (P) Ltd, Publishers, 2nd edition 2007. 2. Trease and Evan’s Pharmacognosy: W. C. Evans, W.B.Saunders Co., Singapore, 15th Edition 2008. 3. Chemistry of Organic Natural Products, Vol. I and II, O. P. Agrawal, Goel Publishing House, 31st Edition, 2005. 4. Pharmacognosy and Phytochemistry, Part I and II, Vinod D. Rangari, Carrier Publications, 1st Edition, Reprint, 2007. 5. Quality Standards of Indian Medicinal Plants, Volume I and II, A. K. Gupta, ICMR, 2003. 6. Quality Control of Herbal Drugs: Mukherji P. K., Business Horizon Pharma. Publishers, 1st Edition, 2002. © CHARUSAT 2012 Page 134 of 240 7. Herbal drug technology, S. S. Agrawal and M. Paridhavi, Univeristies Press, 1st Edition, 2007. 8. Organic Chemistry of Natural Products Volume I and II: Chatwal G., 7th Reprint 1998, Himalaya Publishing House, Mumbai. 9. Organic Chemistry, Volume- 2, Steriochemistry and the chemistry of Natural Products: Finar I.L., Fifth Edition, 1996, ELBS Publication. 10. Medicinal Natural Products. A biosynthetic Approach: Dewick P., 2nd Edition, 2001, John Willey and Sons. 11. Text Book of Medicinal Chemistry of Natural Products: Pandeya S. A, S G Publishers, 1st Edition, 2007. 12. Indian Herbal Pharmacopoeia, Published by Indian Drugs Manufacturers’ Association, Revised new Edition, 2002. 13. Essentials of Pharmacognosy: S. H. Ansari, Birla Publications Pvt. Ltd., 1st edition, 2005-2006 14. Chemistry of Natural Products, S. V. Bhat et al., Narosa publications,Delhi, reprint 2008. 15. Medicinal Plant Glycosides: Sim. S.K., University of Toronto Press, Toronto, 1986. © CHARUSAT 2012 Page 135 of 240 MEDICINAL CHEMISTRY-I (PH303) (Theory & Practical) Contact Hours per week: 3 (Theory) Credits: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the course: • The course is designed to make students familiar with the principles of medicinal chemistry as applied to pharmaceuticals and to study the synthetic approaches and structure activity relationship of different therapeutic class of drugs. Students learning outcomes/objectives: • By the end of this course, the student should have a good understanding of the history and basic concepts of Medicinal chemistry • Students should be able to describe in detail synthetic approaches, mechanisms of action as well as structure activity relationship of some important therapeutic class of Drugs. • The course may help the students in understanding rational approaches towards the design of important therapeutic agents and their biological implications. Instructional methods and pedagogy: • Using blackboard and one-way communication from a teacher to a student. • Using an overhead and LCD projector Outline of the course (Theory): No. Unit 1 2 3 4 5 Introduction and History of Medicinal Chemistry Chemistry of heterocyclic compounds Drug metabolism Drug receptor interaction The following classes of drugs will be discussed in relation to: Introduction to the rational development of the drug (if any) including Introduction, Chemical classification (if any), Chemical nomenclature, Mechanism of action, Synthesis of the agent mention in the bracket, Structure activity relationship, Therapeutic Uses Total © CHARUSAT 2012 Minimum No. of Contact hours. Approx. Weightage % 02 10 04 03 26 05 25 08 06 56 45 100 % Page 136 of 240 Detailed syllabus (Theory): Unit No. 1 Introduction and History of Medicinal Chemistry 2 Chemistry of heterocyclic compounds: introduction, structures and nomenclature and corresponding drugs of the following Heterocyclic compounds: furan, thiophene, pyrrole, pyrazole, thiazole, imidazole, oxazole, isoxazole, indole, pyridine, pyridazine, pyrimidine, quinoline, isoquinoline, quinazoline, purine Synthesis and Reactions of following compounds: furan, thiophene, pyrrole, indole, imidazole, pyrazole thiazole, pyridine, quinoline and isoquinoline. Drug metabolism: introduction, phase I and II metabolic reactions, biological and environmental factors affecting drug metabolism, pro-drugs & related concepts, importance of cytochrome in drug metabolism Drug receptor interaction: basic introduction for receptor, transduction mechanisms and illustrative examples. 3 4 5 5.1 5.2 The following classes of drugs will be discussed in relation to: Introduction to the rational and recent development of the drug (if any) including • Introduction • Chemical classification (if any) • Chemical nomenclature • Mechanism of action • Synthesis of the agent mention in the bracket • Structure activity relationship • Therapeutic Uses Drugs acting on Autonomic Nervous System • Cholinergics (pyridostigmine) • Anticholinergics and Anticholinesterases • Adrenergics • Sympathomimetic(ephidrin, nor epinephrine, methyl DOPA, nephazoline, isoproterenol, salbutamol,) • Sympatholytics(propranolol) • Neuro muscular junction blocking agents Drugs acting on Respiratory Tract • Antiasthamatic (salbutamol, ephadrin, epinephrine) • Antitussives (codine, chlorpheniramine, diphenylhydramine) • Expectorants (guaifenesin) • Respiratory stimulants © CHARUSAT 2012 Minimum No. of Contact Hours 02 Reference 10 1,2 04 3,4,5 03 3,4,5 26 3,4,5 Page 137 of 240 3,4,5 Drugs acting on Gastrointestinal Tract • Antiemetics (ondensetron) • Antacids (ranitidine) • Antiulcerative agents (pentaprazole) • Antidiarrheals • Laxatives 5.3 • Prokinetic agents • Antispasmodic Agent • Hipetobiliary agent . Detailed Syllabus (Practical): No. Aim of the Practical References 1 Organic spotting of binary mixtures of solid + solid (water insoluble compounds) mixture type along with identification of the type of mixture, chemical separation, identification of the individual components, establishment of the identity of the separated components with the help of derivative preparation and TLC.(Minimum 7) 6,7,8,9,10 2 Preparation of stereo models of some selected drugs. 6,7,8,9,10 3 1. Synthesis of 2-methyl benzimidazole from o-phenylene diamine 6,7,8,9,10 2. Synthesis of benzotriazole from o-phenylenediamine 6,7,8,9,10 3. Synthesis of benzimidazole from o-phenylene diamine 6,7,8,9,10 4. Synthesis of pthalamide from pthalic anhydride 6,7,8,9,10 Recommended Study Material: 1. Organic Chemistry by Morrison & Boyd, 6th edition, Pearson Education. 2. Organic chemistry by I. L. Finar. Vol. I and Vol. II. ELBS/Longman, London 3. Wilson and Giswold's Textbook of Organic, Medicinal and Pharmaceutical Chemistry, Edited by J. N. Delagado and W. A. R. Remers, J. Lipponcott Co. Philadephia. 4. W. C. Foye, Principles of Medicinal Chemistry, Lea & Febiger, Philadelphia. 5. Burger's Medicinal Chemistry, H. E. Wolff, Ed. John Wiley & Sons, New York Oxford University Press, Oxford. 6. Strategies for Organic Drug Synthesis & Design by Daniel Lednicer, John Wiley & sons, USA. 7. Vogel’s Text book of Practical Organic Chemistry, ELBS/ Longman, London 8. Practical Organic Chemistry by Mann & Saunder,, Orient Longman, London. © CHARUSAT 2012 Page 138 of 240 PHARMACEUTICAL BIOCHEMISTRY- I (PH304) (Theory & Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the Course: This course is designed as an introduction to the organic structure of living systems. Lecture will address introduction of Carbohydrate, Proteins, Lipid and enzymes and their metabolism. An understanding of biochemistry is a useful background for many areas of scientific study. It relates the studies of biology and chemistry, allowing an integration of knowledge from both areas of coursework Student Learning Outcomes / Objectives: The students are expected to • Learn the biochemistry aspects specifically, the metabolisms, enzymes, basic chemistry of cell etc. • Understand basic idea of enzymes, biomolecules, and different types of metabolism take place in to the body. • Understand concept of chemistry of living systems which will further help in understanding of drug interaction in the body, drug-protein binding, enzyme inhibition etc. Instructional Methods and Pedagogy: The faculty shall explain the lectures • using black board, • using Over Head Projector, Multimedia projector. Outline of the Course (Theory): No. 1 2 3 4 Unit Introduction to Biochemistry Organization of the cell Biomolecules: definition, classification and it’s function Enzymes Total © CHARUSAT 2012 Minimum No. of Contact Hours 03 04 30 08 45 Approx. weightage % 07 09 66 18 100% Page 139 of 240 Detailed syllabus (Theory): No. Unit Contact References Hours 1 Introduction to Biochemistry: scope of the subject in 03 1,2,3,4,5,6 04 1,2,3,4,5,6 pharmaceutical sciences, Biochemical reactions, highlights of prokaryotic and eukaryotic cell metabolism. 2 Organization of the cell:structure of the cell and cell organelles, transport processes across cell membrane. 3 Biomolecules: Definition, classification and it’s function 3.1 Proteins and classification. its amino metabolism: acids: introduction, classification, 1,2,3,4,5,6 functional 11 1,2,3,4,5,6 10 1,2,3,4,5,6 09 1,2,3,4,5,6 physicochemical properties, optical activity, reaction with ninhydrin, formaldehyde, R-group amino acids. essential, non-essential amino acids, deficiency. Structure: peptide bond, end group analysis.α Helix, β sheet structure. tertiary, quaternary structure, globular protein, fibrous protein, and medicinally important amino acids, biochemical importance, structure of proteins, transamination, deamination, Urea cycle, Degradation of individual amino acids, related inborn errors of metabolism, biosynthesis of catecholamines. 3.2 Carbohydrates and its metabolism: introduction, classification, types of arbohydrates, complex carbohydrates, structure of chitin, starch glycogen glycogenesis, gluconeogenesis, glycolysis, glycogenolysis, pentosephosphate pathway, metabolism of other carbohydrates, regulation of the various pathways of metabolism and related metabolic disorders, citric acid cycle, glyoxalic acid cycle, fermentation. 3.3 Lipids and its metabolism: definition, Classification, Functions, Types of fatty acids and its biological role, lipid biosynthesis and its regulation, triacylglycerol biosynthesis, cholesterol biosynthesis, metabolism and regulation of these processes, ketogenesis and its significance, oxidation of fatty acids. © CHARUSAT 2012 Page 140 of 240 4 08 Enzymes: introduction, classification, (according to the reaction 1,2,3,4,5,6 catalysis and sources) structure of enzymes, co-factor, active sites Km(Michalis- Menten constant), (maximum valosity)Vmax, double reciprocal plot, effect of active substrates, pH ionic strength, conc., temperature on rate of enzymes reactions, enzyme inhibition (competitive, non-competitive, irreversible), concept of antimetabolites, manufacturing of medicinal compounds by enzymatic reactions, Therapeutic uses of enzymes. Detailed syllabus (Practical) No. Aim of Practicals 1 2 3 Reference Analysis of abnormal constituents from urine: sugars, Ketone bodies, bile 7,8,9,10,11 salts, bile pigments and urea-uric acid. Biochemical tests on saliva 7,8,9,10,11 Chemical tests for the identification of carbohydrates, proteins, lipids 7,8,9,10,11 and other biologically important chemical substances Recommended study materials: 1. Principles of Biochemsitry by A. L. Lehninger,, CBS Publishers and Distributors. 2. Harper's Biochemistry, Edited by R. K. Murry, D. K. Granner, P.A. Mayes and V. W. Rodwell, Prentice Hall International Inc., Latest Edition. 3. Biochemistry by S. C. Rastogi, Tata McGraw Hill, New Delhi, Latest Editon. 4. Biochemistry by U. Satyanarayana, Books and Allied (P) Ltd., Calcutta, Latest Edition. 5. Principles of Biochemsitry by G. F. Zubay, W. W. Parson and D. E. Vance, WBC Publishers, England, Latest Edition. 6. Principles of Biochemistry (Paperback), Robert Horton, Laurence A Moran, Gray Scrimgeour, Marc Perry and David Rawn. Pearson Education. 7. An Introduction to Practical Biochemistry by D. T. Plummer,, Tata McGraw Hill, New Delhi. 8. Laboratory Manual in Biochemistry, Willey, Eastern Limited, New Delhi. 9. Practical Biochemistry: Principles and Techniques, 5th ed. Cambridge : Cambridge University Press, 2003 10. Introductory Practical Biochemistry, Singh R. and Sawhney, S.K., New Delhi : Narosa Publishing House, 2002 11. P. G. Tikekar, Practical Biochemistry for medical students, Ed. 4 Publ. Mrs. Nalini. P. Tikekar, Bombay,1964. © CHARUSAT 2012 Page 141 of 240 PHARMACEUTICAL MICROBIOLOGY (PH305) (Theory & Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the course: • To study the microbial growth including microscopy and staining techniques for identification of microorganisms. • To study the various microbial growth controlling techniques and various other tests used for detection of microorganisms. Students learning outcomes/objectives: • The course will help the student to have a good understanding about the growth cycle of microorganisms including effects of various chemical agents on their growth and various staining techniques used for identification of microorganisms by using microscope. • Students will be able to describe the various methods used for controlling the growth of microorganisms in various fields of pharmaceutical industries. • Students will be able to describe various tests for detection of presence of microorganisms in sterile and non-sterile dosage forms. Instructional methods and pedagogy: • The faculty shall explain the lectures using black board, Over Head Projector or Multimedia projector. Outline of the Course (Theory): No. 1. Unit Introduction to the Pharmaceutical microbiology Minimum No. of Approx. Contact Hours Approx. Weight age % 5 2 2. Microscopy 1 2 3. Structure of bacterial cell 1 2 4. Classification of microbes 5 11 5. Identification of microbes 3 6 6. Microbial Growth 7 16 7. Control of Microbes in Pharmaceutical Industry 14 31 © CHARUSAT 2012 Page 142 of 240 8. Sterility testing 4 9 9. Microbiological assay 4 9 10. Microbial Limit Tests 4 9 45 100 Total Detailed syllabus (theory): Sr. no 1 2 3 4 5 6 7 8 9 10 Unit Details Introduction to the Pharmaceutical microbiology: Introduction, scope, contributions of great scientists to microbiology Microscopy Structure of bacterial cell Brief introduction of microbes: Taxonomy, bacteria, ricketssiae, spirochetes and viruses. Identification of microbes: Stains & types of staining techniques Microbial Growth: Nutrition, cultivation, isolation and count of bacteria, fungi, viruses etc Control of Microbes in Pharmaceutical Industry: A. Classification and mechanism/s of action of disinfectants, Disinfection, factors influencing disinfectants, dynamics of disinfection, disinfectants & antiseptics and their evaluation ( Bacteriostatic & Bacteriocidal test) B. Sterilization: Definition, Sterilizers, different methods of sterilization, validation of sterilization methods & equipments Sterility testing of pharmaceutical product: Principle, Media for sterility testing, Methods of sterility testing, interpretation of results. Microbiological assay of Antibiotics, Vitamins and amino acids Microbial Limit Tests for Pharmaceutical Dosage Forms as per IP © CHARUSAT 2012 Reference Book Numbers of Hours 1,2,3 2 2,6,8 2,6,8 1 1 2,6,7 5 1,4,6,9 3 2,6,7,9 7 2,5,10,11,13 14 2,11,12 4 2,11,12 4 12 4 Page 143 of 240 Detailed syllabus (Practical): Sr. No. Aim of Practical Study of different types of equipments used in microbiology laboratory. 1. A B Observation of microbes by simple staining or monochrome staining. To Carry out Grams staining of given culture. 2. A B 3. A B Cultivation of micro-organisms in N-broth Media and N-Agar Slant. To Observe the motility of bacteria by hanging drop technique. To Observe Oligodynamic effect of metal on growth of micro-organisms. Cultivation of anaerobes by stab method. 4. A B To Observe the morphology of micro-organisms by negative staining. Study of effect of UV light on growth of micro-organisms. 5. Evaluation of Disinfectant by (a) agar cup method (b) Filter paper disc 6. method. To Perform sterility testing of absorbent cotton gauze. 7. A B To Perform sterility testing of ampoules and vials having water for injection. C To Perform sterility testing of soluble powders. Estimation of potency of given antibiotic (streptomycin) by microbial assay 8. (One & Two level fractional assay). Determination of phenol coefficient of given disinfectant by Riedal Walker 9. test. To Perform the spirochetes staining by negative staining method and 10. A Fontana’s method. B 11. A To Determine the viable count of micro-organisms by using Petri plate method. To Perform the spore staining by Dorner’s method. B Cultivation and Isolation of micro-organisms by streak plate method. 12 To Perform sterility testing of vaccines © CHARUSAT 2012 Page 144 of 240 Recommended study materials: 1) Pharmaceutical Microbiology, Edited by W.B. Hugo and A.D. Rusell Blackwell Science, United Kingdom. 2) Microbiology An Inroduction, G. J. Tortora, B. R. Funke, Pearson Education, New Delhi. 3) Textbook of Microbiology, C. K. J. Paniker, Orient Longman PVT LTD., India. 4) Microbiology, Prescott L. M., McGraw Hill, Columbus. 5) Industrial Microbiology, L. E. Casida, JR., New Age International Publishers, India. 6) Microbiology, M. J. Pelczar, JR., E.C.S. Chan and N. R. Krieg, Tata Mc Graw-Hill, Inc., New York. 7) Fundamental Principles of Bacteriology. A.J. Sale, Tata Mc Graw-Hill Publishers Company Ltd., New York. 8) General Microbiology, Stanier R. Y., Machillan Press Ltd., Hampshire. 9) Microbiology A Laboratory Manual, J. G. Cappuccino, Pearson Education, New Delhi. 10) Remington: The Science and Practice of Pharmacy, Vol I & II, Gennaro Alfonso R., Lippincott Williams & Wilkins, New York. 11) Pharmaceutical Microbiology, Ashutosh Kar, New Age International publishers, New Delhi. 12) Indian Pharmacopoeia 2007, Indian Pharmacopoeial Commission, Ghaziabad. 