NORTH MAHARASHTRA UNIVERSITY, JALGAON STRUCTURE AND SYLLABUS FOR M. PHARM.

I. NOMENCLATURE: Ordinances regulating including scheme and syllabi relating to the degree of master of pharmacy ( M.Pharm.) Post graduate course (modified) with effect from academic year (2009-10) Course title: Master of Pharmacy Abbreviation: M.Pharm. North Maharashtra University Jalgaon offers Master of Pharmacy (M. Pharm.) course of two years (Four semesters) duration in the following specialization; 1) Pharmaceutical Chemistry 2) Pharmacognosy 3) Quality Assurance 4) Pharmacology 5) Pharmaceutics 6) Clinical Pharmacy (Pharmacy Practice) II. ELIGIBILITY: The eligibility for admission to the M Pharm. course is as under: The candidate who has passed the examination for the degree of B. Pharm. of University of North Maharashtra University, Jalgaon or any other statutory University, recognized as equivalent thereto by this university, with at least 60% of aggregate marks or equivalent grade (55% marks for S.C./S.T., teacher and sponsored candidates) will be eligible for admission to one of the specializations of pharmacy mentioned above. III. FEES: The Fees and deposits shall be as prescribed by the competent Authority appointed by Govt. of Maharashtra. IV. DURATION: The duration of Master of Pharmacy (M. Pharm.) Course is of 24 months, divided into four semesters, each semester of 6 months. V. GRANT OF TERMS: The candidate will be granted a term provided he/she has satisfactorily completed the prescribed course of study & has kept 75% attendance for theory & practical (wherever applicable) separately for each subject. Similarly the student will have to keep 75% attendance for guest Lectures, Seminars, Group Discussion, Journal Club activities etc. VI. SEMINAR: The student will have to appear for one seminar in each semester. The topic of M.Pharm. I & II sem. shall be selected from paper of specialization. The topic for M.Pharm III shall be selected from dissertation. The topic for M.Pharm. IV sem. shall be on entire work of dissertation.
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The grades will be awarded for the performance in each seminar as follows: O - 80% or above marks. A - 60% but less than 80% marks. B - 50% but less than 60% marks. C - Less than 50% marks. D - Less than 40% marks. The student will be considered to have passed in seminar provided he/she has obtained at least C grade. If a student fails to secure minimum C Grade in the seminar even at the second attempt, he/she will be required to give the seminar again in the next semester. The grade awarded to the student in the seminar will be shown separately in his statement of marks of the concerned semester. (Note: Bound volume of seminar record should be maintained and separate seminar grade sheet should be submitted to university within time schedule for each semester) VII. SCHEME OF EXAMINATION A. Internal examination (Sessional Examination): There shall be one internal examination in each subject conducted at the college level in M.Pharm I and M.Pharm-II semesters for both theory and practical after completion of at least two third of the semester instructional weeks. The sessional examination shall include both theory and practical (Scaling down technique will be applied for sessional examination marks). Internal Examination (Sessional Examination) Duration (Hours) Marks B. University Examination: There shall be a University examination at the end of M.Pharm I and II sem. and M.Pharm- III & IV sem. (combined), thesis evaluation). University Examination Duration (Hours) Marks Theory 03 80 Practical 06 80 Theory 01 20 Practical 06 20

C. Scheme for Theory Examination: Each university theory paper will consist of 80 marks. There will be total twelve questions; out of which the candidate will have to attempt eight questions. Each question will be of 10 marks. D. Dissertation: Every student after completion of M. Pharm.-IV sem. is required to submit five typewritten copies of the Dissertation duly certified by the Guide and Principal to the College ( Concern college will retain two copies for guide and library) and three will
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be submitted to the University for Evaluation. The dissertation is to be submitted not before 23 months from the date of commencement of first term of M. Pharm. Course. If candidate fails to submit his/her dissertation within 24 months, he/she will have to submit dissertation in subsequent semester. The Principal of the concerned College/Institute will forward the dissertation to the University Examination Section. There shall be not more than six submissions of dissertations in one academic year under each fulltime recognized PG guide by NMU. Fulltime recognized PG Teacher/Guide from other institute in same university jurisdiction shall submit not more than two dissertations in a one academic year. If the subject of dissertation entails collaboration with other departments or specialties, the collaborative portion of the work will be supervised by Co-Guide, designated by the Principal of the College/Institute in consultation with the Guide. Where a Co-Guide is involved, the dissertation will be certified jointly by the Guide & Co-guide. The Guide or any other Recognized Post-graduate teacher in the subject (Internal Examiner) and an External Examiner appointed by the University will examine the dissertation. The Examiners will jointly assign the marks for dissertation out of 300 (including viva-voce of 100 marks). The allotment of marks of the dissertation shall be as under. Dissertation Work a) Reference work b) Experimental work c) Scientific contents d) Presentation/ communication d) Results / Conclusion Total marks = 30 = 60 = 20 = 40 = 50 = 200 Viva voce a) Scientific contents b) Presentation / Communication c) Discussion d) Report Total marks = 20 = 20 = 20 = 40 = 100

E. Standard of Passing of Theory and Practical: There will be separate passing of theory and practical examinations for each subject. Students will have to qualify Internal (Sessional) and University Examination separately. The students will be declared to have pass M.Pharm I and II semester examinations if he has obtained at least 45 % marks in all theory and practical examinations independently. VIII. Award of Class: Class will be awarded to the student on the basis of aggregate marks obtained by him/her at M. Pharm. I Sem., II sem. III sem. and IV sem. Examination taken together. First Class with Distinction - 70 % and above marks First Class - 60% and above, but less than 70% marks Second Class 50 % and above, but less than 60 % marks

IX. A.T.K.T/BACKLOG: A candidate can proceed from M. Pharm. I sem. to M. Pharm.-II sem. irrespective of the number of subjects in which he/she has failed. A candidate is allowed to proceed from M. Pharm.- II Sem. to M. Pharm.-III Sem., irrespective of the number of subjects in which he/she has failed in I & II sem. A candidate is also allowed to continue his/her research work and submit the dissertation irrespective of the subjects he/she has failed in I & II sem., however overall result of the M. Pharm. examination will be considered as fail until he/she has passed the M. Pharm. I & II sem. Examinations.

M.PHARM. COURSE STRUCTURE SPECIALIZATION: PHARMACEUTICAL CHEMISTRY Branch Code : PC

Sem. Code Paper Scheme of Teaching Hrs/Weeks Scheme of Examination Theory/ Practical Total Marks

MT 100 MT-100P PC-101 I PC-101P

Modern Analytical Techniques (T) Modern Analytical Techniques (P) Advanced Pharmaceutical Chemistry I(T) Advanced Pharmaceutical Chemistry I( P) Elective I(T) Seminar Grade : O/A/B/C/D

03 06 03 06 03

Hr UE IE 03 01 06 03 06 03 06 01 06 01

Marks UE IE 80 20 80 80 80 80 20 20 20 20

100 100 100 100 100 500 100 100 100 100 100 500 --

MT-200 MT-300 II PC-201 PC-201P

Drug Regulatory Affairs and Intellectual Property Rights(T) Research Methodology and Biostatistics(T) Advanced Pharmaceutical Chemistry II (T) Advanced Pharmaceutical Chemistry II( P) Elective II (T) Seminar Grade: O/A/B/C/D Research Work

03 03 03 06 03

03 03 03 06 03

01 01 01 06 01

80 80 80 80 80

20 20 20 20 20

42

--

---

---

---

III Seminar on Research work Research work IV Grade: O/A/B/C/D 42 --------300 1300

Dissertation Defense , Viva/voce Seminar on Dissertation Grade :O/A/B/C/D Grand total

UE- University Examination ; IE Internal ( Sessional ) Examination Note: 1. 2. O/A/B/C/D indicates the grade secured by the student in the seminar; O- Excellent; A-very good; B- good; C- Average; D- Poor. Elective I and Elective II should be chosen from the specialization

M.PHARM. COURSE STRUCTURE SPECIALIZATION: PHARMACOGNOSY Branch code: CG

Sem. Code Paper Scheme of Teaching Hrs/Week s Scheme of Examination Theory/ Practical Total Marks

Hr MT 100 MT-100 P CG -101 I CG-101 P Modern Analytical Techniques (T) Modern Analytical Techniques (P) Advanced Pharmacognosy -I (T) Advanced Pharmacognosy -I (P) Elective I(T) Seminar Grade: MT-200 MT-300 II CG-201 CG-201 P Drug Regulatory Affairs and Intellectual Property Rights(T) Research Methodology and Biostatistics(T) Advanced Pharmacognosy II(T) Advanced Pharmacognosy -II ( P) Elective II (T) Seminar III Seminar on Research work Research work IV Dissertation Defense ,Viva/voce Seminar on dissertation Grand total Grade 42 Grade: 03 03 03 06 03 O/A/B/C/D 42 ---03 06 03 06 03 UE 03 06 03 06 03 IE 01 06 01 06 01

Marks UE IE 80 20 80 80 80 80 20 20 20 20

100 100 100 100 100 500 100 100 100 100 100 500 --

O/A/B/C/D 03 03 03 06 03 01 01 01 06 01 80 80 80 80 80 20 20 20 20 20

Research Work

---

-----

O/A/B/C/D --- --- ---

300 Grade :O/A/B/C/D 1300

UE- University Examination ; IE Internal ( Sessional ) Examination Note: 1. 2. O/A/B/C/D indicates the grade secured by the student in the seminar; O- Excellent; A-very good; B- good; C- Average; D- Poor. Elective I and Elective II should be chosen from the specialization

M.PHARM. COURSE STRUCTURE SPECIALIZATION: PHARMACEUTICS Branch code: PH

Sem. Code Paper Scheme of Teachin g Hrs/ Week Scheme of Examination Theory/ Practical Total Marks

Hr UE MT- 100 MT-100P PH-101 I PH-101P Modern Analytical Techniques (T) Modern Analytical Techniques (P) Advanced Pharmaceutics-I (T) Advanced Pharmaceutics-I ( P) Elective I(T) Seminar MT-200 MT-300 II PH-201 PH-201P Drug Regulatory Affairs and Intellectual Property Rights(T) Research Methodology and Biostatistics(T) Advanced Pharmaceutics II (T) Advanced Pharmaceutics -II ( P) Elective II (T) Seminar Grade: O/A/B/C/D Research Work III Seminar on Research work Research work IV Dissertation Defense Viva/voce Seminar on Dissertation Grade 42 42 ---03 06 03 06 03 03 06 03 06 03 IE 01 06 01 06 01

Marks UE IE 80 80 80 80 80 20 20 20 20 20 100 100 100 100 100 500 100 100 100 100 100 500 --

Grade :O/A/B/C/D 03 03 03 06 03 03 03 03 06 03 01 01 01 06 01 80 80 80 80 80 20 20 20 20 20

---

-----

O/A/B/C/D --- -----

300 Grade Grand total O/A/B/C/D 1300

UE- University Examination; IE Internal (Sessional) Examination Note: 1. 2. O/A/B/C/D indicates the grade secured by the student in the seminar; O- Excellent; A-very good; B- good; C- Average; D- Poor. Elective I and Elective II should be chosen from the specialization

PHARM. COURSE STRUCTURE SPECIALIZATION: QUALITY ASSURANCE Branch code: QA

Sem. Code Paper Scheme of Teaching Hrs/Weeks Scheme of Examination Theory/ Practical Hr UE IE 03 01 06 03 06 03 06 01 06 01 Marks UE 80 80 80 80 80 Total marks

MT- 100 MT-100P QA-101 I QA-101P

Modern Analytical Techniques (T) Modern Analytical Techniques (P) Quality Assurance I ( T) Quality Assurance I( P) Elective I(T) Seminar

03 06 03 06 03 Grade 03 03 03 06 03

IE 20 20 20 20 20

100 100 100 100 100 500 100 100 100 100 100 500 --

O/A/B/C/D 03 03 03 06 03 01 01 01 06 01 80 80 80 80 80 20 20 20 20 20

MT-200 MT-300 II QA-201 QA-201P

Drug Regulatory Affairs and Intellectual Property Rights(T) Research Methodology and Biostatistics(T) Quality Assurance - II (T) Quality Assurance II ( P) Elective II (T) Seminar Grade :O/A/B/C/D Research Work

42 Grade 42

--

---

---

-----

III Seminar on Research work Research work IV Dissertation Defense, Viva/voce Seminar on dissertation 300 Grade :O/A/B/C/D Grand total 1300 O/A/B/C/D --- -----

UE- University Examination ; IE Internal (Sessional ) Examination Note: 1. 2. O/A/B/C/D indicates the grade secured by the student in the seminar; O- Excellent; A-very good; B- good; C- Average; D- Poor. Elective I and Elective II should be chosen from the specialization

M.PHARM. COURSE STRUCTURE SPECIALIZATION: PHARMACOLOGY Branch Code: PL

Sem. Code Paper Scheme of Teachin g Hrs/We eks Scheme of Examination Theory/ Practical Total marks

Hr MT- 100 MT-100P PL-101 I PL-101P Modern Analytical Techniques (T) Modern Analytical Techniques (P) Advanced Pharmacology- I(T) Advanced Pharmacology-I( P) Elective I(T) Seminar MT-200 MT-300 II PL - 201 PL-201P PL - 202 Drug Regulatory Affairs and Intellectual Property Rights(T) Research Methodology and Biostatistics(T) Advanced Pharmacology -II (T) Advanced Pharmacology II( P) Elective II (T) Seminar Grade: O/A/B/C/D 03 06 03 06 03 Grade 03 03 03 06 03 UE 03 06 03 06 03 IE 01 06 01 06 01

Marks UE 80 80 80 80 80

IE 20 20 20 20 20

100 100 100 100 100 500 100 100 100 100 100 500

O/A/B/C/D 03 03 03 06 03 01 01 01 06 01 80 80 80 80 80 20 20 20 20 20

Research Work III Seminar on Research work Research Work IV Dissertation, Defense,Viva/voce Seminar on dissertation

42 Grade 42

--

---

---

------300 1300

O/A/B/C/D ---------

----Grade : O/A/B/C/D Grand total

UE- University Examination ; IE Internal ( Sessional ) Examination Note: 1. 2. O/A/B/C/D indicates the grade secured by the student in the seminar; O- Excellent; A-very good; B- good; C- Average; D- Poor. Elective I and Elective II should be chosen from the specialization

Sem .

Code

M.PHARM. COURSE STRUCTURE SPECIALIZATION: CLINICAL PHARMACY Branch code: CP Paper Scheme Scheme of Examination of Teaching Theory/ Practical Hrs/Week s Hr UE IE 01 06 01 06 01 Marks U IE E 80 20 80 80 80 80 20 20 20 20

Total Marks

MT- 100 MT-100 P I CP-101 CP-101P

Modern Analytical Techniques (T) Modern Analytical Techniques (P) Pharmacotherapeutics & Clinical Pharmacy-I(T) Pharmacotherapeutics & Clinical Pharmacy-I( P) Elective I(T) Seminar Grade: O/A/B/C/D

03 06 03 06 03

03 06 03 06 03

100 100 100 100 100 500 100 100 100 100 100 500 --

MT200 MT300 II CP-201 CP-201 P

Drug Regulatory Affairs and Intellectual Property Rights Research Methodology and Biostatistics(T) Pharmacotherapeutics & Clinical Pharmacy-II(T) Pharmacotherapeutics & Clinical Pharmacy-II(P) Elective II (T) Seminar Grade : Research Work

03 03 03 06

03 03 03 06

01 01 01 06 01

80 80 80 80 80

20 20 20 20 20

03 03 O/A/B/C/D 42 --

---

---

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III IV Seminar on Research work Grade O/A/B/C/D Research work 42 ----- --Dissertation Defense,Viva/voce Seminar on dissertation Grade O/A/B/C/D Grand total UE- University Examination; IE Internal (Sessional) Examination O/A/B/C/D indicates the grade secured by the student in the seminar; O- Excellent; A-very good; B- good; C- Average; D- Poor.
10

300 1300

Note: 1.

2.

Elective I and Elective II should be chosen from the specialization

Compulsory Papers for All M.Pharm. Branches : 1. In the M.Pharm I Semester: All M.Pharm students of all M.Pharm. branches will have compulsory papers; 1. MT-100 Modern Analytical Techniques (Theory) 2. 2. MT-100 P Modern Analytical Techniques (Practical).

In M.Pharm II semester All M.Pharm students of all M.Pharm. branches will have compulsory papers; 1. 2. MT-200 Drug Regulatory Affairs and Intellectual Property Rights (Theory) MT-300 Research Methodology and Biostatistics( Theory).

3.

The syllabus for compulsory subjects;

M.Pharm I semester MT-100- Modern Analytical Techniques (Theory) Aim and Objectives: The course is designed to provide knowledge to the students about the sophisticated instruments used for the analysis of pharmaceuticals and interpretation of chemical compounds. Upon completion of course, the student should be able to Know theory, principle, instrumentation and applications of the various sophisticated instrument such HPLC, GC, HPTLC, IR, NMR and Mass spectroscopy.. Development of the analytical methods. Duration: 3 Hrs/ week Total Hours: 45 Sr No Topics Section I 1 a b c 2 a Introduction Introduction to Pharmaceutical Analysis and techniques, method development, bioanalytical method development and validation of methods. Impurity profile of drugs Calibration and qualification of equipment Chromatography Chromatography: General Principles, classification of chromatographic 02 02 01 02 Hrs

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techniques, normal and reversed phase, bonded phase, Separation mechanism. b Column chromatography: Theory, instrumentation Merits and Demerits, Short column chromatography and flash chromatography, vacuum liquid chromatography (VLC), medium pressure liquid chromatography(MPLC), High performance liquid chromatography(HPLC), Ultra pressure liquid chromatography(UPLC), supercritical fluid chromatography(SCF),. TLC, HPTLC, overpressure layer chromatography (OPLC), Centrifugal chromatography: Instrumentation principle and applications Counter current chromatography, droplet counter current chromatography, ion exchange chromatography, affinity, size exclusion and ion pair chromatography Gas chromatography, principle, theory, instrumentation and applications. Number of lecture Section II 3 a Spectral Analysis Ultraviolet and visible spectroscopy: Energy levels and selection rules, Woodward Fischer rule, Fischer Kuhn and Nelson rules. Influence of substituents, ring size and strain on spectral characteristics; solvent effects; steriochemical effects; non conjugated interactions; spectral correlation with structure. Instrumentation and pharmaceutical applications UV spectrophotometry. Infra-red spectroscopy (IR): Theory and instrumentation of IR spectroscopy. Characteristics regions of spectrum, influence of substituents, link size, hydrogen bonding, vibrational coupling and field effect on frequency. Determination of stereochemistry. Spectral interpretation with examples. Nuclear Magnetic Resonance Spectrometry (NMR): Theory and instrumentation of NMR (H and C). Magnetic nuclei, chemical shifts and shielding and relaxation process, chemical and magnetic non equivalence, local diamagnetic shielding and magnetic anisotropy, spin spin splitting, Pascals triangle, coupling constant, mechanism of coupling quadrapole broadening and decoupling, effect of confirmations and stereochemistry on the spectrum, disteriomeric protons virtual coupling, long range coupling epi , peri, bay effects. Shifts reagent mechanism of action, spin de coupling, double resonance. FT-NMR . Interpretation of C-NMR spectra. Interpretation of PMR spectra of some common drugs, study of high orders of splitting in PMR spectra. d Mass Spectrometry: Theory and instrumentation. Molecular ion and metastable peak , fragmentation pattern, nitrogen and ring rules, Mclafferty rearrangement, electron and chemical ionization modes, applications. Interpretation of mass spectra of some important drugs. Determination of 03 03 03 22 07

c d

05

03

04

12

molecular weight. High resolution MS. e 4 a Spectroscopic Problems : Problem based on UV-spectroscopy , NMR , Mass and IR spectroscopy Other Analytical techniques Thermal Analysis : Theory, instrumentation and applications of thermo gravimetric analysis, differential thermal analysis, differential scanning calorimetry Immunochemical techniques: Immunoelectrophoresis, immunoprecipitation, ELISA , radioimmunoassays Electrophoresis : capillary electrophoresis Hyphenated techniques : GC-MS, LC-MS, MS-MS pharmaceutical applications Number of Lectures Total lectures Recommended Books [1] Skoog: Principles of Instrumental Analysis (Saunders College Publishing Philadelphia) [2] M. Orchin and H. H. Jaffe Theory and applications of ultra violet spectroscopy (John Wiley and Sons, N. Y.) [3] Silverstein, Basserler, Moriil Spectrometric identification of organic compounds. (John Wiley and Sons, N. Y.) [4] Willard, Merritt, Dean Instrumental Methods of Analysis (CBS Publishers and Distributors, Delhi) [5] J. R. Dyer Applications of Absorption Spectroscopy of Organic compounds (Prentice Hall, London) [6] C. N. R. Rao-Chemical Application of Infra-red spectroscopy(Academic press, N.Y.) [7] Higuchi: Instrumental Methods of Analysis (CBS Publishers) [8] Analytical Chemistry by open learning series [9] R. J. Hamilton Introduction to High Performance Liquid chromatography, (Chapman and Hall, London). [10] Ewing-Instrumental Methods of Chemical Analysis (McGraw Hill Book Co.N.Y.) [11] L.M. Jackmann and B.D. Sternhell Application of NMR spectroscopy in Organic chemistry (Pergamon Press, London.). [12] J.W.Munson- Pharmaceutical Analysis- Modern methods Part A and Part B (Marcel Dekker). 02 23 45 02 04

b c d

02

13

MT-100 P- Modern Analytical Techniques (Practical) Duration 6 Hrs/ week Sr. no. 1. 2. 3. 4. 5 7 8 9 10 11 12 13 15 Name of Experiment UV-Vis spectroscopy Calibration of Spectrophotometer Determination of drug in bulk and Pharmaceutical formulation using UV- spectrophotometry Simultaneous quantification of two/ three drugs by UVspectrophotometry Colorimetric estimation of drug in bulk and pharmaceutical formulations Validation of analytical method IR-Spectroscopy To perform the IR of given sample and interpret the spectrum High Performance Liquid Chromatography Calibration of High performance liquid chromatograph Estimation of drugs in bulk and pharmaceutical formulations using HPLC Validation of HPLC method Gas Chromatography Quantitative estimation of drugs in pharmaceutical formulations HPTLC Demonstration of HPTLC Quantitative estimation of drug from pharmaceutical formulation using HPTLC Experiments using Flame photometer, atomic absorption spectrophotometer , spectrofluorometer. No. of experiment 01 02 03 01 02 04 01 02 01 01 01 01 02