13) Bentley’s Text Book of Pharmaceutics, Edited by E. A. Rawlins, Bailliere Tindall, United Kingdom. Note: It is preferable to refer latest addition of all above mentioned books © CHARUSAT 2012 Page 145 of 240 PHARMACEUTICAL BIOTECHNOLOGY (PH306) (Theory) Credits: 2 (Theory) Contact Hours per week: 2 (Theory) Objective of the course: • To study microbial genetics and application of recombinant DNA Technology in drug design Students learning outcomes/objectives: • The course will help the student to have a good understanding about the microbial genetics and microbial biotransformation processes. Instructional methods and pedagogy: • The faculty shall explain the lectures using black board, Over Head Projector or Multimedia projector. Outline of the Course (Theory): No. Unit 1 Microbial genetics and variation 2 Genetic recombination 3 4 Recombinant DNA Technology, gene cloning and their application Microbial Transformation 5 Enzymes 6 Safety in Biotechnology Total © CHARUSAT 2012 Minimum No. of Contact Approx. Hours Approx. Weightage % 4 13 6 20 5 17 8 27 4 13 3 30 10 100 Page 146 of 240 Detailed Syllabus (Theory): Sr. Unit Details No 1. Microbial genetics and variation 2. Genetic recombination: Transformation, Conjugation, protoplast fusion and their application. 3. Recombinant DNA Technology, gene cloning and their application 4. Reference Numbers Book of Hours 1,3,7,9,10 4 1,9,10,11 6 1,4,9,10,11 5 1,7,8,9 8 7,8,9,10 4 2,5,6,11,12 3 Microbial Biotransformation: Introduction, types of reaction mediated by microorganisms, design of biotransformation processes, types of selection of organisms, biotransformation process and its improvements with special reference to steroids. 5. Enzymes: Techniques of immobilization of enzymes, factors affecting enzyme kinetics. Study of enzymes such as hyaluronidase, penicillinase, streptokinase and streptodornase, amylase & proteases etc. 6. Safety in Biotechnology: Introduction, Biosafety, Pathogenic Microorganisms and Fungi Recommended Study Materials: 1) Microbiology, M. J. Pelczar, JR., E.C.S. Chan and N. R. Krieg, Tata Mc Graw-Hill, Inc., New York. 2) Industrial Microbiology, L. E. Casida, JR., New Age International Publishers, India. 3) Fundamental Principles of Bacteriology, A. J. Sale, Tata McGrew Hill Publishers Company Ltd., New York 4) Bentley’s Text Book of Pharmaceutics, Edited by E. A. Rawlins, Bailliere Tindall, United Kingdom. 5) Remington: The Science and Practice of Pharmacy, Vol I & II, Gennaro Alfonso R., Lippincott Williams & Wilkins, New York. 6) Microbiology A Laboratory Manual, J. G. Cappuccino, Pearson Education, New Delhi. 7) Pharmaceitical Biotechnology, Asutosh Kar, New Age International publishers, New Delhi. 8) Pharmaceutical Biotechnology, S.S. Purohit, H. N. Kakrani, Student Edition, Jodhpur. © CHARUSAT 2012 Page 147 of 240 9) Pharmaceutical Biotechnology Concept & Applications, Gary Walsh, John Willey & Sons Inc., New York. 10) Pharmaceutical Biotechnology, S. P. Vyas & V. K. Dixit, CBS Publishers & Distributors, New Delhi. 11) Pharmaceutical Biotechnology, Edited by M. J. Groves, Taylor & Francis, New York. 12) Biotechnology & Biopharmaceuticals, Roney B. Y. HO, Milo Gibaldi, John Willey & Sons Inc., New York. Note: It is preferable to refer latest addition of all above mentioned books © CHARUSAT 2012 Page 148 of 240 BIOSTATISTICS (MA331) (Theory & Practical) Credits: 2 (Theory) Contact Hours per week: 2 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the Course: To prepare students to understand the basic statistics in Pharmacy discipline. Student Learning Outcomes / Objectives: To prepare student to interpret statistical summaries of data and results of statistical techniques Instructional Methods and Pedagogy: The faculty shall explain the lectures • Using black board, • Using Over Head Projector, Multimedia projector. • Using the computer softwares Outline of the Course (Theory): No. Unit Minimum No. of Contact Hours 1 Introduction to Biostatistics 1 2 Types of data in biostatistics 5 3 Descriptive Statistics Introduction to Probability and Probability 4 Distributions 4 5 Basic Statistical Inference 7 6 Regression and Correlation Total 4 26 © CHARUSAT 2012 Approx. weightage % 5 20 15 20 5 25 15 100 % Page 149 of 240 Detailed Syllabus (Theory): No. 1 Contact Unit details Hours Introduction to Biostatistics 1 History and development 2 Types of data in biostatistics, Samples and population, 5 Variables in biostatistics, accuracy and precision of data Frequency distribution, tables and graphs 3 Descriptive Statistics 4 The Arithmetic Mean, Other Means The Median, The Mode The Range, The Standard deviation and coefficient of variation 4 Introduction to Probability and Probability Distributions 5 Basic Probability Probability Distribution: Binomial, Poisson distribution Normal Distribution 5 Basic Statistical Inference 7 Sample Statistic and Parameter Estimation of Population Mean and Population Variance Distribution and variance of sample statistics Student's t distribution and Chi - square distribution Introduction to Confidence limits 6 Regression and Correlation 4 Introduction to Regression: Concept of dependent and independent variables Simple linear regression The Product Moment correlation coefficient © CHARUSAT 2012 Page 150 of 240 Detailed Syllabus (Practical): Sr No Topic 1 Introduction to Microsoft Excel 2 Entering statistical data in excel and graphical presentation 3 Computing Arithmetic Mean, Median, Mode 4 Computing Quartiles, Percentiles 5 Computing Measures of dispersions 6 Computing probabilities using excel functions and formula for Binomial distribution 7 Computing probabilities using excel functions and formula for Poisson distribution 8 Computing probabilities using excel functions and formula for Normal distribution 9 Generating Random numbers from Discrete distribution 10 Generating Random numbers from Continuous distribution 11 Sampling distributions (t ,F and Chi Square distribution) Computing confidence limits using excel functions 12 Bivariate data analysis: Computing Karl Pearson correlation coefficient, and Linear regression using excel functions Recommended study materials: Reference Books 1. Pharmaceutical Statistics: Practical and Clinical Applications by Stanford Bolton, Charles Bon. (Fourth Edition) Marcel Dekker 2. Fundamentals of Biostatistics by Bernard Rosner (5th Edition) Duxbury – Thompson Learning 3. Introduction to Biostatistics by Robert R. Sokal and F. James Rohlf (Second Edition) Dover Publications © CHARUSAT 2012 Page 151 of 240 Bachelor of Pharmacy Programme SYLLABI (Semester – 6) CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY © CHARUSAT 2012 Page 152 of 240 PHARMACOLOGY-III (PH308) (Theory & Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the Course: To make students familiar with the principles of pharmacology as well as advance knowledge. Student Learning Outcomes / Objectives: At the end of the course, the student will be able to understand the concept of Pharmacology. Instructional Methods and Pedagogy: Faculty member/s shall explain in a class room using black board and multimedia projector. Course Outline: Sr. No. 1 2 3 4 5 Unit Pharmacology of Cardiovascular System Drugs Acting on the Hemopoietic System Drug acting on Kidney Chemotherapy Immunomodulators Total © CHARUSAT 2012 Minimum No. of Contact Hours Approx. Weightage % 14 31 7 16 2 4 20 45 02 4 45 100% Page 153 of 240 Detailed syllabus (Theory): Sr. No. 1 2 3 4 5 Topic References Pharmacology of Cardiovascular System a) Cardiac glycosides and other Cardiotonics b)Antihypertensive drugs c)Anti-anginal drugs d)Anti- arrhythmic drugs e) Anti-hyperlipidemic drugs f) Drugs used in the therapy of shock Drugs Acting on the Hemopoietic System. a)Hematinics b)Anticogaulants, Vitamin K and Hemostatic Drugs c)Fibrinolytic and Anti- platelet drugs d)Blood and Plasma Volume Expanders Drug acting on Kidney a)Diuretics Chemotherapy : a) General Principles of Chemotheraphy b) Sulphonamides and Co- trimoxazole c) Antibiotics: Penicillins, Cephalosporins, Beta- lactams, Macrolides, Tetracyclines Chlormphenicol, aminoglycosides, quinolones and miscellaneous antibiotics including newer antibiotics d) Chemotherapy of Tuberculosis and Leprosy e) Antifungal agents f) Antiviral agents g) Chemotherapy of Sexually Transmitted Diseases and AIDS h) Drugs used in the Therapy of Protozoal Infections: Antimalarial and antiamoebic drugs i) Anthelmintic drugs k) Anti-malignant agents j) Immunomodulators: Immunostimulants and Immnosupperssants 1,2,3,4,8,7,13 Hrs required 14 1,2,3,5,6,12 7 1,2,3,11 2 4,8,7,9,10 20 4,8 02 © CHARUSAT 2012 Page 154 of 240 Detailed syllabus (Practical): Sr. Aim of Practical No. 1 To study Bioassay of agonists using rat ileum / Chicken ileum by following methods: a) Graphical method b) Matching method c) Three and four point ( multiple point) method 2 To study Bioassay of antagonists using rat ileum / Chicken ileum by following methods: a) Graphical method b) Matching method c) Three and four point ( multiple point) method 3 To study the diuretic effect of the drug using suitable animal model. 4 To study the effect of drugs on the coronary blood flow and heart rate using isolated rats heart (Langendorff’s preparation). 5 To study the effect of various drugs on the rat anococcygeus muscle. 6 To study the effect of 5-HT on rat fundus strip preparation. 7 To study the effect of various drugs on the blood pressure of anaesthetized rat. 8 To study the effect of various drugs on rat uterus. 9 To study the effect of various drugs on rat vasdeferens. Recommended study materials: 1. Practicals in pharmacology; Goyal R.K. M/s B.S.Shah Prakashan, Ahemedabad. 2. Handbook of experimental pharmacology;Kulakarni S.K. - Vallabh Prakashan, New Delhi. 3. Fundamentals of experimental pharmacology;Ghosh M.N- Scientific book agency, Calcutta. 4. Pharmacology; Rang H.P., dale M.M., etal – Churchill livingstone, USA. 5. Pharmacology & Pharmacotherapeutics;Satokar R.S., etal –Popular Prakashan, Mumbai. © CHARUSAT 2012 Page 155 of 240 6. Pharmacolgy;Harval, R.A., Champe P.C. etal –Lippincott- Raven Company, Philadephia, New York. 7. Derasari and Ghandhi`s Elements of Pharmacology; R,K,Goyal,B.S.Shah Prakashan,Ahmedabad. 8. Goodman and Gilman’s –The pharmacological basis of therapeutics, Pergamon Press, Sigapore. 9. Text Book of pharmacology;Seth, S.D., B.I.Churchill.New Delhi. 10. Basic & Clinical Pharmacology; Bertram G. Katzung, y, MC Graw Hill. 11. Text book of Pharmacology; K.D.Tripathi,. Jaypee Brothers, New Delhi. 12. Principles of pharmacology; H.L. Sharma, K.K. Sharma ., Paras medical publication. 13. Essentials of Pharmacotherapeutics; F.S.K. Barar S.Chand & Co. Ltd., New Delhi. © CHARUSAT 2012 Page 156 of 240 PHARMACOGNOSY AND PHYTOCHEMISTRY-IV (PH309) (Theory & Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the Course: To make students familiar with Pharmacognostic and phytochemical studies of alkaloids containing plants. Student Learning Outcomes / Objectives: The students are expected to • Learn the pharmacognostic aspects specifically, the sources, the preparation methods and utilization of alkaloids containing crude drugs • Understand the Phytochemistry of alkaloids • Learn about the plants used as Natural colorants, fragrance and sweetening agents Instructional Methods and Pedagogy: The faculty shall explain the lectures • using black board, • using Over Head Projector, Multimedia projector. • through visit of herbal garden Outline of the Course (Theory): No. Unit 1. Minimum No. of hours Approx. weightage % 20 45 21 35 4 20 45 100% Systematic study of source, cultivation, collection, processing, commercial varieties, chemical constituent’s substitutes, uses, diagnostic macroscopic and microscopic features and specific chemical tests of alkaloids containing drugs. 2. Distribution, chemistry, isolation, estimation, biogenesis, pharmacology, commercial and medicinal utilization of some important alkaloids. 3. Natural colorants, fragrance and sweetening agents Total © CHARUSAT 2012 Page 157 of 240 Detailed syllabus (theory): Sr. Name of Chapter Reference Required No 1 Hrs. Systematic study of source, cultivation, collection, processing, commercial varieties, chemical constituent’s substitutes, uses, diagnostic macroscopic and microscopic features and specific chemical tests of following alkaloids containing drugs : Pyridine-piperidine-Tobacco, Areca and Lobelia. Tropane: Belladona, Hyoscyamus, Datura, Duboisia, Coca and Withania. Quinoline and isoquinoline: Cinchona, Ipecac, Opium, Camptotheca. Indole: Ergot, Rauwolfia, Catharanthus, Nux- vomica and Physostigma. Imidazole: Pilocarpus. 1,2,3, 4,6,7,8, 20 10,15,16 Steroidal: Kurchi and Veratrum. Alkaloidal amine: Ephedra, Colchicum. Glycoalkaloid: Solanum. Purines: Coffee, Tea and Cola. Quinozoline: Vasaka 2 3 Distribution, chemistry, isolation, estimation, biogenesis, pharmacology, 5,8, commercial and medicinal utilization of some important alkaloids such 10,12,13, as: Atropine, Quinine, Ephedrine, Caffeine, Reserpine, Ergotamine, 14,15,16, Morphine, Vincristine and Vinblastine. 17,18 Natural colorants, fragrance and sweetening agents 19,20 © CHARUSAT 2012 Page 158 of 240 21 4 Detailed syllabus (Practical): No. Aim of the Practical 1 Pharmacognostic study of Datura and histological assessment of the powdered drug 2 Pharmacognostic study of Vasaka and histological assessment of the powdered drug 3 a) Pharmacognostic study of Rauwolfia and histological assessment of the powdered drug b) Pharmacognostic study of Ipecac and histological assessment of the powdered drug 4 Pharmacognostic study of Kurchi and histological assessment of the powdered drug 5 a) Pharmacognostic study of Nux-Vomica and histological assessment of the powdered drug b) Pharmacognostic study of Cinchona and histological assessment of the powdered drug 6 Pharmacognostic study of Ephedra and histological assessment of the powdered drug 7 Pharmacognostic study of Withania root/leaf and histological assessment of the powdered drug 8 Isolation of Nicotine from tobacco powder and its TLC identification. 9 Isolation of Caffiene from tea powder and its TLC identification. 10 Isolation of Piperine from pepper powder and its TLC identification. 11 Isolation of Solasodine from solanum powder and its TLC identification. 12 Isolation of Berberine and its TLC identification. Recommended study materials: 1. Pharmacognosy: C.K.Kokate, A.P.Purohit, S.B.Gokhale, Nirali prakashan, Pune, 39th Edition, 2007. 2. Pharmacognosy and pharmacobiotechnology, Ashutosh Kar, New Age International (P) Ltd, Publishers, 2nd edition 2007. 3. A Text Book of Pharmacognosy: C. S. Shah, J. S. Quadry, B. S. Shah Prakashan, Ahemedabad, 8th edition, 1990 4. Trease and Evan’s Pharmacognosy: W. C. Evans, W.B.Saunders Co., Singapore, 15th Edition 2008. 5. Chemistry of Organic Natural Products, Vol. I and II, O. P. Agrawal, Goel Publishing House, 31st Edition, 2005. 6. Pharmacognosy and Phytochemistry, Part I and II, Vinod D. Rangari, Carrier Publications, 1st Edition, Reprint, 2007. 7. Pharmacognosy: V. E. Tylar, L. R. Brady, J. E. Habbers, Lea and Febgir Philadelphia, 8th Edition, 1981. 8. Quality Standards of Indian Medicinal Plants, Volume I to VII, A. K. Gupta, ICMR, 2003. © CHARUSAT 2012 Page 159 of 240 9. Quality Control of Herbal Drugs: Mukherji P. K., Business Horizon Pharma. Publishers, 1st Edition, 2002. 10. Herbal drug technology, S. S. Agrawal and M. Paridhavi, Univeristies Press, 1st Edition, 2007. 11. Organic Chemistry of Natural Products Volume I and II: Chatwal G., 7th Reprint 1998, Himalaya Publishing House, Mumbai. 12. Organic Chemistry, Volume- 2, Steriochemistry and the chemistry of Natural Products: Finar I.L., Fifth Edition, 1996, ELBS Publication. 13. Medicinal Natural Products. A biosynthetic Approach: Dewick P, 2nd Edition, 2001, John Willey and Sons. 14. A Text Book of Medicinal Chemistry of Natural Products: Pandeya S., S G Publishers, 1st Edition, 2007. 15. Indian Herbal Pharmacopoeia, Published by Indian Drugs Manufacturers’ Association, Revised new Edition, 2002. 16. Medicinal Plant Alkaloids: Sim. S.K., University of Toronto Press, Toronto, 1986. 17. Phytochemical methods: Harborne J.B., 3rd Edition, 1998 Chapman and Hall London. 18. Chemistry of Natural Products, S. V. Bhat et al., Narosa publications, Delhi, reprints 2008. 19. Wells F.V. and Billot M. Perfumery Technology, Art: Science: Industry. 1st Edition, 1981. Ellis Horwood Ltd, London. 20. Bhatia S.C. Perfumes, Soaps, Detergents and Cosmetics. Volume II. 1st Edition, 2001. CBS Publishers and Distributors. New Delhi. © CHARUSAT 2012 Page 160 of 240 MEDICINAL CHEMISTRY-II (PH310) (Theory & Practical) Credits: 2 (Theory) Contact Hours per week: 2 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the course: • The course is designed to make students familiar with the principles of medicinal chemistry as applied to pharmaceuticals and to study the synthetic approaches and structure activity relationship of different therapeutic class of drugs. Students learning outcomes/objectives: • By the end of this course, the student should have a good understanding of the basic concepts of Medicinal chemistry • Students should be able to describe in detail synthetic approaches, mechanisms of action as well as structure activity relationship of some important therapeutic class of Drugs. • The course may help the students in understanding rational approaches towards the design of important therapeutic agents and their biological implications. Instructional methods and pedagogy: • Using blackboard and one-way communication from a teacher to a student. • Using an overhead and LCD projector Outline of the course (Theory): No. Unit 1 The following classes of drugs will be discussed in relation to: Introduction to the rational and recent development of the drug (if any) including • Introduction • Chemical classification (if any) • Chemical nomenclature • Mechanism of action • Synthesis of the agent mention in the bracket • Structure activity relationship • Therapeutic Uses Total © CHARUSAT 2012 Minimum No. of Approx. Contact hours. Weightage % 30 100 30 100 % Page 161 of 240 Detailed syllabus (Theory): No. 1 1.1 1.2 1.3 Unit No. of Hours Reference The following classes of drugs will be discussed in relation to: Introduction to the rational and recent development of the drug (if any) including • Introduction • Chemical classification (if any) • Chemical nomenclature • Mechanism of action • Synthesis of the agent mention in the bracket • Structure activity relationship 1,2,3 • Therapeutic Uses Drugs acting on Central Nervous System • General and local anesthetics (ketamine, helothen, thiopenton, lignocaine, lidocaine, procaine) • Hypnotics and sedatives (phenobarbitone, amilobarbitone, methohexital) • Opioid analgesics (pthadine hydrochloride, dextrepropoxyphene) • Anti convulsants (diphenylhydentoin, ethosuximede, trimethadione) • Anti Parkinsonism drugs (L-DOPA) • CNS stimulants (nikethamide, bemegride) • Neuroleptics (nitrazepam, diazepam, chlorpromazine, haloperidol, tybamate, meprobemate) • Antidepressants (amitriptyline, emiprimine,doxepin) • Anxiolytics (nitrazepam,diazepam) Hormones : discussion of chemistry and drug action • Thyroid hormone and anti-thyroid agents • Insulin and hypoglycemic agents • Steroid hormones – adrenal cortex hormones and sex hormones (progesterone, dienestrol, diethylstilbestrol) Chemistry of Autocoids • Eicosanoids and their synthesis inhibitors 15 1,2,3 05 1,2,3 02 1,2,3 1.4 NSAIDs (paracetamol, ibuprofen, indomethacin, meclifenamate sodium) 02 1,2,3 1.5 Antiallergic agents (chlorpheniramine, pheniramine antazoline) 02 1,2,3 1.6 Pharmaceutical Aids 02 1,2,3 1.7 Diagnostic Agents 02 1,2,3 © CHARUSAT 2012 Page 162 of 240 Detailed Syllabus (Practical): Topic No. Aim of the Practical Referen ces 1 Organic spotting of binary mixtures of solid + solid (all type) along with identification of the type of mixture, chemical separation, identification of the individual components, establishment of the identity of the separated components with the help of derivative preparation and TLC.