Note: Minimum 12 experiments are compulsory Recommended Books / Journals [1] Willard, Merritt, Dean Instrumental Methods of Analysis (CBS Publishers ) [2] Higuchi: Instrumental Methods of Analysis (CBS Publishers [3] Indian Pharmacopoeia 2007 [4] British Pharmacopoeia 2005 [5] Ewing Instrumental Methods of Chemical Analysis (McGraw Hill Book Co.New York) [6] Journals : Journal of planar chromatography; Acta chromatographica; Indian Drugs; Indian Journal of Pharmaceutical Sciences

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M.Pharm II semester MT-200 Drug Regulatory Affairs and Intellectual Property Rights (Theory) Duration: 3 Hrs/week Total Hours: 45

Aim and Objectives: The course is designed to provide detail knowledge about approaches involved in the functioning of drug regulatory affairs and Intellectual property rights. Upon completion of course, the student should be able to know 1. Pharmaceutical Administration and Management, Handling laboratory and manufacturing deviations, Impact of Total Quality performance, GMP Certification and enforcement actions, Compliance of Documentation, Regulatory agencies, and various guidelines. 2. Pollution and Environment control act requirements. 3. Intellectual Property Rights and its types along with emphasis on patents including- Basis of Patentability, Patent Application Procedure, Infringement, commercial aspects etc. Section-I Sr.No. Topic Hours 3 1 Drug Regulatory Affairs: Historical perspectives, organization structure, activities and responsibilities of Drug Regulatory Agencies in India, US, EU, Japan. 2 Standard Institutes and Certification Agencies like ISI, BSS, ASTM, 2 SOP, WHO, USFDA, UK, MCA, TGA, MCC 3 Abbreviated New Drug Application ( ANDA) and Investigational 7 New Drug Application (INDA) 4 Pollution and Environment control act. 3 9 5 International Conference on Harmonization, Good Clinical Practice Guideline, Good Laboratory Practice Guidelines, Good Manufacturing Practices Guidelines. 24 Number of Lectures Section-II 4 6 Intellectual Property Rights: - Introduction, Scope and objectives and IPR in Pharmacy. Basic terms and concepts of law (Indian Legal System) judicial structure and common law principles. 5 7 Concept of property with respect to intellectual creativity. Tangible and Intangible property. Concept of IPR, Scope and nature of patents, copyrights, trade mark, geographical limitations. 8 Concepts related to patents: - Novelty, Non-obviousness, Utility, 3 Anticipation, and Prior art etc., Types of Patents. 9 Global Perspective of patent system, role of international organization 2 WTO, WIPO, EPO in patent act. 10 Indian patent act 1970 and amendment, Copy right. 3 11 Patentability, Patent Application, Revocation of Patent, Infringement 4 and Litigation, Commercialization and Licensing. 21 Number of Lectures
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Total number of Lectures

45

Recommended Books [1] Willing S.H. Good Manufacturing Practices for Pharmaceuticals, Marcel Dekker, Inc. New York [2] Drug and Cosmetics Acts and Rules [3] Bharati, Drugs and Pharmacy laws in India [4] Syed Imtiaz Haider Pharmaceutical Master Validation Plan ( The Ultimate Guide to FDA , GMP and GLP compliance ; St. Lucie Press London). [5] Manohar Potdar , Pharmaceutical Quality Assurance Nirali Prakashan [6] P.A. Carson and N. Dent Good Clinical Laboratory and Manufacturing practices Techniques for the QA professional RSC Publishing. [7] Patel, A.H Industrial Microbiology Mc Millan Indian Ltd. Delhi [8] Nash R.A. and Wachter, A.H. Pharmaceutical Process Validation Marcel Dekker Inc, New York

MT-300 - Research Methodology and Biostatistics ( Theory) Duration: 3 Hrs/week Aim and Objectives: The course objectives are clear to learn various methodologies in research with emphasis on participants in drafting a scientific thesis writing in pharmacy fields and also to use basic concepts of statistics in determining the validity of research work Sr.no 1 Section I Topic Research: Meaning, Purpose, Types, (Educational, Clinical, Experimental, Historical Descriptive, Basic Applied And Patent Oriented Research) Objective and Need of Research Literature survey Use of Library, books & journals-Medlines-Internet, gating Patients & reprints of articles as a source for Literature survey. Defining the research Problem Identification, selecting a problem & preparing research proposals for Different of Research mention above. Process of research including Research design and elements of research Design Methods & tools use in research Qualities studies, quantitative studies simple data organization descriptive data analysis, Limitation & sources of Error Inquiries in form of Questionnaire, Opinionnare or by Interview Case study Documentation- Introduction, Techniques of documentation Importance of documentation, Uses of Computer packages in documentation. Hrs 3 Total Hours: 45

2 3 4 5

2 3 1 3

16

9 10 11 12

The Research Report/ Paper writing/ thesis writing Different parts of the Research paper A. Title Title of project with authors name B. Abstract- Statement of the problem, Background list in brief and 1. Purpose and Scope; 2. Key Words. 3. Methodology-subject, apparatus, instrumentation & procedure. 4. Results- tables, graphs, figures & statistical presentation 5. Discussion support or non support of hypothesis, practical & 6. theoretical Implications 7. Conclusion 8. Acknowledgements. 9. References 10. Errata 11. Importance of Spell check for entire project 12. Uses of footnotes Presentation (Specially for oral) Importance, types different skills, contained, format of model, introduction & ending, Poster, Gestures, eye contact, facial, expressions, stage, fright, volumepitch, speed, Pause & language, Visual aids & seating, Questionnaire Cost analysis of the project: cost incurred on raw materials, Procedure, instrumentations & clinical trials. Sources for procurement of research grants Industry-Institute: Industrial projects, their feasibility reports. Section II( Biostatistics ) Bio-statistics Basic concepts of statistics: data, data graphic, frequency distribution, measures of central tendency (mean median, mode, harmonic mean, geometric mean and scattering of data (range, mean, deviation, standard deviation(SD) and Standard Error of Mean (SEM )etc. Introduction to Probabilities (Chance) Binominal and normal probabilities distribution. Sample and Sampling Method: Sample size, sample bias, sampling techniques, Simple random sampling, systematic, multistage, cluster, multiphase sampling, significance of sampling techniques and their application in pharmacy. Sampling variability and Significance: Sample distribution, Significance, estimation of population parameter, testing statistical hypothesis, Type-I and type-II errors, Tests of significance, Z-test, one-tailed and two tailed tests. Significance of difference in means: SEM, Applications and uses. Standard error of difference between two means of large samples, small samples, t-test, unpaired, paired, variance ratio test, Analysis of Variance (ANOVA) Significance of difference in proportions in large samples Standard error of proportion (SEP), applications and uses, standard error of difference between two proportions, SE (p1-p2) Hypothesis testing, chi-square test Correlation Analysis :Karl Pearsons correlation coefficient, Spearmans rank correlation coefficient
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2 1 1 2

13 14

2 3

15

16 17 18 19

6 2 1 1

Linear Regression Analysis: Application in Beers Lamberts curve, Stability study). Recommended Books: Research In Education- John V. Best, John V. Kahn 7th edition Presentation skills - Michael Hallon- Indian Society for Institute education Advanced research methodology by Prakash Srivastav, Prentice Hall 1984 Practical Introduction o copyright.- Gavin Mcfarlane Thesis projects in Science & Engineering Richard M. Davis. Scientist in legal Systems- Ann labor science Thesis & Assignment Jonathan Anderson Writing a technical paper- Donald Menzel Protection of industrial Property rights- P. Das & Gokul Das Documentation Genesis & Development 3792. Manual for evaluation of industrial projects-United Nations Manual for the preparation of industrial feasibility studies Manuals provided with the license version of the softwares (eg. Graph pad prism) [14] B. K. Mahajan. Methods in Biostatistics (for Medical students and Research worker), 6th Ed, 1997, Jaypee Brothers Medical publishers (P) Ltd., New Delhi. [15] S. BOLTON-pharmaceutical statistics [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13]

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M.PHARMACY

PHARMACEUTICAL CHEMISTRY
Branch Code : PC

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M.PHARMACY PHARMACEUTICAL CHEMISTRY Branch code : PC Semester I MT-100 : Modern Analytical Techniques ( Theory) : Refer page no. 11-18 MT-100P- Modern Analytical Techniques (Practical): Refer page no. 11-18 PC-101 Advanced Pharmaceutical Chemistry I (Theory) Aim and Objectives:The course is designed to provide detail information about advances in Organic chemistry and its application in Medicinal Chemistry. Upon completion of course, the student should be able to Know the principle and applications of stereochemistry & chiral drugs synthesis Novel concept of Green Chemistry & Solid phase Chemistry. Study the techniques of synthesis of Organic compounds. Section I Sr. No. Topic Hrs. 12 Stereochemistry and Chiral techniques: 1. a) Principles of stereochemistry including geometric, optical, and conformational isomerism, dynamic stereochemistry. b) Concept of Chiral drugs, Techniques of preparing Chiral drugs: , resolution of racemic mixture, racemic switches, asymmetric synthesis of: Vitamin C, Propranolol, Nifedepine, Atenolol, Ethambutol, Penicillamine, Omeprazole, Aspartame, Ampicillin, Thalidomide. c) Role of stereochemistry in pharmacokinetics and pharmacodynamics. 05 3. Catalysis. Introduction, PTC in anhydride, esters, epoxide, nitryl, sulphide formation, ester hydrolysis, and reduction reaction. 05 Green Chemistry. 4. Water as solvent, ionic liquids, supercritical liquids, supported reagents and catalyst, solvent free reactions activated by microwave and Ultrasound. 22 Number of lectures Section-II 09 5. Mechanism, Stereochemistry and applications of following reactions: Birch reduction, Micheal reaction, Meerwin Pondorffs V. reduction, Oppeaneur oxidation, Beckmanns rearrangement, Grignards reaction,
20

Hoffmans rearrangement, Ozonolysis, Reformatsky reaction. 07 Synthon approach: Terms used in synthon approach , Rules for 6. Disconnection approach, Synthons for C C bond formation, Difunctional compounds, Selective functional group interconversion, Retrosynthetic analysis. Synthesis of Rosiglitazone, Trimethorprim, Terfenadine, Ibuprofen, Fentanyl, Midalzolam, Ciprofloxacin, Captopril, Diclofenac, Lossartan. 03 7. Pericyclic reactions. Mechanism and types of Pericyclic reactions: Cycloaddition, electrocyclic and sigmatropic reactions 04 8. Solid phase chemistry. Reaction involved with mechanism which include protection, deprotection and coupling. 23 Number of lectures Total number of lectures 45 Recommended Books [1] Sykes- A Guidebook to Mechanism in Organic Chemistry. [2] March- Advanced Organic Chemistry Reaction Mechanisms. [3] Eliel- Stereochemistry of Carbon Compounds. [4] Surrey- Reaction in Organic Chemistry. [5] Hendrickson Organic Chemistry. [6] Jerry March- Advanced Organic Chemistry. [7] Asymmetric Synthesis, Vol. 1-7, Ed. J. A. Morrison [8] Chirotechnology - R.A Sheldon. [9] Norman, Principles of Organic Chemistry, Carry & Sunberg, Organic Chemistry Part A & B. [10] Stuart Warren: Organic Synthesis The Disconnection Approach (John Wiley & Sons)

PC-101P - Advanced Pharmaceutical chemistry I (Practical) Duration: 6 Hrs/Week

Sr. No. Name of Experiment No. of Experiments

1. 2

Separation and identification of given unknown organic binary mixture. To determine the partition coefficient/ PKa of organic compounds /drugs To carry out the synthesis and interpretation of the followings : Benzimidazole 7-hydroxy 4-methyl coumarin Phenylurea and diphenylurea Acetophenone Basic Operation of various techniques like Column chromatography, Preparative TLC, Molecular distillation, Fractional crystallization. Study and applications of Enzyme Kinetics, Inhibition.
21

5-6 04 4-5

3.