(Minimum 7) 4,5,6,7 2 Preparation of stereo models of some selected drugs (examples of drugs). 4,5,6,7 3 1. Synthesis of aspirin from salicylic acid 4,5,6,7 2. Synthesis of N-acetyl glycine from glycine 4,5,6,7 3. Synthesis of benzillic acid from benzyl 4,5,6,7 4. Synthesis of benzil from benzoin 4,5,6,7 5. Synthesis of benzaldehyde phenyl hydroxime from benzaldehyde 4,5,6,7 Recommended Study Material: 1. Wilson and Giswold's Textbook of Organic, Medicinal and Pharmaceutical Chemistry,J. N. Delagado and W. A. R. Remers, Eds, J. Lipponcott Co. Philadephia. 2. Principles of Medicinal Chemistry by W. C. Foye,, Lea & Febiger, Philadelphia. 3. Burger's Medicinal Chemistry, H. E. Wolff, Ed. John Wiley & Sons, New York Oxford University Press, Oxford. 4. Strategies for Organic Drug Synthesis & Design by Daniel Lednicer, John Wiley & sons, USA. 5. Organic Chemistry by L. Finar, Vol. I & II, ELBS/ Longman, London. 6. Vogel’s Text book of Practical Organic Chemistry, ELBS/ Longman, London. 7. Practical Organic Chemistry by Mann & Saunder,, Orient Longman, London. © CHARUSAT 2012 Page 163 of 240 PHARMACEUTICAL BIOCHEMISTRY-II (PH311) (Theory & Practical) Credits: 2 (Theory) Contact Hours per week: 2 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the Course: This course is designed as an introduction to the organic structure of living systems. Lecture will address introduction of Vitamins, clinical biochemistry, Genetic code and protein synthesis and Nucleic Acids. An understanding of biochemistry is a useful background for many areas of scientific study. It relates the studies of biology and chemistry, allowing an integration of knowledge from both areas of coursework Student Learning Outcomes / Objectives: The students are expected to • Learn the biochemistry aspects specifically, the metabolism, nitrogen and sulphur cycles, gene code in protein formation, chemistry basic information regarding DNA and its replication, RNA types and its transcription and translation ect. • Understand basic idea of enzymes, protein, vitamins and biological oxidation process in living cells. • Understand concept of chemistry of living systems which will further help in understanding of drug interaction in the body, drug-protein binding ect. Instructional Methods and Pedagogy: The faculty shall explain the lectures • using black board, • using Over Head Projector, Multimedia projector. • through visit of herbal garden © CHARUSAT 2012 Page 164 of 240 Outline of the Course (Theory): No. Unit Minimum No. of Contact Hours 04 Approx. weightage % 08 1 Nucleic Acids: 2 Porphyrin metabolism: 02 3 Genetic code and protein synthesis: 04 4 Vitamins: 03 5 Biological Oxidation 03 6 Nitrogen and Sulphur cycles 04 14 7 Clinical Biochemistry 10 30 30 Total 14 14 10 10 100% Detailed syllabus (Theory): No. Unit 1 Nucleic Acids: biosynthesis of nucleotides and nucleic acids, Minimum No. of Contact Hours 04 References 02 1,3,4,5 04 1,2,3,4,5,6 03 1,2,3,4,5,6 03 1,2,3,4,5,6 1,3,4,5 denovo synthesis of purine nucleotides, salvage pathway for purine biosynthesis, pyrimidine biosynthesis. 2 Porphyrin metabolism: importance in the body, properties and biosynthesis of porphyrins, synthesis of haemoglobin, disorders related to these metabolic pathways. 3 Genetic code and protein synthesis: genetic code, DNA structure and its replication, RNA types and structure, transcription and translation, post-translational modifications, regulation of these processes and inhibitors of translation, mutations, physical and mutagenesis or carcinogenesis and DNA repair mechanisms. 4 Vitamins: structure and biochemical function of fat-soluble and water-soluble vitamins. 5 Biological Oxidation: redox potential, enzyme and coenzyme involved in oxidation reduction and its control, respiratory chain, oxidative phosphorylation. © CHARUSAT 2012 Page 165 of 240 6 Nitrogen and Sulphur cycles: nitrogen fixation, ammonia 04 1,2,3,4,5,6 10 1,2,3,4,5,6 assimilation, nitrification and nitrate assimilation, sulphate activation, sulphate reducation, incorporation of sulphur in organic compounds, release of sulphur from organic compounds, 7 Clinical Biochemistry genetic disorders of carbohydrate, fat protein and nucleic acid metabolism. liver function test, kidney function test, advance diagnostic techniques PCR, radio immuno assay, ELISA, DNA finger print, immunofluorescence, electrophoresis, biosensors such as glucometer etc., marker enzymes and their diagnostic applications like lactate dehydrogenase, acetycholinestrase, phosphatase, amylase etc. Detailed syllabus (Practical): No. 1 Aim of the Practical Study of techniques like spectrophotometry, Reference centrifugation, 7,8,9,10,11 electrophoresis and different types of chromatography. 2 Extraction and purification of nucleic acids. 7,8,9,10,11 3 Gastric Juice Analysis: Bound and free. 7,8,9,10,11 4 Quantitative estimation of amino acids. 7,8,9,10,11 5 Quantitative estimation of proteins. 7,8,9,10,11 6 Quantitative estimation of serum glucose by various methods. 7,8,9,10,11 7 Quantitative estimation of serum creatinine, cholesterol, urea, etc 7,8,9,10,11 8 Quantitative estimation of SGOT, SGPT, BRN, etc. 7,8,9,10,11 9 Estimation of chloride content in the urine samples 7,8,9,10,11 © CHARUSAT 2012 Page 166 of 240 Recommended study materials: 1. Principles of Biochemsitry by A. L. Lehninger,, CBS Publishers and Distributors. 2. Harper's Biochemistry, Edited by R. K. Murry, D. K. Granner, P.A. Mayes and V. W. Rodwell, Prentice Hall International Inc., Latest Edition. 3. Biochemistry by S. C. Rastogi, Tata McGraw Hill, New Delhi, Latest Editon. 4. Biochemistry by U. Satyanarayana, Books and Allied (P) Ltd., Calcutta, Latest Edition. 5. Principles of Biochemsitry by G. F. Zubay, W. W. Parson and D. E. Vance, WBC Publishers, England, Latest Edition. 6. Principles of Biochemistry (Paperback), Robert Horton, Laurence A Moran, Gray Scrimgeour, Marc Perry and David Rawn. Pearson Education. 7. An Introduction to Practical Biochemistry by D. T. Plummer,, Tata McGraw Hill, New Delhi. 8. Laboratory Manual in Biochemistry, Willey, Eastern Limited, New Delhi. 9. Practical Biochemistry: Principles and Techniques, 5th ed. Cambridge : Cambridge University Press, 2003 10. Introductory Practical Biochemistry, Singh R. and Sawhney, S.K., New Delhi : Narosa Publishing House, 2002 11. P. G. Tikekar, Practical Biochemistry for medical students, Ed. 4 Publ. Mrs. Nalini. P. Tikekar, Bombay,1964. © CHARUSAT 2012 Page 167 of 240 BIOPHARMACEUTICALS (PH312) (Theory & Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the course: • To study the unique qualities of biological products in the way that they are derived and manufactured as opposed to other drug products. Students learning outcomes/objectives: • The course will help the students to have a good understanding of the preparation of biological products. • Students should be able to describe use and applications of various biological products. Instructional methods and pedagogy: • The faculty shall explain the lectures using black board, Over Head Projector or Multimedia projector. Outline of course: No. Unit Minimum No. of Approx. Contact Hours Weightage % Approx. 1 Blood products and plasma substitutes 2 Surgical Products 3 Immunological Preparations 4 Fermentation 5 Allergenic Extracts 6 Study of Diagnostic Aids Total © CHARUSAT 2012 8 18 7 15 9 20 8 18 6 14 7 45 15 100 Page 168 of 240 Detailed Syllabus (Theory): Sr. Unit Details No 1 Reference Numbers Book of Hours 2,5,10 8 1,2,10 7 4,7,9,10 9 Blood products and plasma substitutes: Collection, processing labeling and storage of whole human blood, concentrated human RBC, dried human plasma, human fibrinogen, human thrombin, human normal immunoglobulin, human fibrin foam, plasma substitutes-ideal requirements, PVP, dextran etc., control of blood products as per I.P and B.P. 2 Surgical Products: Definition, primary wound dressing, absorbent surgical cotton, surgical gauzes, bandages, adhesive tape, protective cellulosic hemostastics, official dressing, absorbable and nonabsorbable sutures, catgut. Standardization of surgical products, Packaging and labeling of surgical products in general. Medical prosthetics and organ replacement materials 3 Immunological Preparations: a) Immunology: A brief introduction to following terms: • Antigens • Immune system • Cellular & humoral immunity • Antigen & Antibody reactions • Active & Passive Immunity b) Immunological Preparations: • Vaccines: Preparation, Standardisation, storage, A brief study of following vaccines: tetanus toxoid, BCG, rabies, polio, typhoid, hepatitis vaccine, • Antibodies: Polyclonal & Monoclonal, Hybridoma technology for Monoclonal Antibodies © CHARUSAT 2012 Page 169 of 240 4 Fermentation: Screening of soil for organisms producing antibiotics, general screening methods, isolation and preservation of pure cultures. Mutants, factors influencing rate of mutation. Fermenter, its design, control of different parameters, design of fermentation process. media, sterilization (fermenter, media, air, etc.), 3,4,6,8 8 1,5 6 10 7 Isolation of fermentation products. Detailed production of 1. selected antibiotics: penicillins, streptomycins,tetracyclines 2. vitamin B12, Riboflavin 3. others: citric acid, alcohol 5 Allergenic Extracts: Types of allergy, allergens, diagnosis of allergy, sensitivity testing, and treatment of allergy, preparation, testing and standardisation of allergenic extracts. 6 Study of Diagnostic Aids Produced by Biotechnology Detailed Syllabus (Practical): Sr. No. Aims of Practical 1 Preparation of the anticoagulant solution. 2 Preparation of alcohol by fermentation. 3 Preparation of allergenic extracts 4 Standardization of vaccines 5 Preparation of bandage. 6 Isolation of mutant by gradient plate techqunie 7 Preparation of different pads 8 Preparation of Plaster of Paris © CHARUSAT 2012 Page 170 of 240 Recommended Study Materials: 1. Remington: The Science and Practice of Pharmacy,Vol I & II, Gennaro Alfonso R., Lippincott Williams & Wilkins, New York 2. Dispensing Pharmacy by Cooper & Gunn, Edited by S. J. Carter, CBS Publishers & Distributors, New Delhi. 3. Principles of Fermentation Technology, P. F. Stanbury, A. Whittaker, Aditya Books (P) Ltd., New Delhi. 4. Industrial Microbiology, Prescott and Dunn, CBS Publishers and Distributors, New Delhi. 5. Biopharmaceuticals: Biochemistry & Biotechnology, Gary Walsh, John Willey & Sons Inc., New York. 6. Industrial Microbiology, L. E. Casida, JR., New Age International Publishers, India. 7. Pharmaceutical Microbiology, Edited by W.B. Hugo and A.D. Rusell Blackwell Science, United Kingdom. 8. Fermentation Microbiology & Biotechnology, Edited by E. M. T. EL Mansi & C. F. A. Bryce, Taylor & Francis, New York. 9. Microbiology, M. J. Pelczar, JR., E.C.S. Chan and N. R. Krieg, Tata Mc Graw-Hill, Inc., New York. 10. Indian Pharmacopoeia 2007, Indian Pharmacopoeial Commission, Ghaziabad. Note: It is preferable to refer latest addition of all above mentioned books © CHARUSAT 2012 Page 171 of 240 BIOPHARMACEUTICS & PHARMACOKINETICS (PH313) (Theory) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) Objective of the course: • The course is designed to make students familiar with basic aspects of Biopharmaceutics & Pharmacokinetics of the drugs Students learning outcomes/objectives: • The course will help the student to have a good understanding of absorption, distribution, metabolism & elimination (ADME) process of drugs occur and various factors which influence on them in body. • Students should be able to learn Pharmacokinetics aspects of drugs and its significance Instructional methods and pedagogy: • The faculty shall explain the lectures using black board, Over Head Projector or Multimedia projector. Outline of course: No. Unit Minimum No. of Contact Weight age % Hours Approx. Introduction to Biopharmaceutics 1 3 7 and Pharmacokinetics 2 Biopharmaceutics 18 40 3 Pharmacokinetics 16 35 4 Bioavailability & Bioequivalence. 8 18 45 100 Total Detailed syllabus (Theory): Sr Unit Details no 1 Reference No. of Books Hours 1,8,9 3 Introduction to Biopharmaceutics and Pharmacokinetics History and their role in formulation development & therapeutics and clinical setting. © CHARUSAT 2012 Page 172 of 240 2 Biopharmaceutics: Physicochemical, biological and pharmaceutical factors affecting biopharmaceutical performance of drugs in ADME (Absorption, distribution, metabolism (biotransformation) and elimination a) Absorption of drugs: Passage of drugs across biological barrier by various mechanisms- passive diffusion, active transport, facilitated diffusion and pinocytosis, Factors influencing absorptionphysiochemical, physiological and pharmaceutical factors, absorption of drugs from non per oral system. b) Drug distribution: Factors affecting distribution, Volume of 1,2,3,4,5,7,8, 18 1,4,6,7,8, 16 distribution and its significance. Role of plasma proteins with respect to protein binding of drugs and its significance c) Metabolism of Drug: Factors affecting metabolism of drug, Phase I & Phase II reactions d) Excretion of drug: Mechanism of excretion, Factors affecting excretion e) Brief introduction to Biopharmaceutical Classification System (BCS) 3 Pharmacokinetics: a) Pharmacokinetics: Introduction, basic consideration Compartments model: Importance & applications. Significance of plasma drug concentration measurements. b) Pharmacokinetics and drug absorption: Zero order and first order c) Compartment kinetics: One compartment and two compartment models. Determination of pharmacokinetic Parameters (including absorption rate constant-Ka) from plasma & urine data after drug administration by Oral and I.V. route. Determination of Ka using Curve fitting (Method of Residuals), regression procedures, Wagner –Nelson and LOO Riegelman method. d) Clearance concept, mechanism of renal clearance, clearance ratio, determination of renal clearance. e) Hepatic elimination of drugs, first pass effect, extraction ratio, hepatic clearance, biliary excretion, extrahepatic circulation. i) Non linear Pharmacokinetics: A brief study of Non-liner pharmacokinetics with special reference to one compartment © CHARUSAT 2012 Page 173 of 240 model after I.V. drug administration, Michaels Mention Equation, detection of non linearity (Saturation mechanism) and application h) Clinical Pharmacokinetics : basic consideration 4 Bioavailability & Bioequivalence: a) concept and significance b) Measurements of bioavailability, Cmax, Tmax and area under curve (AUC). c) Design of single dose bioequivalence study & relevant statistics. 1,5,7,8 8 Regulatory requirements for conduction of bio- equivalent studies. d) Methods for enhancement of bioavailability e) Brief introduction to In Vivo In Vitro Correlation (IVIVC) Recommended Study Material: 1. Applied Biopharmaceutics & Pharmacokinetics, Leon Shargel, Mc Graw Hill, New York 2. Remington: The Science and Practice of Pharmacy, Gennaro Alfonso R., Vol I & II, Lippincott Williams & Wilkins, New York 3. Modern Pharmaceutics, Edited by G. S. Banker & C.T. Rhodes, Marcel Dekker inc. N.Y. 4. Principal and Application of Biopharmaceutics and Pharmacokinetics, Dr. H.P. Tipnis Amrita Bajaj, Career Publication. 5. Pharmaceutics: The science of dosage form design, Edited by M.E. Aulton, Churchill Livingstone, New York. 6. Pharmacokinetics, M. Gibaldi, D. Perrier, Marcel Dekker. New York. 7. Biopharmaceutics & Clinical Pharmacokinetics –An introduction, R.E. Notari, Marcel Dekker Inc.N.Y. 8. Biopharmaceutics & Pharmacokinetics, D. M. Brahmankar, S. B. Jayswal, Vallabh Prakashan, New Delhi 9. Biopharmaceutics & Pharmacokinetics by Venkateshwarlu, Pharama Book Syndicate, Hyderabad. Note: It is preferable to refer latest addition of all above mentioned books © CHARUSAT 2012 Page 174 of 240 PHARMACEUTICAL SOFTWARES (PH314) (Practical) Credits: 1.5 (Practical) Contact Hours per week: 3 (Practical) Objective of the Course: To prepare students to understand the basic applications of the softwares used in Pharmacy. Student Learning Outcomes / Objectives: To prepare student to use different softwares in pharmacy. Instructional Methods and Pedagogy: The faculty shall explain the lectures • Using black board, • Using Over Head Projector, Multimedia projector. • Using the computer softwares Detailed Syllabus (Practical): The exercise pertaining to the applications of following softwares may be assigned to the students by considering the utilization of software in field of pharmaceutical sciences. 1) Chem draw © • Drawing of 2D and 3D structures of small molecular weight compounds • IUPAC nomenclature 2) COREL DRAW © • Application of softwares in preparation of presentations e.g. poster, banners etc. 3) End Note © • Accessing database using end note • Application of end note in scientific documentation 4) Adobe Photoshop © • Application of software as image analysis and editing tool • Alteration of background and image modification as per set criterions 5) CHEMIX © • Application of software in drawing pseudo ternary diagram. 