4 5

04 01

Note: Minimum 12 experiments should be conducted. Recommended Books [1] Organic Synthesis: Fieser and William Son (CBS Publisher) [2] Mann and Saunders, practical Organic Chemistry (Orient Longman) [3] AI Vogel, Practical Qualitative and Quantitative Organic Chemistry (Orient Longman) [4] Systemic Identification of Organic compounds by Shriner. [5] Introduction to organic laboratory techniques A microscale approach by Vavia. [6] Advanced Practical Organic Chemistry by N.K. Vishnoi. Semester II MT-200 Drug Regulatory Affairs and Intellectual Property Rights ( Theory) : Refer page no. 11-18 MT-300 Research Methodology and Biostatistics( Theory): Refer page no. 11-18 PC-201 Advanced Pharmaceutical Chemistry -II (Theory) Aim and Objectives:The course is designed to provide detail knowledge about advances in medicinal chemistry at molecular level and recent advances in medicinal chemistry. Upon completion of course, the student should be able to know The approach of combinatorial chemistry and other aspects of Drug designing. Use of Peptides in drug discovery. Study the Microbial biotransformation in synthesis of the drug molecule. Study the Recombinant DNA technology. Sr. No. 1. Section -I Topic Combinatorial chemistry Introduction, Combinatorial approaches, Chemical peptides and small molecule libraries, applications, methodology, combinatorial organic synthesis, Assay and screening of combinatorial libraries, Introduction to High Throughputs Screening (HTS). Introduction of Peptides in Drug discovery. Reactivity of proteins and peptides, Number of lectures Section-II 3. 4. Microbial transformation technology in the preparation of drugs. Theoretical and practical aspects. Recombinant DNA technology Protein engineering and site directed mutagenesis; genetically engineered drug discovery tools, reagents for screening, reagents for structural biology studies; enzymes as drug targets, receptors as drug targets, cellular adhesion proteins. Number of lectures
22

Hrs. 12

2.

10 22

10 13

23

Total number of lectures Recommended Books : [1] [2] [3] [4]

45

Ariens-Drug Design, Vol. VII. Smith-William-Introduction to the Principle of Drug Design. Woodridge-Progress in Pharmaceutical Research. Introduction to the Principles of Drug Design by John Smith & Hywel Williams (Wright PSG). [5] Guide to Chemical Basis of Drug Design by Alfred Burger (John Wiley & Sons) [6] Burgers Medicinal chemistry-The Basis of Medicinal chemistry by Manfred E. Wolff part-I (John Wiley & Sons). [7] Comprehensive Medicinal Chemistry by Hansch & Leo.

PC-201 P Advanced Pharmaceutical Chemistry -II (Practical)

Sr. no. Name of Experiment No of Experiment

To separate & identify the given unknown organic ternary mixture. Microwave assisted synthesis of heterocyclic compounds Application of Partition Coefficient, pKa, steric factors, electronic factors in QSAR studies with example by using software. Use of statistical regression analysis. 4. Resolution of Racemic Mixture. 5 To carry out the synthesis of compounds using 3 - 4 steps and their confirmation by TLC and spectral studies. * Minimum of 12 experiments should be conducted. Recommended Books [1] Organic Synthesis: Fieser and William Son (CBS Publisher) [2] Mann and Saunders, practical Organic Chemistry (Orient Longman) [3] A I Vogel, Practical Organic Chemistry (Orient Longman) [4] Systemic Identification of Organic compounds by Shriner. [5] Introduction to organic laboratory techniques A microscale approach by Vavia. [6] Advanced Practical Organic Chemistry by N.K. Vishnoi. [7] Microwave assisted synthesis of Organic compounds by V. K. Ahluwalia.

1. 2. 3.

04 04 04 01 04

23

M. PHARMACY

PHARMACOGNOSY
Branch Code : CG

24

M. PHARMACY PHARMACOGNOSY Branch Code : CG Semester I MT-100- Modern Analytical Techniques (Theory): Refer page no. 11-18 MT-100P - Modern Analytical Techniques (Practical): Refer page no. 11-18 CG -101 Advanced Pharmacognosy-I( Theory) Duration: 3 Hrs/week Total Hours: 45 Section-I Sr. No Topics Hrs
1. Extraction and separation technology 13

2.

I. General methods of extraction of primary and secondary chemicals of plant origin: maceration, percolation, heat-assisted extraction including micro-wave method, counter-current flow methods, supercritical fluid extraction. II. Chromatographic separation techniques: Chromatographic techniques used in qualitative and quantitative study of phytochemicals. TLC, column chromatography, Flash chromatography, HPLC, and solid phase extraction. Their principles, operation, and application to the plant derived products. III. Non-chromatographic separation techniques: Chemical derivatisation-based separation methods, fractional crystallization, centrifugation, Froth-floatation technique. IV. Extraction, isolation and purification of atropine, camptothecin, quarcetin, oleanolic acid and saponins of gymnemic acid. Spectral characterization of plant secondary products I. Overview of various methods used in characterization including UV, IR, Proton NMR, C NMR, Mass spectroscopy and crystallographic characterization. II. Spectral characterization of taxol, pinocembrin, curcumin and digoxin. III. Use of hyphenated tools in characterization of phytochemicals: LC-MS, MS-MS and GC-MS Number of lectures Section -II Ethnomedicinal uses of plants I. Definition of ethnobotany and ethnopharmacology, history and demographics of medicinal plants used in traditional human societies.
25
13

03

05

02 03
10

05

03 02 23
12

3.

02

II. Comparative study of system of professional and non02 professional traditional medicine. III. System of Indian traditional medicine, theories of disease 02 causation and aspects of ethnic medicinal literature. IV. Plant based drugs utilized in modern medicine that originated 04 from Indian traditional system. V. Ethnomedicinal study of some important medicinal plants from 02 Khandesh region. 10 4. Plant polysaccharides: Source, extraction, isolation and their applications as pharmaceutical excipients; Cellulose, Inullin, Starch, Pectin, Glucomannon 22 Number of lectures 45 Total number of lectures Recommended Books [1] Corrado Tringali, Bioactive Compounds from Natural Sources: Isolation, Characterization and Biological Properties. CRC Press, 2000. [2] Edward Joseph Shellard, Practical Plant Chemistry for Pharmacy Students. Pitman Medical. [3] Ghillean T. Prance, Derek Chadwick, Joan Marsh, Ethnobotany and the Search for New Drugs: Symposium. J. Wiley, 1994. [4] Gunnar Samuelsson, Drugs of Natural Origin: A Textbook of Pharmacognosy. Apotekarsocieteten, 1999. [5] Jean Bruneton, Caroline K. Hatton, Pharmacognosy, phytochemistry, medicinal plants. Lavoisier, 1999. [6] Jeffrey B. Harborne. Phytochemical Methods: A Guide to Modern Techniques of Plant Analysis. Springer, 1998. [7] John R. Williams and Tony Clifford, Supercritical Fluid Methods and Protocols: Methods and Protocols. Humana Press, 2000. [8] Joseph Sherma, Bernard Fried, Handbook of Thin-layer Chromatography, CRC. [9] Khandelwal K. R., Practical Pharmacognosy, Pragati Books Pvt. Ltd. [10] Kokate C. K., Gokhale SB and Purohit AP, Pharmacognosy., Nirali Prakashan. [11] Thomas Edward Wallis, Textbook of Pharmacognosy. Little, Brown, Boston], 1960. [12] Varro E. Tyler, Arthur Ernest Schwarting, Experimental Pharmacognosy. Burgess Pub. Co., 1962. [13] William Charles Evans, George Edward Trease, Daphne Evans. Trease and Evans Pharmacognosy. W.B. Saunders, 2002. Original from the University of Michigan Digitized Aug 20, 2008. Recommended Journals Biological and Pharmaceutical Bulletin Indian Drugs Indian Journal of Pharmacology Journal of Agriculture and Food Chemistry Journal of Chromatography Journal of Ethnopharmacology Natural Product Reporter Phytochemistry Phytomedicine Phytotherapy Research Planta Medica
26

CG -101P- Advanced Pharmacognosy-I (Practical) Duration: 6 Hrs/ week Total Hours: 45 Sr. No Name of experiment Number of experiments 1. Microscopic study of crude drugs and preparation of permanent 03 slides (double staining technique) 2. Study of different techniques of extraction (cold maceration, 03 soxhlet extraction, and micro-wave extraction) 3. Extraction and isolation of mucilage and pectin 03 4. Extraction of alkaloids and saponins. 03 5. Extraction and estimation of total phenolics, flavonoids, 04 proanthocyanidines, and eugenol Demonstrations 6. Working and applications of Flash Chromatography 01 01 7. Use of statistical softwares for optimization of extraction methods and determination of level of statistical significance in animal experimentation. 8. Working and applications of Spray Dryer 01 Note: Minimum 12 experiments should be conducted. Recommended Books
[1] Kokate C. K., Practical Pharmacognosy, Vallabh Prakashan, 1993.

[2] Leland J. Cseke, Ara Kirakosyan, Peter B. Kaufman, Sara Warber, James A. Duke. Natural Products from Plants. CRC Press, 2006. [3] Mamata Mukhopadhyay, Natural Extracts Using Supercritical Carbon Dioxide, CRC Press, 2000. [4] Nadkarni A. K. Indian Materia Medica: With Ayurvedic, Unani-tibbi, Siddha, Allopathic, Homeopathic, Naturopathic and Home Remedies. Popular Book Depot. [5] Nikolaus H. Fischer, Murray B. Isman, Modern phytochemical methods. Plenum Press. [6] Norman Grainger Bisset, Max Wichtl. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis. Medpharm Scientific Publishers, 1994. [7] Pulok K. Mukherjee. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals. Business Horizons, 2002.Original from the Univ. of Michigan Digitized. [8] Raaman, N., Phytochemical Techniques. New India Publishing. [9] Rangari Vinod. D., Text book of Pharmacognosy and Phytochemistry Vol. I and II, Carrier Pub., 2006. [10] Richard J. P. Cannell. Natural Products Isolation. Humana Press, 1998. [11] Richard P. Steiner, Folk Medicine: The Art and the Science. ACS, 1986. [12] Robert H. Marchessault, Polysaccharides for Drug Delivery and Pharmaceutical Applications (ACS Symposium). Oxford University Press. Annotation, 2006. [13] Satyajit D. Sarker, Zahid Latif, Alexander I. Gray. Natural Products Isolation. Springer, 2005. [14] Severian Dumitriu, Polysaccharides: Structural Diversity and Functional Versatility. CRC Press, 2004. ISBN 0824754808, 9780824754808. [15] Stephen J. Cutler, Horace G. Cutler. Biologically Active Natural Products: Pharmaceuticals. CRC Press, 1999. [16] Steven M. Colegate, Russell J. Molyneux. Bioactive Natural Products: Detection,
27

Isolation, and Structural Determination. CRC Press, 2007. [17] Teresa Kowalska, Joseph Sherma, Preparative Layer Chromatography. CRC [18] Thomas Edward Wallis, Analytical Microscopy: Its Aims and Methods in Relation to Foods, Water, Spices and Drugs. Little, Brown, 1966. [19] Thomas Edward Wallis, Practical Pharmacognosy. Churchill, 1948. Semester II MT-200 Drug Regulatory Affairs and Intellectual Property Rights(Theory): Refer page no. 11-18 MT-300 Research Methodology and Biostatistics (Theory): Refer page no. 11-18 CG-201 Advanced Pharmacognosy-II ( Theory) Duration: 3 Hrs/ week Sr. No Total Hours: 45 Hrs 18 02 02 03

1.

2.

3.

4.

Section -I Topics Drug discovery from plant sources I. History and strategies of drug discovery II. General consideration of chemical diversity, molecular design, molecular chirality, 3D-comlpexiety of phytochemicals. III. Chemical ecology and drug discovery: brief study of the role of signaling molecules and of the chemicals deployed for defense against predators, pathogens and parasites and how this information is useful in discovering the prototype compounds. III. Drug discovery from terrestrial plants IV.Ethnomedicine and drug discovery. V. Plant metabonomics: Principles and applications in the drug discovery, metabolite profiling of some herbal drugs by high resolution LC-MS Marine drugs I. Anti-cancer, anti-infective, anti-inflammatory and drug acting on cardiovascular system II. Potential of Indian oceans as a source of drugs Number of lecture Section -II Biological diversity I. Chemical diversity versus functional diversity, terrestrial plant chemical diversity versus marine chemical diversity II. Role of biodiversity in drug discovery, environmental protection and national economy III. Biodiversity conservation: Methods aimed at preservation of medicinal plants biodiversity Plant polysaccharides: Source, extraction and isolation and their applications as pharmaceutical excipients
Dextran, Gellan gum, Galactomannan (Gaur gum),and Karaya gum, 28

05 02 04 05 04 01 23 12 02 02 02 10

(Sterculia gum). Number of lectures Total number of lectures

22 45

Recommended Books: [1] Corrado Tringali, [2]

[3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14]

Bioactive Compounds from Natural Sources: Isolation, Characterization and Biological Properties. CRC Press, 2000. Edward Joseph Shellard, Practical Plant Chemistry for Pharmacy Students. Pitman Medical, 1957. Ghillean T. Prance, Derek Chadwick, Joan Marsh, Ethnobotany and the Search for New Drugs: Symposium. J. Wiley, 1994. Gunnar Samuelsson, Drugs of Natural Origin: A Textbook of Pharmacognosy. Apotekarsocieteten, 1999. Iqbal Ahmad, Farrukh Aqil, Mohammad Owais, Modern Phytomedicine: Turning Medicinal Plants Into Drugs. Wiley-VCH, 2006. Jean Bruneton, Caroline K. Hatton, Pharmacognosy, phytochemistry, medicinal plants. Lavoisier, 1999. Jeffrey B. Harborne. Phytochemical Methods: A Guide to Modern Techniques of Plant Analysis. Springer, 1998. Jocelyn G. Millar, K. F. Haynes, Methods in Chemical Ecology: Chemical Methods. Springer, 1998. John C. Lindon, Jeremy K. Nicholson, Elaine Holmes. The Handbook of Metabonomics and Metabolomics. Elsevier, 2007. John T. Romeo. Integrative Phytochemistry: From Ethnobotany to Molecular Ecology. Elsevier, 2003. Joseph Sherma, Bernard Fried, Handbook of Thin-layer Chromatography, CRC Press, 2003. Kazuki Saito, Richard Arthur Dixon, Lothar Willmitzer, Plant Metabolomics. Birkhuser, 2006. Khandelwal K. R., Practical Pharmacognosy, Pragati Books Pvt. Ltd. Kokate C. K., Gokhale SB and Purohit AP, Pharmacognosy., Nirali Prakashan,

CG-201 P- Advanced Pharmacognosy-II (Practical) Duration: 6 Hrs/ week

Sr. No Name of experiment No. of Experiments

Isolation and purification of phytoconstituents using column chromatography, preparative TLC and flash chromatography 2. Study of fingerprint pattern of extract recorded by HPTLC and/or IR used to trace adulteration/ ontogenic and geographical variations 3. HPTLC/HPLC quantification of extracts using appropriate phytochemical markers 4. Extraction of galactomannan from Gaur gum Demonstrations 6. Study of the effect of different methods of extraction on volatile oil composition using GC 7. Determination of molecular properties of phytochemicals using computational softwares (eg. Molecular Modeling Interface Maestro v8.20 software. Schrodinger LLC, USA, Chem Draw etc) 8. Working and applications of Micro-titer Plate Reader Note: Minimum 12 experiments are compulsory Recommended Books

1.

06 03 05 01 01 01 01

[1] Kokate C. K., Practical Pharmacognosy, Vallabh Prakashan, 1993. [2] Leland J. Cseke, Ara Kirakosyan, Peter B. Kaufman, Sara Warber, James A. Duke. Natural
29

Products from Plants. CRC Press, 2006. [3] Lixin Zhang, Ph. D. Lixin Zhang, Arnold L. Demain, Natural Products Drug Discovery and Therapeutic Medicine. Springer, 2005. [4] Mahmud Tareq Hassan Khan, Mahmud T H Kahn, Arjumand Ather, Lead Molecules from Natural Products: Discovery and New Trends, Elsevier. [5] Manuchair S. Ebadi, Pharmacodynamic Basis of Herbal Medicine. CRC Press. [6] Maurice M. Iwu, Jacqueline C. Wootton. Ethnomedicine and Drug Discovery. Elsevier. [7] Michael Heinrich, Joanne Barnes, Simon Gibbons, Elizabeth M. Williamson. Fundamentals of Pharmacognosy and Phytotherapy. Elsevier Health Sciences. [8] Michael J. Korenberg, Microarray Data Analysis: Methods and Applications. Published by Springer. [9] Nadkarni A. K. Indian Materia Medica: With Ayurvedic, Unani-tibbi, Siddha, Allopathic, Homeopathic, Naturopathic and Home Remedies. Popular Book Depot, [10] Nikolaus H. Fischer, Murray B. Isman, Modern phytochemical methods. [11] Nobuhiro Fusetani. Drugs from the Sea. Karger Publishers, 2000. [12] Norman Grainger Bisset, Max Wichtl. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis. Medpharm Scientific Publishers. [13] Patil, D.A., Flora of Dhule and Nandurbar Districts (Maharashtra), 2003. Bishen Singh Mahendra Pal Singh, Dehra Dun, India [14] Patwardhan, Bhushan. Drug Discovery and Development: Traditional Medicine and Ethnopharmacology. New India Publishing. [15] Pullaiah T. Biodiversity in India. Daya Books. [16] Raaman, N., Phytochemical Techniques. New India Publishing. [17] Rangari Vinod. D., Text book of Pharmacognosy and Phytochemistry Vol. I and II. [18] Richard P. Steiner, Folk Medicine: The Art and the Science. ACS. [19] Robert H. Marchessault, Polysaccharides for Drug Delivery and Pharmaceutical Applications (ACS Symposium). Oxford University Press. Annotation, 2006. [20] Satyajit D. Sarker, Zahid Latif, Alexander I. Gray. Natural Products Isolation. Springer. [21] Seetharaman Vaidyanathan, George G. Harrigan, Royston Goodacre, Metabolome Analyses: Strategies for Systems Biology, Springer. [22] Severian Dumitriu, Polysaccharides: Structural Diversity and Functional Versatility. CRC Press. [23] Stephen J. Cutler, Horace G. Cutler. Biologically Active Natural Products: Pharmaceuticals. CRC Press. [24] Steven M. Colegate, Russell J. Molyneux. Bioactive Natural Products: Detection, Isolation, and Structural Determination. CRC Press. [25] Thomas Edward Wallis, Practical Pharmacognosy. Churchill. [26] Thomas Edward Wallis, Textbook of Pharmacognosy. Little, Brown, Boston. [27] Thomas Eisner, Jerrold Meinwald. Chemical Ecology: The Chemistry of Biotic Interaction. National Academies Press. [28] Trevor Robinson. The Organic Constituents of Higher Plants: Their Chemistry and Interrelationships. Cordus Press, 1991. Original from the University of Michigan Digitized [29] Varro E. Tyler, Arthur Ernest Schwarting, Experimental Pharmacognosy.Burgess Pub. Co., 1962.

30

M.PHARMACY

PHARMACEUTICS Branch Code : PH

Semester I MT-100- Modern Analytical Techniques (Theory): Refer page no. 11-18

MT-100P Modern Analytical Techniques (Practical): Refer page no. 11-18 PH-101 Advanced Pharmaceutics I(Theory) Duration: 3 Hrs/week Total Hours: 45 Aim and Objectives: After studying this subject student will get insight into preformulation studies, formulation aspects, evaluation of formulations.
Section-I Topic Preformulation:-Techniques for physico-chemical characterization of Drug and excipient significance and methods for evaluation of drug-excipient, excipientexcipient and drug containers/closures interactions and incompatibilities. 2 Solid :- Recent techniques for particle size enlargement and micronizationsignificance and recent advancement, Compatibility and compressibility, different methods of evaluation of lubricant efficiency. 3 Dissolution & Dissolution Testing :- Theories of drug dissolution, dissolution test apparatus, selection of dissolution medium, dissolution of different dosage form solids, suspensions, topical, suppositories and controlled release systems. Enhancement of dissolution rate. Biopharmaceutical classification system, In-vivo dissolution techniques, in vitro models for evaluation. Number of Lectures Section-II 4 Dosage form design aspects Physiochemical aspect: pKa, Partition coefficient, Polymorphism & crystal habbits, solubility etc. Biological aspects: Role of physicochemical parameters on drug absorption and their implications, routes of administrations and implication on bioavailability. 5 Surfactant & polyphasic system :- Phase behavior of surfactant in binary and ternary Systems. Factors affecting phase behavior. Micellization micelle structure, shape, size factor affecting CMC and micellar size, thermodynamics and kinetics of micelle formation. Pharmaceutical aspects of solubilization in non-aqueous systems, interaction with polymers and oppositely charged species. SEDDS & SMEDDS, Multiple emulsions, Ternary & Pseudoternary phase diagrams, Zeta potential. 6 Solubility enhancement by solid dispersions, complexation, micronization and cosolvency. Number of Lectures Total number of Lectures Sr.No. 1 31 Hours 06 05 12

23 07

12

03 22 45

PH-101 P- Advanced Pharmaceutics I (Practical) Duration: 6 Hrs/week Sr. Name of Experiment no. 1 Drug Excipient Interaction IR, UV, TLC, DSC
Heckel plot analysis and lubricant sensitivity. Comparative evaluation of intrinsic dissolution rate of drug crystallized from different solvents. 4 Dissolution testing of different types of dosage forms (minimum 5) 5 Ternary phase diagram of surfactant system. 6 Solubility determination. 7 Solubility enhancement of drug by micronization. 8 Effect of compression force on dissolution rate. 9 Development of dissolution media. 10 Particle size determination by various techniques. 11 Preparation and characterization of solid dispersions. Note: Minimum 12 experiments are compulsory 2 3

No. of Experiment 03 01 01 05 01 01 01 01 01 01 01

Recommended Books for theory and practicals:

[1] Remingtons Pharmaceutical Sciences: Arthur Osal (Editor), Mack Publishing Company Easton, Pennsylvanin 10842. [2] Theory and practice of Industrial Pharmacy Leon Lachman, Herbert A. Lichman and Joseph L. Kanin. Varghese Publishing House, Bombay. [3] Essential of Physical Chemistry and pharmacy Arnikar, Kadam, Gujar, Orient Longman. [4] Quality Control in The pharmaceutical Industry: Volumes 1,2 and 3, Murrary S. Copper Academic Press, New York and academic Press London. [5] Good Manufacturing Practices for pharmaceuticals A plan for total Quality Control. [6] S. H. Willing, M. M. Tuckermanm S. Hilchings, Marcel Dekker, Inc. New York. [7] Pharmaceutical Preformulation by J. I. Wells, John wiley & sons, N.Y. [8] Chemical Stability of Pharmaceutics A Handbook for Pharmacists Kenneth A Connors, Gordon L. Amidon. Voluation J. Stelle, John Wiley & Sons, New York. [9] Pharmaceutical Dosage Forms: Parenteral Medications Volumes 1, 2 and 3. Kenneth E. Vavis, Loan Lachman and Herbert A. Lichman. Marcel Dekker New York. [10] Pharmaceutical Dosage Froms: Diperse System Vol. 1 & 2 Edited by as 13. [11] Pharmaceutical Dosage Forms: Tablets Volumes 1, 2 and 3. [12] Sterile Dosage Forms, Salvatore Turbo and Rebest E. King Lea and Febiger, Philadelphia. [13] Pharmaceutics The Sciences of Dosage Form Design Michael E. Aulton, Churchill Livingstone, New York. [14] Advances in Pharmaceutical Sciences, Edited by Bean, Bockett and Carless, Academic Press, New York. [15] Dermatological Formulation Percutaneout Absorption. Srian W. Berry, Marcel Dekker Inc. New York. [16] Physical Pharmacy: A. N. Martine, James Swerbrick and Commarate (Lea & Febiger, Philadelphia) [17] Pharmaceutical Pelletization Technology, Isaac Ghebre Sellaassie, Mercel Decker Inc. [18] Pharmaceutical Dissolution Testing, U.V.Bankar, Mercel Decker Inc. [19] Bentleys Textbook of Pharmaceutics, Edited by Davidson. [20] Lee & Robinson, Controlled Drug Delivery, Second Edition, Mercel Decker Inc.

32

Semester II MT-200 Drug Regulatory Affairs and Intellectual Property Rights (Theory): Refer page no. 11-18 MT-300 - Research Methodology and Biostatistics ( Theory): Refer page no. 11-18 PH-201 Advanced PharmaceuticsII( Theory ) Duration: 3 Hrs/week Total Hours: 45

Aim and Objectives: After studying this subject student will get insight into different drug delivery systems including ocular, transdermal and mucoadhesive. Section-I Sr. No. 1 2 3 4 Topic Basic Considerations of novel drug delivery systems: Biopharmaceutical aspects and technology transfer of CDDS. Oral drug delivery systems: Based on different control mechanism such as Osmotic pressure, membrane controlled pH, ion-exchange, gastroretentive, pulsatile, colon specific etc. Microencapsulation:- Applications, various techniques, factors affecting stability, manufacturing equipments. Transdermal drug delivery: Percutaneous absorption, Formulation, in-vitro and in-vivo evaluation. Hours 02 12 05 04 23 16

Number of Lectures Section-II 5 Mucosal drug delivery: - Physiological, biopharmaceutical considerations, formulation and models used. a) Buccal :- Physiology and permeability of oral mucosa, penetration enhancement, drug delivery systems and invitro and in-vivo techniques. b) Pulmonary: - Structure and function of pulmonary system, factors affecting deposition in lungs. Dosage forms: Nebulizers, pressurized inhalation aerosols, aerosol powder. c) Nasal :- Anatomy and physiology of nasal mucosa, penetration Enhancers, formulation development, in-vitro, ex-vivo and in-vivo methods of evaluation. d) Rectal :- Physiology, advantages, dosage forms and evaluation models. 6 Intrauterine and intravaginal drug delivery- Physiology, Formulation & Evaluation 7 Ocular drug delivery:Mechanism and development of ocular drug delivery. Number of Lectures Total number of Lectures

03 03 22 45

33

PH-201 P- Advanced Pharmaceutics II ( Practical) Duration: 6 Hrs/week Sr.No. 1 2 3 4 5 6 7 8 9 Note: Name of Experiment Formulation and Evaluation of sustained release tablets Formulation & Evaluation of gastro retentive drug formulation, Floating mucoadhesive tablets / beads / microspheres. Formulation & Evaluation of colon specific drug delivery system Preparation and evaluation of microcapsules / microspheres. Preparation and evaluation of transdermal patches. In-vitro permeation studies across skin and nasal mucosa. ( animal & Artificial membrane) Formulation & Evaluation of a) Liposome b) multiple emulsion. Formulation & Evaluation of sustained release rectal/vaginal products. Formulation & Evaluation semisolid preparations. Minimum 12 experiments are compulsory. No. of Experiment 02 03 01 01 01 02 02 01 02

Recommended Books for theory and Practicals [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19] [20] P. Tyle; Drug Delivery Devices, fundamental and applications; Marcel Dekker. Morton Rosoff; Controlled release of drugs; VCH Publishers. Osborne, and Amann; Topical drug delivery formulations; Marcel Dekker. P. Tyle; Drug delivery devices: Marcel Dekker. Barry: Dermatological formulation; Marcel Dekker Robinson; Novel Drug Delivery systems; Marcel Dekker N.K. Jain; controlled and novel drug delivery; CBS Publication, New Delhi P. Johnson and J. G. Lloyd Jones; Drug delivery systems; VCH Publisher P. Tyle and B. P. Ram; Targeted therapeutics systems; Marcel Dekker. C.G. Wilson & N. Washington; Physiological Pharmaceutics; Ellis Horwood Limited. H.S. Bean, A.H. Beckett, and J.E. Carless; Advances in Pharmaceutical Sciences; Vol. 5, Academic Press. R. O. Potts, and R.H. Guy; Mechanisms of transdermal drug delivry; Marcel Dekker T.J. Roseman and S.Z. Mansdorf; Contolled release delivery systems; Marcel Dekker A.J. Hickey; Pharmaceutical Inhalation Aerosol Technology; Marcel Dekker. J. Kreuter; Controlled drug delivery system; Marcel Dekker P.B. Deasy; Microencapsulation and related drug processes; Marcel Dekker. Pharmaceutical Pelletization Technology, Isaac Ghebre Sellaassie, Mercel Decker Inc. Pharmaceutical Dissolution Testing, U.V.Bankar, Mercel Decker Inc. Bentleys Textbook of Pharmaceutics, Edited by Davidson. Lee & Robinson, Controlled Drug Delivery, Second Edition, Mercel Decker Inc.
34

M.PHARMACY

QUALITY ASSURANCE
Branch Code : QA

35

M.PHARMACY QUALITY ASSURANCE Branch Code : QA

Semester I MT-100- Modern Analytical Techniques (Theory): Refer page no. 11-18 MT-100P Modern Analytical Techniques ( Practical) : Refer page no. 11-18 QA-101 Quality Assurance I (Theory) Duration: 3 Hrs/week Total Hours: 45 Aim and Objectives: To explain the students about various regulatory agencies, Quality control, Quality assurance, documentation and their role in quality assurance, designing of validation protocol and validation documents. Beside this course will provide students insight into quality assurance department in the pharmaceutical industry. The role of quality assurance department in todays context and how important this department is in any pharmaceutical set up. Section-I Sr.No. Topic 1 Introduction: - An understanding of the concepts of quality assurance, GMP & cGMP, QC, IPQC and QA as applied to the pharmaceutical industry. 2 Quality Assurance Documents: - Internal audits, SOP, document security and storage related issues. 3 Mfg. Documents :- Product development stage documentation, BMR, MFR, routine records downtime records, calibration and validation records, Retention records. 4 Validation related documents :- Validation and types of validation, Protocols, methodology and related GMP/ICH guidelines. Number of Lectures Section-II 5 New Drug Application:- NDA and ANDA requirements, data presentation, verification and grant by FDA. 6 Good Laboratory Practices ( GLP ) :- Regulations, biological evaluation of microbiological limit tests, sterility tests for effectiveness of antimicrobial preservatives, LD50, ED50, teratogenicity, mutagenecity, clinical trials, bioassays, pyrogens and pyrogen testing. 7 Related Quality System :- ISO, WHO and their application in pharmaceutical Industry. TQM, Six Sigma methodology. 8 Pharmaceutical Packaging : Introduction to pharmaceutical packaging, types of packaging material, Quality Control of packaging material such as glass, plastic, papers etc. Number of Lectures Total number of Lectures
36

Hours 04 04 06 08 22 04 07

06 06 23 45

QA-101 P- Quality Assurance -I (Practical) Duration: 6 Hrs/week Sr.No. 1 2 3 4 5 6 7 Name of Experiment To determine the tensile strength of various polyethylene films those are used for bulk packaging of pharmaceuticals. To determine the tensile strength of polymer films used in the formulation. To determine the bursting strength of the cartoons used for packaging of pharmaceuticals using bursting strength apparatus. To determine the puncture resistance strength of the packaging materials using puncture resistance tester. To determine the water holding capacity of various packaging material using Cobbs tester Physicochemical evaluation of glass containers used for parenterals preparations Physicochemical evaluation of plastic containers used for packaging of Pharmaceutical preparations. Sterility testing of LVP Sterility testing of Ophthalmic preparation Microbial limit test of starch, acacia , gelatin as per Pharmacopoeia No. of Experimen t 03 01 01 01 01 01 01 02 02 03

8 9 10 Note: Minimum 12 experiments are compulsory Recommended Books for theory and Practicals [1] Pharmaceutical Quality Assurance, M.A. Potdar, Nirali Prakashan, Pune. [2] Current Good Manufacturing Practices, M.A. Potdar, Pharma-Med Press, Hyderabad.
th

[3] GMP for Pharmaceuticals, 5 Edition, Sidney H. Willing, Marcel Decker Series [4] Regulatory guidelines related to GMP by a. b. c. d. [5] [6] [7] [8] [9] [10] [11] [12] Australian code of GMP for medicinal products, 16 Aug. 2002. 21 Code of Federal Regulation, parts 210, 211 & 58. (USFDA guidelines) MHRA, UK Guidelines on GMP GMP Guidelines by Medicines Control Council of South Africa Schedule M of D & C Act Assurance of Quality, Pharmaceutical Total Quality Approach, M. S. P. Khan, Chitgaon, Bangladesh, Signet Press-1990 Packaging of Pharmaceuticals & Healthcare Products, Lockhard, Pharmaceutical Packaging, F.A.Paine, Quality Control of Packaging Materials in the Pharmaceutical Industry, Kenneth & Harburn, Mercel Decker Inc. Validation of active Pharmaceutical Ingredients by, I.R. Berry and Daniel Harpar. Analytical Method validation and Instrument Performance Verification by Churg Chan, Heiman Lam, Y.C. Lee, Yue. Zhang, Wiley Interscience. Guidelines on cGMP and Quality of Pharmaceuticals product by S. Iyer Quality Control of Packaging materials in the Pharmaceutical Industry by Kenneth and Hanbinn, M. Dekker. Inc.
37
th

[13] [14] [15] [16] [17] [18] [19] [20] [21] [22] [23] [24]

Pharmaceutical Master Validation plan by S. Haiden, CRC press. Handbook of Packaging Engineering II edition by J.F. Hanlon. Packaging of pharmaceutical and health care products lockharth. Good laboratory practices by Weinberg sandy. Good clinical laboratory and manufacturing by Carson P.A. Good laboratory practice and regulations by Mohanan P.V. Good manufacturing practices for pharmaceutical by willing Sidney. Quality manual by D.H. Shan. Validation of pharmaceutical process by Conleton F. Intellectual property rights and biodiversity by Swansan T. ISO-14000 issues and implementation Lamplecht J.A. Pharmaceutical process validation by R.A. Nash and Wachta A.H., Mercel Dekker inc. [25] Drugs and Cosmetics Act and rules 1940.