6) Excel © sheet Microsoft • Biostatistics • ANOVA, t-test, f-test, SD. RSD, SEM, Avarage, Correlation, regression, chi-square test • Data analysis using graphical method © CHARUSAT 2012 Page 175 of 240 PHARMACEUTICAL MANAGEMENT-I (MB301) (Theory) Credits: 2 (Theory) Contact Hours per week: 2 (Theory) Objective of the Course: This course is designed to allow the students to familiarize with basic management and economic aspects of business world and would facilitate understanding of some basic organizational processes. It also aims at helping students to learn the art of applying concepts of management to the real-life / contemporary situations. Student Learning Outcomes / Objectives: By the end of the course, students would have a good understanding of: • Various concepts of management, business and importance of other related activities of the management. • Learn important managerial skills so as to adapt to environmental changes. • Fundamental concepts of economics namely demand, supply and price. • Accounting terms and concepts including IT applications. Instructional Methods and Pedagogy: • • • • Interactive Lectures, Case Studies, Group Presentations, Applications and Problems. Outline of the Course (Theory): Module No. 1 2 3 4 5 Title/Topic Forms of Business Organisation Introduction to Management Understanding Economics Working with Accountancy Contemporary Issues in Pharmaceutical Management Total © CHARUSAT 2012 Number of Sessions 6 6 6 10 2 30 Approx. Weightage % 20 20 20 30 10 100% Page 176 of 240 Detailed Syllabus (Theory): Module No. Title/Topic 1 Forms of Business Organisation • Concept of Business • Types of Business Organisation namely Sole Proprietorship, Partnership, Company, Cooperative, etc. 2 Introduction to Management • Evolution of Management Thought • Concept of Management • Management Approaches / Process 3 Understanding Economics • Principles of Economics • Laws / Determinants of Demand and Supply • Costs of Production 4 Working with Accountancy • Principles of Accountancy • Ledger Posting, Book Entries, Trial Balance, Cash Book, BRS, Rectification of Errors, P & L A/c, Balance Sheet • Accounting Software – Tally, etc. 5 Contemporary Issues in Pharmaceutical Management • Issues, Challenges and Opportunities in Pharmaceutical Sector Total Recommended study materials: Number of Sessions 6 6 6 10 2 30 1. ‘Management’ – James Stoner, Edward Freeman, Deniel Gilbert Jr., - Prentice Hall of India, New Delhi, Sixth Edition 2. ‘Essentials of Management’, Koontz and Weihrich, Tata McGraw Hill, 2004. 6th Edition 3. Principles of Economics by N Gregory Mankiw; Publisher –Thomson SouthWestern. 4. Economics by John Solomon; Publisher: PHI 5. David Holt, Entrepreneurship – New Venture Creation, PHI 6. Paresh Shah (2009), Basic Accounting for Management, Oxford University Press 7. S N Maheshwari, S K Maheshwari (2008), A Text Book of Accounting for Management, Vikas Publishing • Newspapers, Magazines and Journals: 1. Indian Management 2. Harvard Business Review 3. Economic and Political Weekly 4. Journal of Accounting © CHARUSAT 2012 Page 177 of 240 Bachelor of Pharmacy Programme SYLLABI (Semester – 7) CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY © CHARUSAT 2012 Page 178 of 240 CLINICAL PHARMACY & PHARMACOTHERAPEUTICS-I (PH401) (Theory & Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the Course: To make students familiar with the principles of Clinical Pharmacy & Pharmacotherapy of disease. Student Learning Outcomes / Objectives: At the end of the course, the student will be able to understand the concept of Clinical Pharmacy & Pharmacotherapy. Clinical pharmacy is the new emerging branch of pharmacology from which student can understand role clinical pharmacist in association to Physician (hospital) & Patient. On the other hand Pharmacotherapy is the area under which, discussion of treatment & management of diseases& /or disorder. Instructional Methods and Pedagogy: Faculty member/s shall explain in a class room using black board and multimedia projector as well as case studies discussion. Outline of the Course (Theory): Sr. No. Unit Minimum No. of Contact Hours Approx. Weightage % 1 Introduction to Clinical Pharmacy 2 4 2 Basic concept of Pharmacotherapy 3 7 3 Drug interactions 3 7 4 General Principles of Clinical toxicology 2 4 5 Therapeutic Drug Monitoring 4 10 6 a) Pharmacovigilance b) Pharmacoepidemiology 4 7 Clinical laboratory tests and their interpretation 4 10 10 8 Clinical Presentation, Diagnosis, Complication & Management of 13 28 b) Renal Disorders 5 10 c) Hematological Disorders 3 6 d) Malignant Disorders 2 4 45 100 following Diseases/Disorders: a) Cardiovascular Disorders Total © CHARUSAT 2012 Page 179 of 240 Detailed syllabus (theory): Sr. No. 1 2 3 Name of Chapter Introduction to Clinical Pharmacy: Development and scope of clinical pharmacy, concept of health care team, Role and Functions of clinical pharmacist as a member of health care team. Basic concept of Pharmacotherapy : Recording of medication history, self medication, nonprescription drug usage, Communication skills of Clinical Pharmacist - Behavioral and interpersonal, with patients and other professionals Drug interactions: Prescription monitoring, documentation and methods for minimizing clinically relevant drug interactions. References 1,4,6 Hrs. required 2 1,4 3 1,3 3 4 General Principles of Clinical toxicology 1,3 2 5 Therapeutic Drug Monitoring for safety and efficacy (medication chart review, clinical review, pharmacist interventions) 4,6 4 6 a) Pharmacovigilance. - The role of clinical pharmacist in monitoring and prevention of Adverse Drug Reactions b)Concepts of Pharmacoepidemiology 1,3,5 4 7 Interpretation of clinical laboratory tests: Hematological, pathological and biochemical investigations as markers of Major organ damage and their effect on drug therapy decisions 5,7,8,9 4 8 Clinical presentation, Diagnosis, Complication & Management of following Diseases/Disorders. a) Cardiovascular Disorders: Hypertension, Angina Pectoris Myocardial Infarction, Congestive Heart failure, Cardiac arrhythmias, Atherosclerosis, Stroke b) Renal Disorders: electrolyte abnormalities, acid-base disorders, acute renal failure, chronic renal failure c) Hematological Disorders: Anemia. d) Malignant Disorders: ,Leukemia, Lymphoma and mammary carcinomas © CHARUSAT 2012 1,5,8,9,10 13 1,5,8,9,10 5 1,5,8,9,10 3 1,5,8,9,10 2 Page 180 of 240 Detailed syllabus (Practical): 1 Practical related to Drug information Center, Role of Clinical pharmacist & its role, Hospital visit ( different department ), Literature audit, Case studies 2 Pharmacoepidemiology and pharmacovigilance related practical. 3 Clinical laboratory tests & their interpretations (Actual data from hospital) 4 Prescription monitoring related to Polypharmacy & Drug interaction 5 Case studies based on Cardiovascular, Renal, Hematological and Malignant Disorders. For clinical pharmacy related practical, pre tested format of case studies will be given. Recommended study materials: (Latest edition) 1. Elements of Clinical Pharmacy: R.K Goyal, Parloop A.Bhatt & Mahesh D.Burande, B.S. Shah Prakashan. 2. Davidson’s Principles & Practice of Medicines:Churchill Livingstone Elsevier. 3. Handbook of Drug Interactions, A clinical & forensic Guide by Ashraf Mozayani: Humana Press. 4. A Textbook of Clinical Pharmacy Practice: G. Parthasarathi, Karin Nyfort-Hansen and Milap Nahata, Universities Press. 5. Basic & Clinical Pharmacology, Bertram G. Katzung, MC Graw Hill. 6. Basic Principles of Clinical Research & Methodology: SK Gupta, ICMI. 7. The Merck Manual of Diagnosis and Therapy. Mark H. Beers and Robert Berkow. Published by: Merck & Co.Inc., USA. 8. Clinical Pharmacy & Therapeutics, Roger Walker; Churchill Livingstone Publication. 9. Textbook of Therapeutics, Drug & Disease Management: Richard A. Helms, David J., Quan, Eric T Herfindal, Lippincott Williams & Wilkins. 10. Principles of Internal Medicine Vol. I & II by Harrison. 11. Guide to Good Prescribing: A Practical manual, WHO Action programme on Essential Drugs Geneva. © CHARUSAT 2012 Page 181 of 240 HERBAL DRUGS TECHNOLOGY-I (PH402) (Theory & Practical) Credits: 2 (Theory) Contact Hours per week: 2 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the Course: To make students familiar with holistic concept of medication and drugs used in traditional system of medicine and understand the safety aspects of plants used as medicine. Student Learning Outcomes / Objectives: The students are expected to • Understand the holistic concept of drug administration as explained in selected medicinal systems and also to study the pharmacognostic aspects, uses and pharmacological properties of traditional plant drugs. • To learn about uses of the herbal extracts in various cosmetic and herbal formulations. • To learn about various poisonous plants. Instructional Methods and Pedagogy: The faculty shall explain the lectures • using black board, • using Over Head Projector, Multimedia projector. • through visit of herbal garden Outline of the Course (Theory): No. Unit 1. The holistic concept of drug administration in traditional system of medicines Minimum No. of Contact Hours Approx. weightage % 4 10 2. Studies of traditional drugs 14 45 3. Controversial drugs in Ayurvedic system of medicine 5 20 4. Utilization of herbs and extracts in food and Cosmetic. 3 15 5. Poisonous plants 4 10 30 100% Total © CHARUSAT 2012 Page 182 of 240 Detailed syllabus (theory): Sr.No. Name of Chapter Reference Hrs. Required 1 The holistic concept of drug administration in traditional 11,14,17 4 Studies of traditional drugs, common vernacular names, 4,6,7,8, 14 botanical sources, morphology, chemical nature of chief 9,10,11,13, system of medicines, Introduction to ayurvedic preparation like Arishtas, Asavas, Gutikas, Tailas, Churnas, Lehyas & Bhasmas, Ghrita- their preparation and standardization. 2 Constituents, pharmacology, categories and common uses and 14,15,17 marketed formulations of following drugs: Amala, Satavari, Musali, Damvel, Bhilama, Karen, Nagod, Chitrak, Apamarg, Gokhru, Bhringraj, Arjuna, Methi, Guggal, Madhunashini, Shilajit, Pippali, Kapikachhu, Majith, Galo, Vaj. 3 Controversial drugs in Ayurvedic system of medicine with 9,10,12, special reference to Brahmi, Shankhpushpi, Punarnava and 13,14,15 5 Rasna. 4 Utilization of herbs and extracts in food and Cosmetic. 1,2,5,11, 3 14,16,17 5 Poisonous plants with special reference to Calotropis, Aconite, 11,18 Hemlock, Abrus precatorius and fungal toxins Detailed syllabus (Practical): Sr. No Aim of the Practical 1 Pharmacognostic study of Madhunashini. 2 Pharmacognostic study of Brahmi. 3 Pharmacognostic study of Satavari and Musali. 4 Pharmacognostic study of Chitrak. 5 Pharmacognostic study of Punarnava. 6 Pharmacognostic study of Shankhpushpi. 7 Estimation of Piperine in crude drug or formulation. 8 Estimation of Curcuminoids in crude drug or formulation. © CHARUSAT 2012 Page 183 of 240 4 9 Estimation of total cinchona alkaloids from cinchona bark. 10 Estimation of Sennoside in crude drug or formulation by UV spectrophotometric method. 11 Standardization of Ayurvedic formulation (Triphala churna). 12 Standardization of herbal formulation. Recommended study materials: 1. Cultivation and Utilization of Aromatic Plants. Edited by C.K. Atal and B.M. Kapoor R.R.L., Jammu- Tawi, 1982. 2. Cultivation and Utilization of Medicinal Plants. Edited by C.K. Atal and B.M. Kapoor R.R.L., Jammu- Tawi, 1982. 3. British Herbal Pharmacopoeia, 1983. Published by British Herbal Medicine Association, U.K. 4. Indian Herbal Pharmacopoeias, 1999. Vol. I and Vol. II. A Joint Publication of R.R.L. Jammu and IDMA, Mumbai. 5. Herbal Drug Industry. Chief Editor R.D. Chaudhary, 1st Edition, 1996. Eastern Publishers, New Delhi. 6. Compendium of Indian Medicinal Plants Vol. I, II, III, IV by R.P. Rastogi and B.N. Mehrotra, CDRL Lucknow, 1993. 7. The Useful Plants of India, 3rd Reprint, 1994. Pub. & Information Directorate CSIR, New Delhi. 8. The wealth of India. Raw Materials Revised. Edition 1985. Publication and Information Directorate, CSIR, New Delhi. 9. Indian Materia Medica. Edited by K.M. Naadkarni. Volume Iand II. Reprint 1996. Bombay Popular Parkashan. 10. Kiritkar K.R. and Basu B.D. Indian Medicinal Plants. Text Volume I, II, III and IV 1987. International Book Distributors, Dehradun. 11. Trease and Evans Pharmacognosy, 15th Edition, 2008. W.B. Saunders Company, Singapore. 12. Vaidya B. G. Some Controversial Drugs in Indian Medicine. 1st Edition, 1982. Chaukhaba Orientalia, Varanasi. 13. Ayurvedic medicinal plants, Kapoor L. D., CRC press, 1st Indian Reprint, 2005. © CHARUSAT 2012 Page 184 of 240 14. The ayurvedic Formulary of India, Part I and II, Department of Indian system of Medicine and Homoeopathy, Govt, of India, 1st English Edition, 2000. 15. Pharmacognosy of Ayurvedic drugs, Kerala Series, volume 1 to 10. 16. Herbal drug technology, S. S. Agrawal and M. Paridhavi, Univeristies Press, 1st Edition, 2007. 17. Pharmacognosy: C.K.Kokate, A.P.Purohit, S.B.Gokhale, Nirali prakashan, Pune, 39th Edition, 2007. 18. Toxic plants and other natural toxicants, Tam Garland et al., CABI publishing, 1999. © CHARUSAT 2012 Page 185 of 240 MEDICINAL CHEMISTRY-III (PH403) (Theory) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) Objective of the course: • The course is designed to make students familiar with the principles of medicinal chemistry as applied to pharmaceuticals and to study the synthetic approaches and structure activity relationship of different therapeutic class of drugs. Students learning outcomes/objectives: • By the end of this course, the student should have a good understanding of the basic concepts of novel approaches of Medicinal chemistry • Students should be able to describe in detail novel synthetic approaches, mechanisms of action and recent advances in drug design as well as Quantitative Structure Activity Relationship of some important therapeutic class of Drugs. • The course may help the students in understanding rational approaches towards the design of important therapeutic agents and their biological implications. Instructional methods and pedagogy: • Using blackboard and one-way communication from a teacher to a student. • Using an overhead and LCD projector Outline of the course (Theory): No. Unit Minimum No. of Approx. Contact hours. Weightage % 1 Strategies in the search for new lead compounds 07 16 2 QSAR 15 32 3 Introduction to structure and ligand based drug design 08 18 4 The following classes of drugs will be discussed in relation to: Introduction to the rational and recent development of the drug (if any) including • Chemical classification (if any) • Chemical nomenclature • Mechanism of action • Synthesis of the agent mention in the bracket • Structure activity relationship • Therapeutic 15 34 45 100 % Total © CHARUSAT 2012 Page 186 of 240 Detailed syllabus (Theory): No Unit Minimum Referen No. of ces Contact Hours 1 Strategies in the search for new lead compounds: introduction, 07 1,2,3 4,5,6,7 15 1,2,3 4,5,6,7 08 1,2,3 4,5,6,7 15 1,2,3 improvement of existing drugs, systematic screening including extensive screening, random screening and high-throughput screening, screening of synthetic intermediates, selective optimization of side activities (SOSA) approach, new use for old drugs – an illustrative study with suitable examples. 2 QSAR: introduction, SAR versus QSAR, various QSAR methods, linear regression and multiple linear regression analysis, Hansch analysis, FreeWilson analysis, mixed approach, parameters used in QSAR, experimental and theoretical approaches for the determination of physicochemical parameters, statistical significance and interpretation of QSAR models, prediction of novel potent molecule, 2D QSAR, 3D QSAR- examples, CoMFA and CoMSIA. 3 Introduction to structure and ligand based drug design: structure based drug design, requirement of SBDD, understanding of drugreceptor/enzyme/target interactions, preparation of protein/target along with active site analysis, docing process, various docking methods, Denove drug design and ligand based drug design. 4 The following classes of drugs will be discussed in relation to: Introduction to the rational and recent development of the drug (if any) including • Chemical classification (if any) • Chemical nomenclature • Mechanism of action • Synthesis of the agent mention in the bracket • Structure activity relationship • Therapeutic Drugs acting on Cardio Vascular System • Antihypertensives (guanethidine, bretylium tosylate, hedralazine hydrochlorid, propranolol, atenolol) • Antiarrhythmic agents © CHARUSAT 2012 Page 187 of 240 • • • Antianginal agents Antihyperlipidemic agents Cardiotonics • Diuretics(chlorothiazide,hydroflumethiazide,benzthiazide, furosamide, ethacrynic acid, acetazolamide) • Anticoagulants, thrombolytics, platelet aggregation inhibitors (aspirin) Recommended Study Material: 1. Wilson and Giswold's Textbook of Organic, Medicinal and Pharmaceutical Chemistry,J. N. Delagado and W. A. R. Remers, Eds, J. Lipponcott Co. Philadephia. 2. Principles of Medicinal Chemistry by W. C. Foye,, Lea & Febiger, Philadelphia. 3. Burger's Medicinal Chemistry, H. E. Wolff, Ed. John Wiley & Sons, New York Oxford University Press, Oxford. 4. Strategies for Organic Drug Synthesis & Design by Daniel Lednicer, John Wiley & sons, USA. 5. Smith & William’s Introduction to the Principle of Drug Design and Action,4th Edition, H. John Smith, Eds,CRS Press-Taylor & Francis Group, USA. 6. Text book of Drug Design & Discovery, 3rd Edition, Povl Krogsgaard-Larsan, Tommy Liljefors & ULF Madsen, Eds, Taylor & Francis Group, USA. 7. Walter Sneader’s Drug Discovery-A History, John Willy & Sons, Ltd. UK. 8. Comprehensive Medicinal Chemistry II: Volume 4: COMPUTER-ASSISTED DRUG DESIGN (Hardcover), By: Jonathan S Mason (Editor),More About this Product, Pub. By:Elsevier Science & Technology,2006 © CHARUSAT 2012 Page 188 of 240 PHARMACEUTICAL ANALYSIS – III (PH404) Credits: 3 (Theory) : 1.5 (Practical) (Theory & Practical) Contact Hours per week: 3 (Theory) : 3 (Practical) Objective of the course: • The course is designed to make students familiar with the principles of instrumental Analytical chemistry as applied to pharmaceuticals and to study the qualitative and quantitative estimation of active constituents into a different pharmaceutical dosage forms Students learning outcomes/objectives: • By the end of this course, the student should have a good understanding of the basic concepts of instrumental Analytical chemistry • Students should be able to describe in detail different instrumental spectroscopy as well as basic concept of qualitative and quantitative estimation. • The course may help the students in understanding rational approaches towards the different chromatography techniques for separation of active constituents. • Instructional methods and pedagogy: • Using blackboard and one-way communication from a teacher to a student. • Using an overhead and LCD projector Outline of the Course (Theory): No. Unit Minimum No. of Contact Hours 10 Approx. weightage % 1 Ultraviolet/Visible Molecular Absorption Spectroscopy 2 Infrared Spectrometry 07 16 3 Molecular Luminescence Spectrometry 05 10 4 Quantitative Thin – Layer Chromatography 03 08 5 High Performance Liquid Chromatography (HPLC) 12 26 6 Gas Chromatography 08 16 45 100% Total © CHARUSAT 2012 24 Page 189 of 240 Detailed syllabus (Theory): Unit Sr. No. 1 Ultraviolet/Visible Molecular Absorption Minimum References No. of Contact Hours 10 3,4,5,7,10 Spectroscopy: electromagnetic radiation – its properties and absorption by molecules, factors affecting absorption of radiation by molecules, Beer’s Law and its deviations, Beer’s & Lambert’s Law instrumentation, sample handling techniques and pharmaceutical applications and recent advancement. 2 Infrared Spectrometry: introduction, instrumentation (components 07 2,3,4,6,7 05 1,3,4,9 03 1,4,8 12 1,4,9,11,12 and their general working principles), sample handling, a brief introduction to fourier transform infrared spectroscopy (FTIR) and ATR, applications and recent advancement, analytical shortcomings. • 3 Introduction to raman spectroscopy Molecular Luminescence Spectrometry: theory of Fluorescence and Phosphorescence, Factors affecting the intensity of chemiluminescence’s, Instrumentation and analytical applications and recent advancement. 4 Quantitative Thin – Layer Chromatography: introduction, HPTLC, Quantitation – scraping and elution, visual comparison, area management, densitometry and thermal methods, applications and recent advancement. 5 High Performance Liquid Chromatography(HPLC): introduction, theory – migration equation, theoretical plate, columns and stationary phases, measurement of column performance and its optimization, instruments for liquid chromatography including column packing for various types of chromatography, Classification and Principle of HPLC, mobile phase characteristics for normal and reversed phases, polarity and selectivity of the solvents, Instrumentation (including significance of guard column), scope and applications. Brief introduction to hyphenated techniques like LC-MS, LC-MS-MS, etc • Basic principle, theory and applications of partition, adsorption, ion-exchange, size exclusion, Super critical fluid and Affinity © CHARUSAT 2012 Page 190 of 240 chromatography. 6 08 Gas Chromatography: introduction, principles of Gas – Liquid 1,4,9 chromatography, instrumentation, columns and stationary phases, qualitative and quantitative applications in pharmaceuticals, brief introduction to hyphenated techniques like GC-MS etc Detailed syllabus (Practical): Sr. No. 1 2 Reference Aim of the Practical List of Requirement. 13 Standards of Tablets and Capsules as per IP’2007. 13 To perform weight variation of content of active ingredient test for given 13 Chloramphenical capsules IP’2007. To perform weight variation and content uniformity test for active ingredient for 3 13 Atenolol as per IP’2007. 4 To perform assay of Mefenemic acid as per IP’2007. 13 5 To interpret the given IR spectra. 8 To perform assay of Calcium gluconate injection as per IP’2007. 13 6 To perform the assay of Isoniazide tablet as per IP’96. 7 To find out content of active ingredient of Metformine tablet as per IP’2007. 13 8 To perform the assay of active ingredient for Riboflavin as per IP’2007. 13 9 To find out concentration of Na+ ion from given sample using flame photometer. 8 10 To perform content uniformity test for Paracetamol as per IP’2007. 13 11 To perform uniformity test for Co- trimoxzole as per IP’92007. 13 To perform the TLC of given Sample mixture. 8 12 Demonstration of HPTLC 13 To perform the assay of Paracetamol by HPLC (demonstration). 8 14 To perform the assay of quinine sulphate by fluorimeter. 8 15 To study the effect of quenching on quinine sulphate by KI 8 © CHARUSAT 2012 Page 191 of 240 Recommended study materials: 1. Principles of Instrumental Analysis, Skoog, Hollar and Nieman, Saunders college Publishers, Philadelphia. 2. Spectroscopic identification of organic compounds. R.M. Silverstein, G.C. Bassler, T.C. Morrill Pub: John Wiley and Sons, NY. 3. Instrumental Methods of Analysis, Willard, Merritt, Dean and Settle, CBS publishers and Distributers, Delhi. 4. Instrumental Methods of Chemical Analysis, BK Sharma, Goel Publication House, Meerut, Second Edition- 2001 India. 5. Instrumental Methods of Chemical Analysis, 3rd ed, G. W. Ewing, McGraw Hill Book Co, NY-1969. 6. Organic Spectroscopy, W. Kemp, 3rd ed, ELBS publication, NY, 1991. 7. Applications of Absorption Spectroscopy of Organic compounds J. R. Dyer, Prentice Hall, London 8. Practical Pharmaceutical Chemistry, Part I & II, A. H. Beckett & J. B. Stenlake, CBS 9. Introduction of Instrumental Analysis, Robert Braun, McGraw-Hill: New York 10. Spectroscopy of Organic Compounds, P S Kalsi, New Age International Publishers. 11. Introduction to High Performance Liquid chromatography, R. J. Hamilton, Chapman and hall, London 12. Munson JW. High performance liquid chromatography: Theory, instrumentation, and pharmaceutical applications. In; Pharmaceutical analysis modern methods part B, New York, Marcel Dekker. 13. Pharmacopoeia: USP, B.P., I.P. © CHARUSAT 2012 Page 192 of 240 DOSAGE FORM DESIGN (PH405) (Theory & Practical) Credits: 2 (Theory) : 1.5 (Practical) Contact Hours per week: 2 (Theory) : 3 (Practical) Objective of the course: • The course is designed to make students familiar with basic parameters which are important to design of pharmaceutical dosage forms Students learning outcomes/objectives: • The course will help the student to have a good understanding of preformulation and stability aspects of various dosage forms. • Students should be able to learn in detail about role of various excipients used in various formulations Instructional methods and pedagogy: • The faculty shall explain the lectures using black board, Over Head Projector or Multimedia projector. Outline of course: No. Unit Minimum No. of Contact Weight age % Hours Approx. 1 Preformulation studies 8 27 2 Stability of pharmaceuticals 8 27 3 Pharmaceutical necessities 8 27 Dissolution Studies 6 19 Total 30 100% (Adjuvants/Excipients) 4 Detailed syllabus (Theory): Sr Unit Details no 1 Reference No. of Books Hours 1,4,5,13 8 Preformulation studies: a) Study of physical properties of drug like physical form, particle size, shape, density, wetting, dielectric constant, solubility, dissolution & organoleptics property & their effect on formulation, stability & bioavailability. © CHARUSAT 2012 Page 193 of 240 b) Crystal Characteristics: Crystalline structures, polymorphic nature of drugs, methods to identify polymorph (XRD, DSC studies) c) Drug-Excipient compatibility studies & the role of DSC and FTIR techniques to evaluate compatibility 2 Stability of pharmaceuticals: a) Kinetic principles & stability testing: Reaction rate and order. Product stability: Requirements, Shelf life, overages, containers, closures. b) Pathway of drug degradation and stabilization techniques: Hydrolysis, oxidation, reduction, racemization, 1,2,3,6,7 8 1, 8,10 8 9,11, 12, 6 polymerization, acid base catalysis etc. and their influence on formulation and stability of products. c) A Brief introduction to ICH guidelines, Accelerated stability testing procedures. Stability protocols for various pharmaceutical products. 3 Pharmaceutical necessities (Adjuvants/Excipients) Anti- oxidants, preservatives, colours, flavours, Diluents, binders, disintergrants, antifrictional agents, emulsifiers, suspending agents, ointment bases, solvents etc. 4 Dissolution Studies: Introduction, theory of dissolution, apparatus, interpretation of results, Effect of micromeritics on dissolution of oral solid dosage forms, A brief study of application of statistical treatment of dissolution data. An overview of different pharmacopoeial dissolution test apparatus with respect to IP, BP & USP © CHARUSAT 2012 Page 194 of 240 Detailed syllabus (Practicals): Sr no. 13. Aim of Practical Design Preformulation protocol for given drug including drug excipient compatibility studies. 14. To evaluate different glidants for the given formula of tablet. 15. To evaluate best binder for given formula of tablet. 16. Study the effect of diluents on tablet formulation. 17. To evaluate the effect of different concentration of disintegrating agents on various tablet formulation 18. To prepare calamine lotion with different concentration of suspending agents and evaluate various parameters with respect to Physical stability. 19. Study about co-solvency for various solutes using PG, PEG & glycerin as co-solvent with water as solvent. 20. To prepare solid dispersion of Paracetamol using PEG 4000 as carrier and study dissolution of paracetamol in pure form and from solid dispersion. 21. Study dissolution behavior of Paracetamol tablet (marketed formulation) 22. Study stability of ascorbic acid in given solution at given temperature. 23. To study the Stability of aspirin at given temperature. 24. To study the effect of pH on solubility of drugs. Recommended Study Materials: 1. The Theory & Practice of industrial pharmacy, Leon Lachman, Lea & Febiger, Varghese Publication House Bombay. 2. Remington: The Science and Practice of Pharmacy, Gennaro Alfonso R., Vol I & II, Lippincott Williams & Wilkins, New York 3. Modern Pharmaceutics, Edited by G. S. Banker & C.T. Rhodes, Marcel Dekker inc. N.Y. 4. Pharmaceutics: The science of dosage form design, Edited by M.E. Aulton. Churchill Livingstone, New York. 5. Ansel’s Introduction to Pharmaceutical Dosage Form and Drug Delivry system, H.C. Ansel, N.G. Popovich, Lippincott Williams and wilkins, Philadelphia. 6. Drug Stability, edited by J. T. Cartensen, C.T.Rhode, Marcel Dekker Inc. N.Y. 7. Martin’s Physical Pharmacy and Pharmaceutical Science, P.J. Sinko, Lippincott Williams & wilkins, Philadelphia. © CHARUSAT 2012 Page 195 of 240 8. Handbook of Pharmaceutical Excipients, edited by R.C. Rowe, P.J. Sheskey, M. E. Quinn, 6th edition American Pharmacists Association & The Royal Pharmaceutical Society of Great Britain, USA 9. Pharmaceutical Dissolution testing, U. V. Banakar, Marcel Dekker Inc. 10. Pharmaceutical dosage forms: Tablets, H.A. Lieberman, Leon Lachman, Vol.: 1, 2, 3, Marcel Dekker inc. N.Y. 11. Indian Pharmacopoeia, 2007 , published by Indian Pharmacopoeial commission, Ghaziabad 12. United State Pharmacopoeia, 2004, Indian edition, United State Pharmacopoeial convention INC. 13. Advance in controlled & Novel drug delivery system, edited by N.K.Jain , CBS Publication, New Delhi Note: It is preferable to refer latest addition of all above mentioned books © CHARUSAT 2012 Page 196 of 240 PHARMACEUTICAL TECHNOLOGY-I (PH406) (Theory & Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the course: • The course is designed to make students familiar with the formulation, manufacturing and quality related issues of different non sterile dosage forms. Students learning outcomes/objectives: • The course will help the student to have a good understanding of the preparation of tablet and tablet coating, capsules & semisolid dosage forms. • Students should be able to describe in detail instrumentation /equipments for both preparation and evaluation of final product as per standards • Students should be able to describe good manufacturing practices and their utilization during preparation of products. • Students should be able to describe the packaging materials for pharmaceutical products and their requirement. Instructional methods and pedagogy: • The faculty shall explain the lectures using black board, Over Head Projector or Multimedia projector. Outline of course: No. Unit Minimum No. of Contact Weight age % Hours Approx. 1 Tablet and Tablet coating 10 22 2 Capsules 7 16 3 Micro encapsulation 6 13 4 Semisolid dosage forms 10 22 5 Other Solid Dosage Forms 2 4 6 Container, closures, packaging & 7 16 3 7 45 100 labeling for pharmaceutical products 7 GMP (Schedule M) Total © CHARUSAT 2012 Page 197 of 240 Detailed Syllabus (Theory): Sr. Unit Details No 1 Reference Numbers Book of Hours 1,4,5,7,8,9 10 1,4,5,6,7,8,9 07 Tablet: a) Definition, Advantages, Disadvantages, b) Formulation of tablets diluents, disintegrants, Binder, Adsorbent, Lubricants, antiadherents, glidants, organolaptic additives: colors, flavors and sweetening agents, co processed excipients. c) Granulation methods and its influence on physical and mechanical properties, compression behaviour, Direct compression, d) Tablet Presses, e) Problems and remedies. f) Evaluation (Pharmacopoeial and non- pharmacopoeial tests) with special emphasis on dissolution curve comparison , g) process flow sheets Tablet coating: Objectives, Film (aqueous, non- aqueous, pseudo latex coating), Sugar and compression coating, Methods, Equipments and Design of coating pan, defects of coated tablets and their remedies. 2 Capsules: Hard Capsules- Definition, Advantages, Disadvantages, Ideal Requirements, Production of hard capsules (gelatin and non- gelatin e.g. vegetable capsules), Capsules storage, Size of capsules, Formulation and methods of capsules filling, Problems and remedies, Climate control in capsules departments, I.P. products. Soft gelatin capsules (SGCs)- Formulation of shell and capsule core, Quality control. © CHARUSAT 2012 Page 198 of 240 3 Microencapsulation- Importance of microcapsules in pharmacy, methods of preparation: phase separation coacervation, multi orifice centrifugal method, spray congealing, polymerization, air suspension technique, coating pan and other technique, evaluation 1,4,5,7,8,9 06 1,2,7,8,9,10 10 2,3,5,6 2 7,8,9, 10,11 7 12 3 of microcapsules. 4 Semisolid dosage forms: Definitions, advantages & disadvantages, ideal requirements, types, mechanisms of drug penetration, factor influencing penetration through skin, Bases and their selection. General formulation of semi solids, clear gels, manufacturing procedure, evaluation and packaging, I.P. Products. 5 Other Solid Dosage Forms: Effervescent Granules and Powders. An overview of Extrusion-Spheronization, Palletization Technology and its applications. 6 Container, closures, packaging & labeling for pharmaceutical products : 7 • Labeling requirements • metal, glass, plastic container • Rubber closures & pilfer proof caps • blister & strip packing GMP (Schedule M) Detailed syllabus (Practicals): Sr. No. 1. A B 2. A B 3. A B 4. 5. 6. 7. A B 8. A Aim of Practical Demonstration of Rotary Tablet Machine. To Prepare and evaluate paracetamol tablet. Demonstration of tablet coating machine To Prepare and evaluate Aspirin effervescent tablet. To Prepare and evaluate calcium lactate tablet. Demonstration of tablet dissolution apparatus, friability apparatus and tablet disintegration apparatus. To Prepare and evaluate Chewable tablet. To Prepare methyl salicylate gel To Prepare & Evaluate fast dissolving tablet To Prepare & Evaluate microspheres Demonstration of Bottle, Vial, and Ampoules Washing Machine. Demonstration of operation procedure of hand operated Capsule Filling Machine © CHARUSAT 2012 Page 199 of 240 B 9. 10. 11. 12. To Determine the appropriate size of capsule To Prepare zinc oxide and iodine ointment Study of different types of packaging for solid, liquid, semisolid and parenteral products. Preparation & Evaluation of Sodium Alginate Pellets To prepare BMR (Batch Manufacturing Record) & BPR (Batch Packaging Record) for given dosage forms Recommended Study Material: 1. The Theory & Practice of industrial pharmacy by Leon Lachman, Lea & Febiger, Varghese Publication House Bombay. 2. Remington’s Pharmaceutical Sciences , Ed. A. R. Gennaro, Mack Publishing Co, 3. Modern Pharmaceutics, Edited by G. S. Banker & C.T. Rhodes, Marcel Dekker inc. N.Y. 4. Pharmaceutical dosage forms: Tablets, Vol.: 1, 2, 3, H.A. Lieberman, Leon, Lachman, Marcel Dekker inc. N.Y. 5. Pharmaceutics: The science of dosage form design, Edited by M.E. Aulton. Churchill Livingstone, New York. 6. Ansel’s Introduction to Pharmaceutical Dosage Form and Drug Delivry system, H.C. Ansel, N.G. Popovich, Lippincott Williams and wilkins, Philadelphia. 7. Indian Pharmacopoeia, 2007 , published by Indian Pharmacopoeial commission, Ghaziabad 8. United State Pharmacopoeia, 2004, Indian edition, United State Pharmacopoeial convention INC. 9. British Pharmacopoeia 2004, British Pharmacopoeia commission office, U.K. 10. Packaging of Pharmaceutical and Healthcare Product, H. Lockhart and F.A. Paine, Blackle Academic and Professional, Glasgow. 11. Pharmaceutical Packaging Technology edited by D.A. Dean, E. R. Evans, Taylor and Francis, New York. 12. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control, Sidney H. Willig, James R. Stoker Marcel Dekker Inc, New York Note: It is preferable to refer latest addition of all above mentioned books © CHARUSAT 2012 Page 200 of 240 PHARMACEUTICAL MANAGEMENT–II (MB401) (Theory) Credits: 2 (Theory) Contact Hours per week: 2 (Theory) Objective of the Course: This course is designed to enable the students to familiarize with various important functions of business management like marketing, human resources, and operations. It also aims at helping students to learn the art of personal selling and inventory management. By the end of the course, students would have a good understanding of: • Various functions of management and other related activities. • Learn important sales skills required for effective selling. Student Learning Outcomes / Objectives: By the end of the course, students would have a good understanding of: • Various concepts of management, business and importance of other related activities of the management. • Learn important managerial skills so as to adapt to environmental changes. • Fundamental concepts of economics namely demand, supply and price. • Accounting terms and concepts including IT applications. Instructional Methods and Pedagogy: • • • • Interactive Lectures, Case Studies, Group Presentations, Applications and Problems. Outline of the Course (Theory): Module No. 1 2 3 4 5 Title/Topic Entrepreneurship Functional Areas of Business: Marketing Financial Management Human Resources Management Operations Management Total © CHARUSAT 2012 Number of Sessions 6 6 6 10 2 30 Approx. Weightage % 20 20 20 30 10 100% Page 201 of 240 Detailed Syllabus (Theory): Module No. 1 2 Number of Sessions 6 Title/Topic Entrepreneurship • Meaning, Concept and Types of Entrepreneurship • Entrepreneurship and Innovation • Personal attributes for entrepreneurial success Functional Areas of Business: Marketing • Introduction to Marketing / Research • Essentials of Pharmaceutical Marketing o Marketing Mix Elements 6 o Product and Pricing Decisions o Channels of Distribution, Physical Distribution and Logistics • 3 4 5 o Sales Promotion, Steps, Types, etc. Sales Management o Principles, Process and Importance of Personal Selling o Sales Territory & Quotas Financial Management • Need and Sources of Finance • Working Capital Management Human Resources Management • Manpower Planning (Concept of Job Analysis, Specification and Description) • Recruitment, Selection, Placement, Performance Appraisal, Training and Development • Wages / Salary / Remuneration Administration Operations Management • Concept / Types of Production Processes • Selection of Location, Site, Plant, Layout, etc. • Production, Planning and Scheduling (PPC) • Total Quality Management (TQM) • Inventory Management o Concepts, Types, Techniques, etc. Total 6 6 6 30 Recommended study materials: 5. Kotler, Keller, Koshy, Jha (Latest), Marketing Management: A South Asian Perspective, Pearson Education 6. Ashwathappa, Human Resource Management, Tata MacGraw Hill 7. Russell, Taylor, Operations Management, Pearson 8. Prasanna Chandra, Financial Management, TMH Newspapers, Magazines and Journals: 1. Indian Management 2. Harvard Business Review 3. Journal of Entrepreneurship 4. Journal of Marketing 5. HRM Review 6. Industry Reports, etc. © CHARUSAT 2012 Page 202 of 240 ELECTIVE - I PHARMACEUTICAL INSTRUMENTATION & TECHNOLOGY-I (PH407.01) Credits: 1.5 Contact Hours per week: 3 Objective of the Course: To make students familiar with different machineries used in pharmaceutical industry for manufacturing of dosage form Student Learning Outcomes / Objectives: The students are expected to • Learn the theoretical aspects of the different machines used in pharmaceutical production and formulation development • To enable students to prepare comparative data sheet for purchase of pharmaceutical machineries Detailed Syllabus: Study of design, working and applications of following machineries used in manufacturing and development of pharmaceutical dosage forms • Rotary tablet compression machine • Tablet coating machine • Capsule filling machine • Spray dryer Instructional Methods and Pedagogy: Every week, a three hour slot to be allocated for the course. During this three hour slot, first hour may be allocated for theoretical principles while rest of two hours shall be allocated to practicals to be performed A group of 4-5 students may handle a single machine per practical Projects can be based on o Practicals related to operating machine and preparing drug formulation o Practicals related to documentation, SOP Preparations, Purchase related technical evaluation o Preparing a Review Document and Presentation based on recent advances in particular machine and novel applications © CHARUSAT 2012 Page 203 of 240 The faculty shall explain 1. Using black board, notes, company manuals 2. By providing practicals and projects related to machine handling 3. Using Over Head Projector, Multimedia projector. Evaluation Scheme & Guidelines: The evaluation shall comprise of total 100 marks, 80 marks university level evaluation and 20 marks institute level evaluation Institute will announce the schedule of examination in consultation with university (same as practical exams) Institute level evaluation of 20 marks will comprise of journals, attendance, mid-term project report, presentations, practical performances, quizzes, case-analysis, viva, synopsis, and/or descriptive questions. University evaluation of 80 marks will comprise of projects, presentations, practical performances, quizzes, case-analysis, viva, synopsis, and/or descriptive questions. Recommended Books/Journals/Websites: 1. Remington: The Science and Practice of Pharmacy, Gennaro Alfonso R., Lippincott Williams & Wilkins, New York 2. The Theory & Practice of Industrial Pharmacy; Lachman L., Lieberman H.A., Kanjig J.L., Varghese Publishing House, Bombay; 3rd edition; 1991. 3. Encyclopedia of Pharmaceutical Technology, Informa Healthcare, Latest Edition 4. Journals/Magazines – PharmaTimes, PharmaBuzz, PharmaWorld 5. Technical Literatures from various companies involved in designing and manufacturing of Pharma Machineries (available on websites) 6. Website: Contractpharma.com © CHARUSAT 2012 Page 204 of 240 ELECTIVE-I PHARMACEUTICAL DOCUMENTATION-I (PH407.02) Credits: 1.5 Contact Hours per week: 3 Objective of the Course: To make students familiar with different documentation practices followed in pharmaceutical industry. Student Learning Outcomes / Objectives: The students are expected to learn preparations of various documents involved in pharmaceutical industry in departments of analysis, formulation, production, and administration Detailed syllabus: List of Practicals: To prepare Standard Operating Procedure for following machines o Rotary tablet compression machine o Capsule filling Machine To prepare Standard Operating Procedure for cleaning Class 100 Area To prepare comparative data-sheet of Certificate of Analysis (CoA) for small molecules, biomolecules and API and understand importance of each parameters mentioned in CoA Autoclave – Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) o To prepare an installation qualification protocol (IQ Protocol) o To prepare an operational qualification protocol (OQ Protocol) o To prepare performance qualification protocol (PQ Protocol) To prepare Analytical method validation protocol To prepare Master formula record (MFR) and study Batch formula record (BFR) for any two formulations To study Validation Master Plan for Sterile Dosage Manufacturing Unit To study Specification and Method of analysis protocol for any one API To study In process quality control (IPQC) protocol © CHARUSAT 2012 Page 205 of 240 Instructional Methods and Pedagogy: Every week, a three hour slot to be allocated for the course. During this three hour slot, first hour may be allocated for theory while rest of two hours shall be allocated to practicals to be performed The faculty shall explain 1. using black board, notes, government documents 2. By providing practicals and projects 3. Using Over Head Projector, Multimedia projector. Evaluation Scheme & Guidelines: The evaluation shall comprise of total 100 marks, 80 marks university level evaluation and 20 marks institute level evaluation Institute will announce the schedule of examination in consultation with university (same as practical exams) Institute evaluation of 20 marks will comprise of journals, attendance, mid-term project report, presentations, practical performances, quizzes, case-analysis, viva, synopsis, and/or descriptive questions. University evaluation of 80 marks will comprise of projects, presentations, practical performances, quizzes, case-analysis, viva, synopsis, and/or descriptive questions. Recommended Books/Journals/Websites: 1. Guidance for the Preparation of Standard Operating Procedures. U.S. EPA, EPA-QA G-6. 2. SOP guidelines: Electronic data management, D. H. Shah, Published by Business horizons, 2nd edition 3. Pharmaceutical Process Validation, by Robert Nash, Mercel Dekker, 2003 4. http://pharmapedia.wikidot.com/certificate-of-analysis-guide-for-bulkpharmaceutical-excipients 5. CGMP-a good manufacturing practice for pharmaceuticals, Manohar Potdar, Pharma med press, 2008 6. A WHO guideline to CGMP requirements: Part 2 Validation 7. Validation in Pharmaceutical Industry (Concept, Approches & Guidelines), P.P.Sharma, Vandhana Publications, New Delhi 8. http://inorganicventures.com/tech/guides/consumer/certificate-of-analysis-parts 9. FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices and Biologics, 2nd ed. – Douglas J. Pisano and David S. Mantus © CHARUSAT 2012 Page 206 of 240 ELECTIVE-I PHARMACEUTICAL MARKETING-I (PH407.03) Credits: 1.5 Contact Hours per week: 3 Objective of the Course: To make students familiar with marketing practice followed in pharmaceutical industry. Student Learning Outcomes / Objectives: The students are expected to o Learn the skills of marketing to promote the sale of drug products and pharmaceuticals. Detailed syllabus: Sr. Topic No 1 Understanding Marketing Management 2 The Importance of Marketing Fundamental Marketing Concepts, Trends, and Tasks. The Scope of Marketing in Pharmaceuticals Markets. Company orientations towards the marketplace Capturing Pharmaceuticals marketing insights Analyzing pharmaceutical business markets Identifying market segments and targets Ethics in Pharmaceutical Marketing Pharmaceutical Brand Management and Market offerings Brand Equity and brand positioning Designing product and pricing strategy Instructional Methods and Pedagogy: Every week, a three hour slot to be allocated for the course. During this three hour slot, first hour may be allocated for theory while rest of two hours shall be allocated to practicals/projects to be performed The practical comprises of preparing marketing plan for domestic/international sales, case-analysis, field work, presentations, etc. © CHARUSAT 2012 Page 207 of 240 The faculty shall explain 1. Using black board, notes, etc. 2. By conducting practicals and projects 3. Using Over Head Projector, Multimedia projector. Evaluation Scheme & Guidelines: The evaluation shall comprise of total 100 marks, 80 marks university level evaluation and 20 marks institute level evaluation Institute will announce the schedule of examination in consultation with university (same as practical exams) Institute evaluation of 20 marks will comprise of journals, attendance, mid-term project report, presentations, practical performances, quizzes, case-analysis, viva, synopsis, and/or descriptive questions. University evaluation of 80 marks will comprise of projects, presentations, practical performances, quizzes, case-analysis, viva, synopsis, and/or descriptive questions. Recommended Books/Journals/Websites: 1. Marketing Management: A South Asian Perspective, Kotler, Keller, Koshy, Jha, Pearson Education 2. Marketing Strategies by Saxena Rajan, Tata-McGraw Hill, latest edition 3. Marketing Management: Indian context by Ramaswami, Namakumari, Macmillan India. 4. Marketing Management by Kumar Arun, Meenakshi, Vikas Publishing, Latest Edition 5. Indian Journal of Marketing, 6. Marketing Master Mind, etc. 7. www.pharmaceuticals.gov.in 8. www.cdsco.nic.in 9. www.nppaindia.nic.in 10. www.gujhealth.gov.in 11. www.pharmexcil.org 12. www.mims.com/India © CHARUSAT 2012 Page 208 of 240 Bachelor of Pharmacy Programme SYLLABI (Semester – 8) CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY © CHARUSAT 2012 Page 209 of 240 CLINICAL PHARMACY & PHARMACOTHERAPEUTICS-II (PH408) (Theory & Practical) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the Course: To make students familiar with the principles of Clinical Pharmacy & Pharmacotherapy of disease. Student Learning Outcomes / Objectives: At the end of the course, the student will be able to understand the concept of Clinical Pharmacy & Pharmacotherapy. Clinical pharmacy is the new emerging branch of pharmacology from which student can understand role clinical pharmacist in association to Physician (hospital) & Patient. On the other hand Pharmacotherapy is the area under which, discussion of treatment & management of diseases& /or disorder. Instructional Methods and Pedagogy: Faculty member/s shall explain in a class room using black board and multimedia projector as well as case studies discussion. Outline of the Course (Theory): Sr. No. Minimum No. of Contact Hours Unit 1 Patient counseling 2 2 Concept of essential drugs and Rational use of medicines. 2 3 Pharmacoeconomics 3 4 Drugs used in special population 5 5 Concept of acute care medicine 2 6 Introduction to Clinical Research 2 7 Clinical Presentation, Diagnosis, Complication & Management of following Diseases/Disorders: 6 a) CNS Disorders b) Endocrine Disorders 5 5 6 12 5 5 12 11 5 c) Musculoskeletal Disorders 6 3 d) Infectious Diseases 8 e) Gastrointestinal Disorders 18 9 4 f) Respiratory Disease: 6 3 Total © CHARUSAT 2012 Approx. Weightage % 45 100 Page 210 of 240 Detailed syllabus (theory): Sr. No. 1 Name of Chapter Patient counseling (to improve patient compliance on References Hrs required 4 2 appropriate drug use) 2 Concept of essential drugs and Rational use of medicines. 4,8 2 3 Pharmacoeconomics: 8 3 1,6,8,9 5 9,12 2 11,8 2 1,2,4,6,7,9 6 Cost benefit analysis, cost effectiveness analysis, cost minimization analysis, cost utility analysis 4 Drugs used in special population: Pediatric, Geriatric and pregnant women. 5 Concept of acute care medicine: Managing ICUs, TPN & emergencies 6 7 Introduction to Clinical Research: - Types of clinical research - Phases of clinical research a) CNS Disorders: Epilepsy, Parkinsonism, Schizophrenia, Depression, Insomnia, Anxiety, Migraine etc b) Endocrine Disorders: Pancreas , Thyroid, Parathyroid, 1,2,4,6,7,12 5 Adrenal c) Musculoskeletal Disorders: Rheumatoid arthritis, Gout 1,2,4,6,7,9 3 & Hyperuricemia. d) Infectious Diseases: 1,2,4,6,7, 9,12 Tuberculosis, Urinary Tract Infections, Enteric infections, upper 8 respiratory tract infections, Meningitis, Malaria, sexually transmitted diseases(STDs) and AIDS, e) Gastrointestinal Disorders: Peptic ulcer disease, Inflammatory Bowel Disease, Hepatitis, Cirrhosis f) Respiratory Disease: Asthma & COPD © CHARUSAT 2012 1,2,4,6,7,9,12 4 1,2,4,6,7,9,12 3 Page 211 of 240 Detailed syllabus (Practical): 1 Therapeutic Drug Monitoring Case studies 2 Pharmacoeconomics related practical. 3 Case studies related to Pediatrics, Geriatrics & pregnancy. 4 Case studies based on CNS, Endocrine, Musculoskeletal, Infectious and Gastrointestinal Disease, Respiratory Disease. For clinical pharmacy related practical, pre tested format of case studies will be given. Recommended study materials :( Latest edition) 1. Textbook of Therapeutics, Drug & Disease Management: Richard A. Helms, David J., Quan, Eric T Herfindal, Lippincott Williams & Wilkins. 2. Davidson’s Principles & Practice of Medicines:Churchill Livingstone Elsevier. 3. Pathology and Therapeutics for pharmacists: A basis for clinical pharmacy practice, Greene and Norman, Pharmaceutical press. 4. Basic & Clinical Pharmacology,Bertram G. Katzung, MC Graw Hill. 5. Foundations of Clinical Drug therapy:Anne Collins Abrams, Lippincott Williams & Wilkins. 6. Clinical Pharmacy & Therapeutics, Roger Walker; Churchill Livingstone Publication. 7. Principles of Internal Medicine Vol. I & II By Harrison. 8. A Textbook of Clinical Pharmacy Practice: G. Parthasarathi, Karin Nyfort-Hansen and Milap Nahata, Universities Press, 2004 9. Elements of Clinical Pharmacy:R.K Goyal, Parloop A.Bhatt & Mahesh D.Burande, B.S. Shah Prakashan. 10. Handbook of Drug Interactions, A clinical & forensic Guide by Ashraf Mozayani: Humana Press. 11. Basic Principles of Clinical Research & Methodology: SK Gupta, ICMI. 12. The Merck Manual of Diagnosis and Therapy. Edited by Mark H. Beers and Robert Berkow. Published by: Merck & Co.Inc., USA. © CHARUSAT 2012 Page 212 of 240 HERBAL DRUGS TECHNOLOGY-II (PH409) (Theory) Credits: 2 (Theory) Contact Hours per week: 2 (Theory) Objective of the Course: To make students familiar with the advanced applications of herbs as drugs and also with regulatory guidelines world wide for the control and trade of herbal medicine. Student Learning Outcomes / Objectives: The students are expected to • To understand the techniques to develop the plant tissue culture and implementation of the method in research along with its advantages and limitations. • To familiar with the current regulatory situation prevailing worldwide to control the utilization of herbal drugs. • To understand the spectral approach to elucidation of the structure of some low molecular weight simple phytoconstituents along with stereochemistry of the selected compounds and its impact on the biological activities exhibited. Instructional Methods and Pedagogy: The faculty shall explain the lectures • using black board, using Over Head Projector, Multimedia projector. • through visit of herbal garden Outline of the Course (Theory): No. Unit 1. Plant Tissue Culture 2. Marine Pharmacognosy and recent medicines from natural origin. 3. Spectral approach to structure elucidation of different classes of phytoconstituents. Minimum No. of Contact Hours 7 Approx. weightage % 5 15 4 15 20 4. Concept of stereoisomerism taking example of natural compounds. 3 10 5. Regulatory guidelines in herbal drugs. 3 10 6. WHO Guidelines for standardization of herbal drugs. 3 10 7. Introduction to Chromatographic methods in Pharmacognosy. 5 20 Total 30 100% © CHARUSAT 2012 Page 213 of 240 Detailed syllabus (theory): Sr.No. Name of Chapter Reference Hrs. Required 1 Plant Tissue Culture- Techniques of initiation and 1,2,4, maintenance of various types of cultures. Immobilized cell 15,16 7 culture and biotransformation studies including recent development in production of biological active constituents in static, suspension and hairy root cultures. 2 a) Marine Pharmacognosy, novel medicines from marine 1,2,4,14,15 5 Spectral approach to structure elucidation of different classes 2,3,8,9, 4 of phytoconstituents. 10,11,13 Concept of stereoisomerism taking example of natural 2,3,8,9, compounds. 