38

II semester MT-200 Drug Regulatory Affairs and Intellectual Property Rights (Theory): Refer page no. 11-18 MT-300 - Research Methodology and Biostatistics ( Theory): Refer page no. 11-18 QA-201 Quality Assurance -II (Theory) Duration: 3 Hrs/week Total Hours: 45 Aim and Objectives: To explain the students about various regulatory agencies, Quality control, Quality assurance, documentation and their role in quality assurance, designing of validation protocol and validation documents. Beside this course will provide students insight into quality assurance department in the pharmaceutical industry. The role of quality assurance department in todays context and how important this department is in any pharmaceutical set up. Section-I Topic Introduction: - An understanding of the concepts of quality assurance, QA tools & Techniques. 2 Analytical method development and validation as per ICH guidelines 3 Process Validation: - Sterile and non sterile process validation, Cleaning validation, Product validation (Solid & liquids), Validation Protocols, methodology and interpretation of data. 4 Equipment Validation: - Installation qualifications and operational qualification, performance qualification of different equipments like autoclave, oven, filter. Number of Lectures Section-II 5 Rules and Regulations :- Drug and Cosmetic Act and Rules, Narcotic drugs and Psychotropic substances Act and Rules, Magic Remedies and Objectionable Advertisement Act, Environment Protection Act. 6 Regulatory authorities:TGA, MHRA, USFDA, WHO, ICH Sr.No. 1 7 8 9 Patent processing and its applications, Intellectual Property Rights (Patents, Copyrights & Trademarks) Pilot plant scale up techniques and Technology transfer Optimization Techniques Hours 05 08 05 04 22 06 07 04 02 04 23 45

Number of Lectures Total number of Lectures

39

QA-201 P- Quality Assurance II (Practical) Duration: 6 Hrs/week Sr.No. 1 2 3 4 5 Name of Experiment Validation of Equipments like Autoclave, Oven, Filter, Dissolution Tester, Tablet Compression Machine. Development and Validation of Analytical method. Formulation Development & its validation Determination of efficiency of preservatives. No. of Experiment 02 04 02 01 02

Validation of processes like mixing, drying and compression. Note: Minimum 12 experiments are compulsory Recommended Books for theory and Practicals : [1] Forensic Pharmacy by B.S. Kuchekar, A. M. Khadatare and S. C. Jitkar, 6 Ed., Nirali Prakashan [2] Drugs and Cosmetics Laws by Krishnan Arora, Professional Book Publishers, New Delhi [3] Mittal B.M., A Textbook of Forensic Pharmacy, 9 Ed., Vallabh Prakashan [4] Deshpande S.W., Drugs and Cosmetic Act.1940 [5] Deshpande S.W, Drug and Magic Remedies Act 1954. [6] P. Warayan, Intellectual Property Laws, Eastern Law House. [7] Drug and Cosmetic Act 1940, Eastern Book company by Vijay Malic, 11th Ed. Patents for Medicine, by N. B. Zareri, Indian Drug Manufacturers Association (IDMA) [8] Pharmacy Law and Ethics by Dale and Appelbes, The Pharmaceutical Press, Joy Winfield. [8] R.A. Nash & A.H. Wachter, Pharmaceutical Process Validation, Mercel Decker Inc. [9] Carleton F. J and Agallow J.P., Validation of Aseptic Pharmaceutical [10] Processes, Mercel Decker Inc. [11] S. Haider, Pharmaceutical Master Validation Plan, CRS press. [12] Chung Chan, Herman Lam, Y.C. Lee, Zuv Zhang, Analytical Method Validation & Instrument Performance Verification, Wiley I nterscience. [13] I.R. Berry, Daniel Harpaz, Validation of Active Pharmaceutical Ingredients.
th th

40

M.PHARMACY

PHARMACOLOGY
Branch Code : PL

41

M.Pharmacy

PHARMACOLOGY Branch Code : PL

Semester I MT-100- Modern Analytical Techniques (Theory): Refer page no. 11-18 MT-100P Modern Analytical Techniques ( Practical) : Refer page no. 11-18 PL 101 Advanced Pharmacology-I (Theory) Duration: 3 Hrs/week Sr.no 1 Total Hours: 45

Section -I Topic Hrs 9 Mechanism of drug action: Receptor and their classification, specificity of receptor, Signal transduction, G-protein coupled receptors, Receptor occupancy and cellular signaling system such as G-proteins, cyclic nucleotides, calcium and phosphatidylinositol, Ion channels and their modulators. 16 2 Preclinical screening of the drugs acting on i) Autonomic nervous system: Parasympathomimetics, Parasympatholytics, Sympathomimetics,Sympatholytics ii) Central nervous system- Sedatives, hypnotics, anxiolytics, antidepressants, antipsychotics, analgesics, antipyretics, anticonvulscents, antiparkinsonian iii) Cardiovascular system- Cardiac glycosides, antiarrhythmic, antithypertensives, iv) Respiratory system- bronchodilators, antitussives, Antiasthmatics 25 Number of lectures Section II 14 3 In vitro drug screening methods, High throughput screening of drugs, alternatives to animal testing in drug discovery, Modern techniques in the Pharmacological screening of drugs. In silico drug screening. Knowledge of Modern Methods of Pharmacological evaluations including radioligand binding assay, patch clamp, ELISA, and other sophisticated methods like microarray techniques, Chemiluminiscence, Flow cytometry, Immunohistochemistry 6 4 Pharmacogenetic disorders, Concept of gene therapy and recent development in the treatment of various hereditary diseases, Human genome mapping and its potential in drug research. Transgenic animals. Methods of preparation of transgenic animals and their uses. 20 Number of lectures 45 Total number of lectures
42

Recommended Books: [1] Laurence DR, Bacharach AL, editors. Evaluation of drug activities: Pharmacometrics. (1965) London and New York: Academic Press; [2] Goodman and Gilmans The pharmacological Basis of Therapeutics. Joel G. Hardman, Lee E. Limbird (Editors), 10th Edition (2005) Mcgraw Hill Medical Publishing Division. [3] Nodine JH and Siegler PE. (Editors). Animal and Clinical Pharmacological Techniques in Drug Evaluation. (1964). Year Book Medical Publishers. [4] Turner RA and Hebborn P. Screening Methods in Pharmacology. Vol 1 and 2. 2nd Edition. (1965-71), New York, Academic Press. [5] Goldstein A, Aronow L, Kalman SM. Principles of drug action. The basis of pharmacology. (1974) New York: John Wiley and Sons. [6] Vogel HG (Ed.) Drug Discovery and Evaluation, Pharmacological Assay. Coeditors: Vogel WH, Scholkens BA, Sandaw J, Muller G, 2nd edition (2002). Springer Verlog Berlin Heidelberg. [7] Review articles published in various journals

PL 101 P-Advanced Pharmacology I ( Practical) Duration: 6 Hrs/week Sr. no 1 Number of experiments CPCSEA regulations, Maintenance of experimental animals, Animal 01 house facility as per regulations, Procedure for registration of animal house facility, Different forms, Constitution, role and responsibility of IAEC 01 Introduction to experimental animals, Methods of breeding, Biological (Scientific name, special characteristics, food and water intake, uses, strains etc.), normal physiological and biochemical values of various parameters Handling and drug administrations to experimental animals. 1 10-13 Screening of drugs acting on CNS: Neurobehavioral screening as per Irwins method, Elevated plus maze, Water maze, Zero maze, Chemically and electrically induced convulsions, actophotometer, analgesiometer, Acetic acid induced writhings, Clonidine induced twitches, plethysmometer, catalepsy, hot plate test, Rota rod, pole climbing, histamine chamber 01 Introduction to use of Physiographs in experimental Pharmacology, Demonstration of invasive Rat blood pressure experiment, ECG, EEG etc EP-DOG (simulation of dog blood pressure experiment) 01 01 Use of anesthetics and cannulation of veins, arteries and trachea of rat. Demonstrations of methods of collection of blood from experimental animals, Various methods of euthanasia. Identification of phases of estrous cycle in rats Name of Experiment

3 4

5 6 7

8 Note: Minimum 12 experiments are compulsory

43

Recommended Books [1] Ghosh MN. Fundamentals of Experimental Pharmacology. 4th Edition, (2008) Hilton and Company, Kolkata. [2] Robert A. Turner and Peter Hebborn. Screening Methods in Pharmacology. Vol I and II, 2nd Edition, (1965 -71) Academic Press, New York. [3] Ian Kitchen. Textbook of In vitro practical pharmacology. (1984) Blackwell Science Publication, Oxford. [4] Laurence DR, Bacharach AL. (Eeditors). Evaluation of drug activities: pharmacometrics. (1965) London and New York: Academic Press. [5] Sheth UK, Dadkar NK, Kamat G. and Usha G. Selected Topics in Experimental Pharmacology. (1972) The Kothari Book Depot, Bombay. [6] Pharmacological Experiments on Isolated Preparations. (1968) University of Edinburgh. Edinburgh and London: E. and S. Livingstone. [7] Baselt R C. Analytical Procedures for Therapeutic Drug Monitoring and Emergency Toxicology. 2nd edition (1987). Recommended Journals: Indian Journal of Pharmacology Indian Journal of Physiology & Pharmacology Journal of Experimental Pharmacology and Therapeutics Indian Journal of Experimental Biology Annual Reviews in Pharmacology and Toxicology Pharmacological Review ILAR (Institute for laboratory animal research) Journal Laboratory Animal Semester -II MT-200 Drug Regulatory Affairs and Intellectual Property Rights( Theory) : Refer page no. 11-18 MT-300 - Research Methodology and Biostatistics ( Theory): Refer page no. 11-18

PL-201- Advanced Pharmacology II(Theory) Duration: 3 Hrs/week Sr. no 1 2 3 4 5 6 Topic Preclinical screening of drugs acting on Gastrointestinal tract Autacoids Immune system Fc-receptors on T and B lymphocytes, Antibody dependent and cellular cytotoxicity.- Anti-inflammatory Endocrine system- Hypoglycemics, Anti-thyroid agents Urinary system- Diuretics Reproductive system- antifertility agents, androgens Number of lectures
44

Total Hours: 45 Hrs 03 04 06 02 02 03 20

7 8 8 9

Section II Preclinical screening of the drugs acting on Anticancer drugs. Antitumor agents Drug acting on life cycle of cell Haematopoietic system Introduction to molecular biology (Bioinformatics): Basics of DNA, RNA and protein, Structure of cell, cell reproduction, concept of gene, control of protein synthesis. Introduction to Southern Blots, Northern Blots, Western Blots, Cloning and Sub-cloning. Number of lectures Total number of lectures