10,11,13 Introductory studies on regulatory conditions prevailing 5,6,12, world wide for controlling the utilization and trade of herbal 14,16,17 Sources. b) Recent molecules of medicinal importance from natural origin with special reference to Forskolin, Taxol, Artemisinin, Cannabinoids, Hypericin and Silymarin. 3 4 5 3 3 drugs and herbal products. Standardization of herbal drugs. 6. WHO Guidelines for standardization of herbal drugs. 14,16 3 7. Introduction to applications of various Chromatographic 1,2,5,7, 5 methods for separation and analysis of various classes of 12,14,16 phytoconstituents. © CHARUSAT 2012 Page 214 of 240 Recommended study materials: 1. Pharmacognosy and pharmacobiotechnology, Ashutosh Kar, New Age International (P) Ltd, Publishers, 2nd edition 2007. 2. Trease and Evan’s Pharmacognosy: W. C. Evans, W.B.Saunders Co., Singapore, 15th Edition 2008. 3. Chemistry of Organic Natural Products, Vol. I and II, O. P. Agrawal, Goel Publishing House, 31st Edition, 2005. 4. Pharmacognosy and Phytochemistry, Part I and II, Vinod D. Rangari, Carrier Publications, 1st Edition, Reprint, 2007. 5. Quality Standards of Indian Medicinal Plants, Volume I and II, A. K. Gupta, ICMR, 2003. 6. Quality Control of Herbal Drugs: Mukherji P. K., Business Horizon Pharma. Publishers, 1st Edition, 2002. 7. Herbal drug technology, S. S. Agrawal and M. Paridhavi, Univeristies Press, 1st Edition, 2007. 8. Organic Chemistry of Natural Products Volume I and II: Chatwal G., 7th Reprint 1998, Himalaya Publishing House, Mumbai. 9. Organic Chemistry, Volume- 2, Steriochemistry and the chemistry of Natural Products: Finar I.L., Fifth Edition, 1996, ELBS Publication. 10. Medicinal Natural Products. A biosynthetic Approach: Dewick P., 2nd Edition, 2001, John Willey and Sons. 11. Text Book of Medicinal Chemistry of Natural Products: Pandeya S. A, S G Publishers, 1st Edition, 2007. 12. Indian Herbal Pharmacopoeia, Published by Indian Drugs Manufacturers’ Association, Revised new Edition, 2002. 13. Chemistry of Natural Products, S. V. Bhat et al., Narosa publications,Delhi, reprint 2008. 14. Pharmacognosy: C.K.Kokate, A.P.Purohit, S.B.Gokhale, Nirali prakashan, Pune, 39th Edition, 2007. 15. Method in Plant tissue culture by U. Kumar Agro botanica 1999. Bikaner India. 16. Quality control methods for medicinal plant materials, W.H.O., Geneva, A.I.T.B.S. Publishers and distributors, 1st Indian Edition, 2002. © CHARUSAT 2012 Page 215 of 240 MEDICINAL CHEMISTRY-IV (PH410) (Theory & Practical) Contact Hours per week: 3 (Theory) Credits: 3 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the course: • The course is designed to make students familiar with the principles of medicinal chemistry as applied to pharmaceuticals and to study the synthetic approaches and structure activity relationship of different therapeutic class of drugs. Students learning outcomes/objectives: • By the end of this course, the student should have a good understanding of the basic concepts of Medicinal chemistry • Students should be able to describe in detail synthetic approaches, mechanisms of action as well as structure activity relationship of some important therapeutic class of Drugs. • The course may help the students in understanding rational approaches towards the design of important therapeutic agents and their biological implications. Instructional methods and pedagogy: • Using blackboard and one-way communication from a teacher t o a student. • Using an overhead and LCD projector Outline of the course (Theory): No. Unit 1 2 The following classes of drugs will be discussed in relation to: Introduction to the rational and recent development of the drug (if any) including • Introduction • Chemical classification (if any) • Chemical nomenclature • Mechanism of action • Synthesis of the agent mention in the bracket • Structure activity relationship • Therapeutic Uses Combinatorial Chemistry 3 Introduction to recent advances in drug design Total © CHARUSAT 2012 Minimum No. of Approx. Contact hours. Weightage % 35 78 06 12 04 10 45 100 % Page 216 of 240 Detailed syllabus (Theory): No. Unit 1 The following classes of drugs will be discussed in relation to: Introduction to the rational and recent development of the drug (if any) including • Introduction • Chemical classification (if any) • Chemical nomenclature • Mechanism of action • Synthesis of the agent mention in the bracket 1.1 Minimum No. of Contact Hours • Structure activity relationship • Therapeutic Uses • Sulphonamides and fluoroquinolones (sulphanilamide, sulphacetamide, sulphaguanidine, sulphathiazole, sulphadiazine, sulphafurazole, sulphamerizine, Reference 1,2,3 22 1,2,3 13 1,2,3 sulphamethoxazole) • Antimalarials (chloroquin, primaquin, amodiaquin, mepacrin hydrochloride, pyrimethamine) • Antimycobacterials (Antileprotic & Antitubercle agents) (isoneazid, para amino salicylic acid, pyrazinamide, ethambutol, ethionamide, prothionamide, meprazinamide) • Antifungal agents (metronidazole, fluconazole) • Antiviral drugs including Anti-HIV drugs (amantadine) • Antineoplastic agents (methotrexate, chlorambucil, mustine, thio TEPA, cyclophospomide, 6-merceptopurine, hydroxyl urea) • Immunosuppressive agents • Antiamoebic and Anthelmentic agents (piperazine, diethyl carbamazine citrate, thiabendazole, pyrantel, niclosamide) • 1.2 Antiseptics and Disinfectants Antibiotics: β-lactams, aminoglycosides, tetracyclines, macrolides, polyene & polypeptide antibiotics, chloramphenicol. (ampicillin carbenicillin, cephalexin, penicillin-V, chloramphenicol) © CHARUSAT 2012 Page 217 of 240 2 Combinatorial Chemistry: introduction, principle, importance of new drug discovery, various synthetic approaches and library Purification. 06 1,2,3 4,5,6,7 3 Introduction to recent advances in drug design: quantitative structure pharmacokinetic relationship (QSPR), bioinformatics, genomic & proteomics 04 1,2,3 4,5,6,7 Detailed Syllabus (Practical): Topic No. 1 2 Aim of the Practical Referen ces Organic spotting of binary mixtures of solid + solid ,solid + liquid and liquid + liquid type of mixtures along with identification of the type of mixture, chemical separation, identification of the individual components, establishment of the identity of the separated components with the help of derivative preparation and TLC.(Minimum 7) 1. Synthesis of 5,5 diphenyl hydantoin from benzil and urea. 8,9,10,11 8,9,10,11 2. Synthesis of sulphanilamide from acetanilide. 8,9,10,11 3. Synthesis of Aspirin from acetyl salicylic acid by Microwave synthesis approach 4. Synthesis of paracetamol from p-aminophenol 8,9,10,11 8,9,10,11 5. Synthesis of Magnasone-II from p-nitro aniline and a-naphthol 8,9,10,11 Recommended Study Material: 1. Wilson and Giswold's Textbook of Organic, Medicinal and Pharmaceutical Chemistry,J. N. Delagado and W. A. R. Remers, Eds, J. Lipponcott Co. Philadephia. 2. Principles of Medicinal Chemistry by W. C. Foye,, Lea & Febiger, Philadelphia. 3. Burger's Medicinal Chemistry, H. E. Wolff, Ed. John Wiley & Sons, New York Oxford University Press, Oxford. 4. Strategies for Organic Drug Synthesis & Design by Daniel Lednicer, John Wiley & sons, USA. 5. Smith & William’s Introduction to the Principle of Drug Design and Action, 4th Edition, H. John Smith, Eds,CRS Press-Taylor & Francis Group, USA. 6. Text book of Drug Design & Discovery, 3rd Edition, Povl Krogsgaard-Larsan, Tommy Liljefors & ULF Madsen, Eds, Taylor & Francis Group, USA. 7. Walter Sneader’s Drug Discovery-A History, John Willy & Sons, Ltd. UK 8. Vogel’s Text book of Practical Organic Chemistry, ELBS/ Longman, London. 9. Practical Organic Chemistry by Mann & Saunder,, Orient Longman, London. 10. Spectormetric identification of Organic compounds by R. M. Silverstein, G. Claytron Bassel's and T. C. Movvill, John Wiley & Sons, USA. 11. Practical Organic Chemistry by Hitesh Raval, Sunil Baldania and Dimal Shah, First Edition, Nirav & Rupal Prakashan. © CHARUSAT 2012 Page 218 of 240 PHARMACEUTICAL ANALYSIS - IV (PH411) (Theory) Credits: 3 (Theory) Contact Hours per week: 3 (Theory) Objective of the course: • The course is designed to make students familiar with the principles of instrumental Analytical chemistry as applied to pharmaceuticals and to study the qualitative and quantitative estimation of active constituents into a different pharmaceutical dosage forms Students learning outcomes/objectives: • By the end of this course, the student should have a good understanding of the basic concepts of instrumental Analytical chemistry • Students should be able to describe in detail different instrumental spectroscopy as well as basic concept of qualitative and quantitative estimation. • The course may help the students in understanding rational approaches towards the different chromatography techniques for separation of active constituents. Instructional methods and pedagogy: • Using blackboard and one-way communication from a teacher to a student. • Using an overhead and LCD projector Outline of the Course (Theory): No. Unit Minimum No. of Contact Hours 15 Approx. weightage % 1 Nuclear Magnetic Resonance Spectroscopy 2 Molecular Mass Spectroscopy 10 22 3 Atomic Absorption and Atomic Emission Spectroscopy 07 16 4 X – Ray Crystallography 10 22 5 Super critical fluid chromatography 003 45 08 Total © CHARUSAT 2012 32 100% Page 219 of 240 Detailed syllabus (Theory): Sr. No. 1 Unit Nuclear Magnetic Resonance Spectroscopy: introduction, Minimum No. of Contact Hours 15 References 1,2,3,4,5,7,8,9 10 1,2,3,4,5,7,8,9 07 1,3,6,7 10 1,2,4 03 1,2,9 magnetic properties of nuclei, origin of NMR spectrum, environmental effects on NMR spectra, NMR spectrometers – instrumentation and sample handling, applications of proton NMR, brief introduction to application of NMR to other nuclei(C13 NMR) and recent advancements like(DEPT, HETCOR, NOE and COSY). 2 Molecular Mass Spectroscopy introduction, spectrometers origin – of mass spectra, ion sources, mass instrumentation, applications and recent advancement. 3 Atomic Absorption and Atomic Emission Spectroscopy: introduction, origin of atomic absorption & atomic emission spectra, instrumentation, qualitative and quantitative application of flame photometry and recent advancement. 4 X – Ray Crystallography introduction, X-ray absorption and X-ray diffraction methods, instrumentation for relevant instruments, applications and recent advancement. 5 Super critical fluid chromatography: introduction, supercritical fluids, instrumentation, supercritical mobile phase and application and recent advancement. Recommended study materials: 1. Principles of Instrumental Analysis, Skoog, Hollar and Nieman, Saunders college Publishers, Philadelphia. 2. Spectroscopic identification of organic compounds. R.M. Silverstein, G.C. Bassler, T.C. Morrill Pub: John Wiley and Sons, NY. 3. Instrumental Methods of Analysis, Willard, Merritt, Dean and Settle, CBS publishers and Distributers, Delhi. © CHARUSAT 2012 Page 220 of 240 4. Instrumental Methods of Chemical Analysis, 3rd ed, G. W. Ewing, McGraw Hill Book Co, NY-1969. 5. Organic Spectroscopy, W. Kemp, 3rd ed, NY, 1991. 6. Applications of Absorption Spectroscopy of Organic compounds J. R. Dyer, Prentice Hall, London 7. Introduction of Instrumental Analysis, Robert Braun, McGraw-Hill: New York 8. Spectroscopy of Organic Compounds, P S Kalsi, New Age International Publishers. 9. Mass Spectroscopy, Jurgen H. Gross, Springer Verlag, New York. © CHARUSAT 2012 Page 221 of 240 PHARMACEUTICAL TECHNOLOGY - II (PH412) (Theory & Practical) Credits: 2 (Theory) Contact Hours per week: 2 (Theory) : 1.5 (Practical) : 3 (Practical) Objective of the course: • The course is designed to make students familiar with the formulation, manufacturing and quality related issues of different sterile dosage forms, Aerosol products, liquid oral dosage forms and cosmetics. Students learning outcomes/objectives: • The course will help the student to have an understanding of the preparation of Parenteral products and their evaluation. Instructional methods and pedagogy: • The faculty shall explain the lectures using black board, Over Head Projector or Multimedia projector. Outline of course: No. Unit Minimum No. of Weightage % Contact Hours Approx. Sterile Dosage Forms 8 27 2. Pharmaceutical Aerosols 7 23 3. Cosmetology and Cosmetic preparation 5 17 4. Liquid Dosage Forms 8 27 5. Pilot Plant Scale up: An overview 2 06 30 100 1. Total © CHARUSAT 2012 Page 222 of 240 Detailed syllabus (Theory): Sr. Unit Details No 1 Reference Numbers of Hours Sterile Dosage Forms: a) Design and requirements for sterile products manufacturing facility: i) Environmental controls: quality of air, HEPA filters and laminar flow, class 100,1000,10000 area, monitoring of Areas ii) Requirements of Aseptic Area b) Flow plan for manufacturing of sterile products by terminal sterilization process c) Flow plan for manufacturing of sterile products by Aseptic Process d) Introduction to form fill seal (FFS) technology. e) Sterile Products for Injection: i. Large volume parenterals (LVP) ii. Small Volime parenterals (SVP) iii. Sterile Suspension iv. Sterile emulsion v. Sterile dry powders vi. Sterile solutions vii. Containers & closures for sterile products viii. Evaluation of sterile products f) Sterile products for ophthalmic 1,2,3,4 Application: Introduction, Ophthalmic Products: classification, formulation and preparation of eye drops, ophthalmic suspension, eye lotion, ophthalmic ointments, contact lens solutions. Solid inserts for ocular drug delivery (erodable & non erodable), advancement in ophthalmic delivery system including intra ocular dosage forms; containers and closures. © CHARUSAT 2012 Page 223 of 240 8 2 Pharmaceutical Aerosols: Definition, Advantages, disadvantages, Design of Aerosol: liquefied gas system, compressed gas system, barrier packs, components of aerosol, propellants: properties, classification, container for aerosol, valve assembly and components of valve, manufacturing: cold 1,2,5,6 7 10,11,12 5 1,3,7,8,9,13 8 1 2 and pressure filling technique, Quality control tests, stability, physicochemical & biological evaluation. Dry powder and meter dose valve, meter dose inhaler 3 Cosmetology and Cosmetic preparation: Fundamentals of cosmetic science, structure and function of skin and hair. Formulation, preparation and packaging of products such as Nail Preparation, Dental Products, Lipstick, Skin care products, Shampoo, shaving cream 4 Liquid Dosage Forms: Solution: methods of enhancing solubility, vehicles, A. formulation components: additives (solubilizers, antioxidants, sweeteners, preservatives, colors, flavors. Manufacturing and filling methods, evaluation of liquids: color, odor, taste, clarity testing. B. Suspension: definition, ideal requirements, formulation (Vehicle, suspending agents, antioxidants, preservatives, flocculating and deflocculating agents, wetting agents), approaches to formulation, manufacturing: equipments and process, flow sheets. Evaluation of suspension: zeta potential, particle size, density, rheological characteristics, organoleptic characteristics. C. Emulsion: Definition, emulsion types, formulation: choice of aqueous phase and oil phase, choice of emulsifiers, other additives (antioxidants, preservatives, colors, flavors, sweeteners), manufacturing: equipments and process, flow sheets. Evaluation: types of emulsion, stability evaluation. 5 Pilot Plant Scale up: An overview © CHARUSAT 2012 Page 224 of 240 Detailed syllabus (Practicals): Sr no Aim of Practical A. Demonstration of ampoules filling and sealing machine 1. B. Preparation of emulsion by different methods A. Preparation and evaluation Dextrose Injection. 2. B. Demonstration of Bottle Sealing Machine. A. Preparation and evaluation Ascorbic acid Injection. 3. B. Preparation and evaluation of paracetamol suspension. 4. Preparation and evaluation Calcium Gluconate Injection. 5. Preparation and evaluation Caffeine citrate injection. 6. Preparation and evaluation diclofenac sodium injection 7. Preparation of emulsion and to evaluate different parameters of quality of emulsion 8. Preparation of A. Vanishing Cream B. Clear Shampoo C. Cream Shampoo Preparation of 9. A. Face Powder B. Lather Shaving Cream C. Foam Shaving Cream Preparation of 10. A. Lipstick B. Nail Polish C. Nail Polish Remover Preparation of 11. A. Tooth Powder B. Tooth Paste 12. A To Prepare emulsion and find out the type of emulsion by measuring different evaluation parameter. B 13 Preparation of eye drops & eye ointment Preparation of A. Cleansing Cream B. Cleansing Lotion C. Cold Cream © CHARUSAT 2012 Page 225 of 240 Recommended study materials: 1. The Theory & Practice of industrial pharmacy, Leon Lachman, Lea & Febiger, Varghese Publication House Bombay. 2. Remington’s Pharmaceutical Sciences , Edited by A. R. Gennaro, Mack Publishing Co, 3. Modern Pharmaceutics, Edited by G. S. Banker & C.T. Rhodes, Marcel Dekker inc. N.Y. 4. Pharmaceutical dosage forms: Parenteral, Vol.: 1, 2, 3, Leon, Lachman, K. E. Avis, Marcel Dekker inc. N.Y. 5. Pharmaceutics: The science of dosage form design, Edited by M.E. Aulton. Churchill Livingstone, New York. 6. Ansel’s Introduction to Pharmaceutical Dosage Form and Drug Delivry system, H.C. Ansel, N.G. Popovich, Lippincott Williams and wilkins, Philadelphia. 7. Indian Pharmacopoeia, 2007 , published by Indian Pharmacopoeial commission, Ghaziabad 8. United State Pharmacopoeia, 2004, Indian edition, United State Pharmacopoeial convention INC. 9. British Pharmacopoeia 2004, British Pharmacopoeia commission office, U.K. 10. Cosmetic- Formulation, Manufacturing and Quality control, P. P. Sharma, Vandana Publication Pvt. Ltd., New Delhi. 11. Cosmetic Science and technology, Vol-1-3, M. S. Blsam, Wiley India Pvt. Ltd. 12. Poucher’s Perfumes, Cosmetics and Soaps, Edited by Hilda Butler, Springer, U.K. 13. Pharmaceutical dosage forms: Disperse systems, Vol.: 1, 2, 3, H.A. Lieberman, G. S. Banker , Marcel Dekker inc. N.Y. Note: It is preferable to refer latest addition of all above mentioned books © CHARUSAT 2012 Page 226 of 240 NOVEL DRUG DELIVERY SYSTEM (PH413) (Theory) Credits: 2 (Theory) Contact Hours per week: 2 (Theory) Objective of the course: • The course is designed to make students familiar with various novel & advanced drug delivery systems to overcome the problems of conventional delivery systems Students learning outcomes/objectives: • The course will help the student to have a good understanding of fundamentals of controlled drug delivery systems & their various types in detail • Students should be able to learn about targeted drug delivery systems & its significance Instructional methods and pedagogy: • The faculty shall explain the lectures using black board, Over Head Projector or Multimedia projector. Outline of course: Unit No. Minimum No. of Contact Weight age Hours Approx. % 1 Controlled drug delivery system 6 20 2 Oral controlled drug delivery system 6 20 3 Vesicular & Particulate Delivery 5 17 systems 4 Transdermal drug delivery systems 5 17 5 Immediate release delivery systems: 4 13 4 13 30 100% An overview 6 Drug targeting Total © CHARUSAT 2012 Page 227 of 240 Detailed Syllabus (Theory): Sr Unit Details no 1 Reference No. of Books Hours 4,6,7,8 6 3,6,7,8,10 6 5,9 5 2,3,6,7 5 2,10 4 5, 6,9, 4 Controlled drug delivery system: Fundamentals of modified/controlled drug delivery systems: Fundamentals, rational of modified release drug delivery, classification, factors influencing the design of controlled release dosage form including physicochemical factors. 2 Oral controlled drug delivery system: Classification, Design and development of oral controlled release dosage forms: Matrix, hydrogels, ion exchange, osmotic pressure controlled, gastro retentive delivery system 3 Vesicular & Particulate Delivery systems: Liposomes, niosomes, microparticles & nanoparticles 4 Transdermal drug delivery systems: Various approaches, Formulation using various technologies, Iontophorosis, Sonophorosis, Micro needle array 5 Immediate release delivery systems: An overview 6 Drug targeting: Need for drug targeting, Active & Passive targeting, various approaches for targeted drug delivery including ADEPT, Monoclonal Antibodies, Redox Mechanism, Nanoparticles, Liposomes etc.) Recommended Study Materials: 1. Modern Pharmaceutics, Edited by G. S. Banker & C.T. Rhodes, Marcel Dekker inc. N.Y. 2. Pharmaceutics: The science of dosage form design, Edited by M.E. Aulton. Churchill Livingstone, New York. 3. Ansel’s Introduction to Pharmaceutical Dosage Form and Drug Delivery system, H.C. Ansel, N.G. Popovich, Lippincott Williams and wilkins, Philadelphia. 4. The Theory & Practice of industrial pharmacy, Leon Lachman, Lea & Febiger, Varghese Publication House Bombay. 5. Progress in Controlled & Novel Drug Delivery System, N.K.Jain , CBS Publication, New Delhi 6. Novel drug delivery systems Fundamentals & Developmental concepts by Y.W.Chien, Marcel Dekker Inc. 7. Controlled drug Delivery, Fundamentals & application by J.R. Robinson & Univent Lee, Marcel Dekker Inc. © CHARUSAT 2012 Page 228 of 240 8. Biopharmaceutics & Pharmacokinetics, D. M. Brahmankar & S. B. Jayswal, Vallabh Prakashan, New Delhi 9. Targeted & controlled drug delivery, S.P.Vyas, R.K. Khar, CBS Publisher, India 10. Encyclopedia of Pharmaceutical Technology, edited by James Swarbrik, James Braylan, Vol-1, 2,3, Marcel Dekker inc. N.Y. Note: It is preferable to refer latest addition of all above mentioned books © CHARUSAT 2012 Page 229 of 240 Elective II (PHARMACEUTICAL INSTRUMENTATION & TECHNOLOGY-II) (PH414.01) Credits: 1.5 Contact Hours per week: 3 Objective of the Course: To make students familiar with different instruments used in pharmaceutical industry for drug analysis Student Learning Outcomes / Objectives: The students are expected to • Learn the theoretical aspects of the different instruments used in analysis of drugs and dosage forms • Prepare comparative data sheet for technical evaluation of pharmaceutical instruments for the purpose of purchase Detailed syllabus: Study of design, working, applications of following instruments used in pharmaceutical analysis • High performance Liquid Chromatography (HPLC) • High performance Thin Layer Chromatography (HPTLC) • Gel electrophoresis • BIOPAC system (Data Acquisition System) Instructional Methods and Pedagogy: Every week, a three hour slot to be allocated for the course. During this three hour slot, first hour may be allocated for theoretical principles while rest of two hours shall be allocated to practicals to be performed A group of 4-5 students may handle a single instrument per practical Projects can be based on o Practicals related to analysis of drugs/API/Dosage Forms using above mentioned instrument o Practicals related to documentation, SOP Preparations, Purchase related technical evaluation, Pharmacopoeial Assay © CHARUSAT 2012 Page 230 of 240 o Preparing a Review Document and Presentation based on recent advances and/or novel applications for a particular instrument. The faculty shall explain 1. Using black board, notes, etc 2. By conducting practicals and projects 3. Using Over Head Projector, Multimedia projector, etc Evaluation Scheme & Guidelines: The evaluation shall comprise of total 100 marks, 80 marks university level evaluation and 20 marks institute level evaluation Institute will announce the schedule of examination in consultation with university (same as practical exams) Institute evaluation of 20 marks will comprise of journals, attendance, mid-term project report, presentations, practical performances, quizzes, case-analysis, viva, synopsis, and/or descriptive questions. University evaluation of 80 marks will comprise of projects, presentations, practical performances, quizzes, case-analysis, viva, synopsis, and/or descriptive questions. Recommended Books/Journals/Websites: 1. Instrumental Methods of Analysis, Willard, H.H., Merrit, L.L., Dean, J.A., Settle P.A., Van Nostrand. 2. Principles of Instrumental Analysis, Skoog, D.A., Heller, F.J., Nieman, T.A., WB Saunders,2003 3. HPTLC: Quantitative Analysis of Pharmaceutical Formulations, Sethi, P.D., CBS Publishers, Delhi. 4. Gel electrophoresis of proteins: a practical approach, B. D Hames, Oxford university press 5. Shimadzu 2010 LC operational manual (http://www.ssi.shimadzu.com/products/literature/HPLC/C196-E056G.pdf) 6. Camag HPTLC operational manual (http://www.camag.com) 7. A practical handbook on Preparative HPLC, D Wellings, Elsevier 8. Thin layer chromatography: A modern practical approach. UK: The royal society of chemistry; Peter EW, 2005. 9. http://www.biopac.com © CHARUSAT 2012 Page 231 of 240 Elective II (PHARMACEUTICAL DOCUMENTATION-II) (PH414.02) Credits: 1.5 Contact Hours per week: 3 Objective of the Course: To make students familiar with different documentation practice followed in pharmaceutical industry. Student Learning Outcomes / Objectives: The students are expected to o Learn preparations of various documents involved in pharmaceutical industry having application in clinical research, regulatory affairs, and scientific writing. Detailed syllabus: List of Practicals: To study and understand components of clinical research protocols To prepare sample Preclinical study reports, expert reports, and summaries To prepare package inserts for o Any one dosage form (Example - Ophthalmic preparation – Eye Drop) o Medical Device (example Metered-Dose Inhaler) To prepare evidence based medicine reports in different clinical decision making queries using Literature and Internet resources (eg Probiotics in treatment of Irritable bowel Syndrome) To study sample dossier for getting approval of solid dosage form (national and/or international) To understand basics of writing scientific article and to write a review article in group of 4-5 on any selected topic and manuscript submission Instructional Methods and Pedagogy: Every week, a three hour slot to be allocated for the course. During this three hour slot, first hour may be allocated for theory while rest of two hours shall be allocated to practicals to be performed The faculty shall explain 1. Using black board, notes, government documents 2. By conducting practicals and projects © CHARUSAT 2012 Page 232 of 240 3. Using Over Head Projector, Multimedia projector. Evaluation Scheme & Guidelines: The evaluation shall comprise of total 100 marks, 80 marks university level evaluation and 20 marks institute level evaluation Institute will announce the schedule of examination in consultation with university (same as practical exams) Institute evaluation of 20 marks will comprise of journals, attendance, mid-term project report, presentations, practical performances, quizzes, case-analysis, viva, synopsis, and/or descriptive questions. University evaluation of 80 marks will comprise of projects, presentations, practical performances, quizzes, case-analysis, viva, synopsis, and/or descriptive questions. Recommended Books/Journals/Websites: 1. Pharmacoepidemiology, Brian L. Strom,Publisher: Wiley; 4 edition,2005 2. Essentials of Pharmacoeconomics, Karen Rascati, Publisher: Lippincott Williams & Wilkins; 1 edition,2008 3. http://www.ncbi.nlm.nih.gov/pubmed/ 4. Principles and Practice of Clinical Research by John I. Gallin, Frederick P. Ognibene 5. http://www.cebm.net/ 6. www.fda.gov © CHARUSAT 2012 Page 233 of 240 Elective II PHARMACEUTICAL MARKETING-II (PH414.03) Credits: 1.5 Contact Hours per week: 3 Objective of the Course: To make students familiar with marketing practices followed in pharmaceutical industry. Student Learning Outcomes / Objectives: The students are expected to o Learn the skills of marketing to promote the sale of drug products and pharmaceuticals. Detailed syllabus: Sr. Topic No 1 Pharmaceutical Marketing Channels & Logistics & Promotion Management Basics of distribution in Indian Pharmaceutical market Pharmaceutical Distribution Channels Designing and managing Marketing channels Managing retailers, Distributors, C&F logistics Designing and managing Integrated Marketing Communication for OTC and Rx based products 2 International Marketing Introduction to International Trade & Marketing Role of regional economic interaction Immerging markets and method of entry Pharmaceutical Import / Export Export documentation and Govt. policies Export Finance, Shipping and Packaging Instructional Methods and Pedagogy: Every week, a three hour slot to be allocated for the course. During this three hour slot, first hour may be allocated for theory while rest of two hours shall be allocated to practicals/projects to be performed © CHARUSAT 2012 Page 234 of 240 The practical comprises of preparing marketing plan for domestic/international sales, case-analysis, field work, presentations, etc. The faculty shall explain 1. Using black board, notes 2. By conducting practicals and projects 3. Using Over Head Projector, Multimedia projector. Evaluation Scheme & Guidelines: The evaluation shall comprise of total 100 marks, 80 marks university level evaluation and 20 marks institute level evaluation Institute will announce the schedule of examination in consultation with university (same as practical exams) Institute evaluation of 20 marks will comprise of journals, attendance, mid-term project report, presentations, practical performances, quizzes, case-analysis, viva, synopsis, and/or descriptive questions. University evaluation of 80 marks will comprise of projects, presentations, practical performances, quizzes, case-analysis, viva, synopsis, and/or descriptive questions. Recommended Books/Journals/Websites: 1. Marketing Strategies by Saxena Rajan, Tata-McGraw Hill, latest edition 2. The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (third edition) by Martin A. Voet 3. Pharmaceutical Marketing: Principles, Environment, and Practice by Eugene Mick Kolassa, James Greg Perkins, Bruce R Siecker 4. The Strategic Pricing of Pharmaceuticals by E.M. (Mick) Kolassa 5. Strategic Pharmaceutical Marketing: A Practical Guide by Sanjay Pajpai 6. Global Pharmaceuticals: Ethics, Markets, Practices by Adriana Petryna, Andrew Lakoff, Arthur Kleinman 7. Forecasting for the Pharmaceutical Industry: Models for New Product And In-market Forecasting And How to Use Them by Arthur G. Cook 8. Excel Sales Forecasting For Dummies(r) by Conrad Carlberg 9. Pharmaceutical Sales Revolution by Scott Moldenhauer (Author) 10. MSDR: Medical Sales Desk Reference: Increase Your Sales and Commissions then Fast Track your Career as a Modern Medical or Pharmaceutical Sales Executive by Ryan Gray © CHARUSAT 2012 Page 235 of 240 11. Merrill Goozner: The $800 million pill. University of California Press, Berkeley 2004 12. International Journal of Pharmaceutical and Healthcare Marketing 13. Journal of Medical Marketing 14. Journal of the Indian Medical association (JIMA). © CHARUSAT 2012 Page 236 of 240 ENTREPRENEURSHIP FOR PHARMA PROFESSIONALS (MB 402) (Theory, Practical and Project) Credit :6 3.0 (Theory) 1.5 (Practical) 1.5 (Project) Contact Hours per week: 9 3.0 (Theory) 3.0 (Practical) 3.0 (Project) Objective of the Course: The purpose of this course is to prepare a ground where the students view entrepreneurship as a desirable and feasible career option. In particular the course seeks to build the necessary competencies and motivation for a career in entrepreneurship. Student Learning Outcomes / Objectives: After studying this course, the students would be competent to build on personal as well as external resources with a view to effectively launch and later on manage their enterprise. They would have not only an idea as to which support/developmental agency to look up to and for what purpose, but also the necessary know-how for accessing their help. They would have basic skills in operations, finance, marketing and human resource management. Instructional Methods and Pedagogy: The faculty shall explain using black board, notes, manuals Using Over Head Projector, Multimedia projector. Field Work © CHARUSAT 2012 Page 237 of 240 Outline of the Course: (Theory) Minimum No. of No. Unit contact Approx. Weightage hours Entrepreneur-Entrepreneurship-Enterprise- 1. Intrapreneurship % 9 20 2. Opportunity scouting and idea generation 9 20 3. Entrepreneurial Challenges in small business 9 20 4. Governments Role in Growth of MSMEs & SMEs 6 13.3 5 Enterprise Scale Up, Growth & Harvesting 6 13.3 6 13.4 45 100 Case studies on successful and unsuccessful 6 entrepreneurs and ventures Total Detailed Syllabus (Theory): Minimum No. No. of Unit Contact Hours Entrepreneur-Entrepreneurship-Enterprise- Intrapreneurship: • Conceptual issues. • Entrepreneurship vs. Management. • Role of entrepreneurs in relation to the enterprise and in relation to the economy. 1. • Entrepreneurship as an interactive process between the individual 9 and the environment. 2. • Small business as the seedbed of entrepreneurship. • Entrepreneurial competencies. • Entrepreneurial motivation, performance and rewards. • Scope and Need of NGO’s in Pharmaceuticals Opportunity scouting and idea generation: • 9 Role of creativity & innovation and © CHARUSAT 2012 Page 238 of 240 business research. • Sources of business ideas. • Concept of Technopreneur – Technology based Enterprise (products protected by patent taken up for commercialization) • Entrepreneurial opportunities in contemporary business environment, for example opportunities in pharmaceuticals • The process of setting up a small business. • Business Plan- contents, importance, pre-requisites for an effective business plan. Entrepreneurial Challenges in small business • Sources of venture capital, fixed capital, working capital and a basic awareness of financial services such as 3. venture capital, private equity, leasing and factoring. • The concept and application of product life cycle, advertising & 9 publicity, sales & distribution management. • HR challenges- Availability of talent, retention, compensation, etc. • Legal and Government Challenges. Governments Role in Growth of MSMEs & SMEs Schemes from Central Governments, State Governments and Facilitating institutions in the sectors of 4. • Chemicals • Healthcare • Pharmaceuticals 6 Enterprise Scale Up, Growth & Harvesting A) Methods and Ways to take the small enterprise to large scale Organizations. B) Funding Options: 5 • Bank Loans/Other Private Funding • Listing on stock exchanges • Partnership & Alliances – Global Companies • Other Alternatives 6 C) Harvesting the correct potential of Enterprise. 6 Case studies on successful and unsuccessful entrepreneurs and ventures © CHARUSAT 2012 Page 239 of 240 6 Detailed Syllabus (Practical) and Evaluation Guidelines Practicals would be based on case-studies analysis. During the semester, 12-15 casestudies will be discussed and analyzed. All case-studies discussed during the semester have to be documented in report form. The internal evaluation would be based on the attendance, journal, case-analysis and viva voice The external Evaluation exam will comprise of analysis of case-study/case-studies and viva voice. Detailed Syllabus (Project) and Evaluation Guidelines: Business Plan The project will include preparation of a business plan. It will be a group project among 3-4 students. For every group of students, one faculty member may serve as a project guide. The internal evaluation will be conducted as a mid-term presentation, report submission and viva-voice of partial developed business plan. The external evaluation would be based on final business plan prepared, presentation and viva voice. Recommended Books/Journals/Website: 1. Brandt, Steven C., The 10 Commandments for Building a Growth Company, Third Edition, Macmillan Business Books, Delhi, 1977 2. Dollinger, Mare J., Entrepreneurship: Strategies and Resources, Illinois, Irwin, 1955. 3. Entrepreneurial Business Law Journal 4. Entrepreneurship Theory and Practice 5. Holt, David H., Entrepreneurship: New Venture Creation, Prentice-Hall of India, latest Edition. 6. http://msmestartupkit.com 7. http://www.dcmsme.gov.in 8. Journal of Business Venturing 9. Journal of Developmental Entrepreneurship 10. Journal of International Entrepreneurship 11. Journal of Small Business Management 12. Journal: Entrepreneurship and Regional Development. 13. Kazmi, Azhar, “What Young Entrepreneurs Think and Do: A Study of Second Generation Business Entrepreneurs,” The Journal of Entrepreneurship, 8, No. 1, 1999, pp. 67-78. 14. Small Business Economics 15. Vesper, KarlsH, New Venture Strategies, (Revised Edition), New Jersey, Prentice- Hall, 1990. © CHARUSAT 2012 Page 240 of 240
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