05 05 06 09

25 45

Recommended Books: [1] Guyton AC. Hall JE. Textbook of Medical Physiology 11th edition (2005). Philadelphia: Saunders. [2] Best CH and Taylor NB. Physiological Basis of Medical Practice, 3rd Edition (1943). Williams and Wilkins, Baltimore, Md. [3] Jensen D. The Principles of Physiology, 2nd Edition (1980). Appleton-Century-Crofts. [4] Vander S. Luciano's Human Physiology: The Mechanisms of Body Function, Eric P. Widmaier, Boston University Hershel Raff, Medical College of Wisconsin Kevin T. Strang, University of Wisconsin - Madison. [5] Goodman and Gilmans. The pharmacological Basis of Therapeutics Hardman JG, Limbird LE (Editors). 10th Edition, (2005), Mcgraw Hill Medical Publishing Division. [6] Nodine JH and Siegler PE (Editors), Animal and Clinical Pharmacological Techniques in Drug Evaluation. (1964) Year Book Medical Publishers. [7] Turner RA and Hebborn P. Screening Methods in Pharmacology Vol 1 and 2, 2nd Edition, (1965-71), New York, Academic Press. [8] Goldstein A, Kalman AL. Principles of drug action. (1974) The basis of pharmacology. New York: John Wiley and Sons. [9] Crossland Lewis's Pharmacology 4th edition, Churchill Livingstone, Edinburgh and London, (1971). [10] Katzung BG. Basic and clinical pharmacology, 9th edition, (2004) New YorkSydney-Chicago-Toronto: Lange. [11] Bacq ZM, Capek R, Paoletti R. and Renson J. Fundamentals of Biochemical Pharmacology. (1971), Pergamon Press, Oxford. [12] Laurence DR, Bennett PN, Brown MJ. Clinical Pharmacology. 8th edition (1997) Mc Graw-Hill Company, New York, Churchill Livingstone, Singapore. [13] Vogel HG (Ed.) Drug Discovery and Evaluation, Pharmacological Assays. Vogel WH, Scholkens BA, Sandaw J, Muller G. (coeditors), 2nd edition (2002). Springer-Verlog Berlin Heidelberg. [14] Laurence DR, Bacharach AL. (Editors). Evaluation of drug activities: Pharmacometrics. (1965). London and New York: Academic Press. [15] Rothstein, MA (Editors). Pharmacogenomics: Social, Ethical, and Clinical Dimensions (2003) Wiley-Liss, Hoboken, New Jersey. [16] Lesk, AM. Introduction to Bioinformatics. (2003), Oxford University Press, New Delhi. Review articles published in various journals.
45

PL-201 P- Advanced Pharmacology - II (Practical) Duration :6 Hours/Week Sr. no 1 2 3 Name of Experiment Determination of PA2, PD2 values of different drugs. Determination of LD50 of drug Bioassays of drugs on different isolated tissue preparations like rat ileum, guinea pig ileum, rat stomach strip, rat anococcygeus muscle, guinea pig trachea and other suitable preparations. e.g. Ach, Histamine, oxytocin, Pancuranium, 5-HT Study of antagonism e.g. Atropine, cyproheptidine Determination of effect of different drugs on rat blood pressure experiments Electrophoresis Isolation of DNA and RNA using commercially available kits Drug mutagenicity study using mice bone-marrow micronucleus test. Restriction digestion of DNA using commercially available kits Isolation of plasmids using commercially available kits Number of experiments 04 01 06

4 5 6 7 8 9

03 01 01 01 01 01

Note: Minimum 12 experiments are compulsory

Recommended Books [1] Ghosh MN. Fundamentals of Experimental Pharmacology. 4th Edition (2008) Hilton and Company, Kolkata. [2] Turner RA and Peter H. Screening Methods in Pharmacology Vol 1 and 2, 2nd Edition (1965 -71) New York, Academic Press. [3] Kitchen Ian. Textbook of In vitro practical pharmacology. (1984), Blackwell Science Publication, Oxford. [4] Laurence DR, Bacharach AL (Editors). Evaluation of drug activities: pharmacometrics. (1965), London and New York: Academic Press. [5] Sheth UK, Dadkar NK, Kamat G. and Usha G. Selected Topics in Experimental Pharmacology. (1972). The Kothari Book Depot, Bombay. [6] Perry Pharmacological Experiments on Isolated Preparations. (1968). By the Staff of the Department of Pharmacology, University of Edinburgh. Edinburgh and London: E. & S. Livingstone. [7] Baselt RC. Analytical Procedures for Therapeutic Drug Monitoring and Emergency Toxicology, 2nd edition (1987). Wright. [8] Thompson EB. Fundamentals of Drug Evaluation Techniques in Pharmacology. (1985), Graceway Publishing Company, New York. Recommended Journals: Indian Journal of Pharmacology Indian Journal of Physiology & Pharmacology Journal of Experimental Pharmacology and Therapeutics Indian Journal of Experimental Biology Annual Reviews in Pharmacology and Toxicology Pharmacological Review
46

M.PHARMACY

CLINICAL PHARMACY
Branch Code: CP

47

M.PHARMACY

CLINICAL PHARMACY Branch code: CP

Semester I MT-100- Modern Analytical Techniques (Theory): Refer page no. 11-18 MT-100P Modern Analytical Techniques ( Practical): Refer page no. 11-18 CP-101 Pharmacotherapeutics and Clinical Pharmacy I( Theory) Duration: 3 Hrs/ week Total Hours: 45

Aim and objective : This course is designed to impart knowledge and skills necessary for contribution to quality use of medicines. Chapters cover briefly Pathophysiology, therapeutics of various diseases & Clinical Pharmacy. This will enable the student to understand the Pathophysiology of common diseases and their management. Upon completion of course, the student should be able to know --a. The Pathophysiology of selected disease states and the rationale for drug therapy; b. The therapeutic approach to management of these diseases; c. To identify the patient-specific parameters relevant in initiating drug therapy (including alternatives, time-course of clinical and laboratory indices of therapeutic response and adverse effects). d. Importance & different facet of clinical Pharmacy. Sr. No. Topics Section I Pathophysiology and pharmacotherapy of following diseases/disorders. Cardiovascular System Atherosclerosis, Hypertension, Congestive cardiac failure, Angina pectoris, Myocardial infarction, Arrhythmias, Drug induced diseases. Respiratory system Asthma, Chronic obstructive pulmonary diseases, Pneumonia, Drug induced diseases. Hematological diseases Anaemias, thromboembolic disorders, Drug induced diseases. Diseases of joints Rheumatoid arthritis, osteoarthritis, gout, Drug induced diseases. Gastrointestinal system Peptic ulcer, reflux oesophagitis, gastroenteritis, inflammatory bowel
48

Hours

1 2 3 4 5

09 03 03 03 04

diseases, hepatitis, jaundice, cirrhosis, drug induced diseases. Number of lectures Section II 6 7 Definition, Development and Scope of Clinical Pharmacy Introduction to Daily activities of a Clinical Pharmacist a. Drug therapy monitoring (medication chart review, clinical review, pharmacist interventions) b. Ward round participation c. Adverse drug reactions & management Drug information and poisons information a) Introduction to drug information resource available b) Establishing a drug information centre c) Systemic approach in answering DI queries d) Critical evaluation of drug information and literature e) Preparation of written and verbal reports f) Poison informations -organization and information resources g) Medication history h )Patient counseling i) Drug utilization evaluation (DUE) and review (DUR) j) Quality assurance of clinical pharmacy services Patient data analysis a) Understanding of common medical abbreviation and terminologies use in clinical pharmacy. b) Patient medication record, Patient case history, its structure and use in evaluation of drug therapy. c) Patient counseling techniques d) Medication history Interview e. Presentation of cases Prescribing guidelines for Pediatric patients, Geriatric patients, Pregnancy and nursing mother. Patient Compliance Number of lectures Total Number of lectures

22 01 03

08

05

10 11

04 02 23 45

Recommended Books [1] [2] [3] [4] [5] [6] G.Parthasarathi , Karin Nyfort Hansen , Milap C. Nahata ; 2004, A Textbook Of Clinical Pharmacy Practice-Essential Concepts and skills,1st edition , Orient Longman Pvt. Ltd.,Chennai. Clinical Pharmacy & Therapeutics- Roger & Walker, Churchill Livingston publications. Pharmacotherapy: A Pathophysiologic Approach- Joseph T. Dipiro et al, Appletone & Lange. Robinson SL, Pathologic Basis of Disease ,WB Saunders Publications. karen Baxter ; Stockleys Drug Interaction 7th edition ,2006, pharmaceutical press London Chicago. Kanai L Mukherjee; Medical Laboratory Technology-a procedure,manual for routine diagnostic tests volume(I-III), 4th edition,1999 Tata mc Graw-Hill New
49

[7]

Delhi. Harsh Mohan ; Textbook of Pathology 5th edition,2005 , Jaypee Brothers Medical Publisher Pvt. Ltd. New Delhi. [8] Christopher Haslett, Edwin R . Chilvers, John A.A. Hunter, Nicholas A. Boon. , Stanley Davidson, Principle And Practice Of Medicine 18th edition,1999, Churchill Livingstone Publisher , Edinburgh [9] Chi Jen lee, Lucia H Lee, et.al. Clinical Trials Of Drugs And Biopharmaceutical1st edition, 1996,CRC Taylor & Francis group broken sound parkway, NW, Suite. [10 Harrisons Dennis kasper, Anthony s Fauci , Dan L Longo, Engene Braunwald, Stephan Hauser , J Larry Jamson, 2006, Principle Of Internal Medicine Vol I 16th edition Mc Graw Hill companies ,inc. USA. [12] Julia Lloyed , Ann Raven, ,Hand Book Of Clinical Research 2nd edition , 2006Churchill livingstone Edinburgh, London, Tokyo [13] Pathology and Therapeutics for Pharmacists: A Basis for Clinical Pharmacy Practice- Green and Harris, Chapman and Hall Publications. [14] Clinical Pharmacy & Therapeutics- Eric T Hefindal. Williams & Wilkins Publications. [15] Applied Therapeutics: The Clinical Use of Drugs. Lloyed Young and Koda- Kimble [16] Averys Drug Treatment, 4 th Edn 1997, Adis International Ltd [17] Basic skills in interpreting laboratory data- Scott L T. American Society of Health System Pharmacists. Recommended Journals: Indian Journal of Medical Research Indian Journal of Hospital Pharmacy Indian Journal of Clinical Practice Indian Journal of Pharmacy Practice International Journal of Community Pharmacy Annals of Pharmacotherapy New England Journal of Medicine Lancet International Journal of Pharmacy practice UK Hospital Pharmacist, UK International Journal of Clinical Practice CP-101 P- Pharmacotherapeutics and Clinical Pharmacy-I (Practical) Duration: 6 hrs/ week Aim and Objectives: Hospital postings of students in various departments designed to complement the lectures by providing practical clinical discussion, attending ward rounds and follow up the progress, also is required to understand the principles and practice involved in ward round participation and clinical discussion on selection of drug therapy, follow up the progress and changes made in drug therapy in allotted patients.

50

Sr.no.

Name of Experiment

No. of Experiments

Students are expected to perform practicals in the following areas covering the topics dealt in theory class: a. Answering drug information questions* b. Patient medication counseling* The cases being studied and their follow up studies should be recorded in the practical record books highlighting Subjective, Objective, Assessment and plan details on each case. Each student should collect at least 02 medical cases of each diseases/disorder they have observed and followed in the wards. A minimum of 15 cases should be recorded covering following diseases : ** 1. Hypertension 2. Congestive cardiac failure 3. Myocardial infarction 4. Arrhythmias 5. Asthma 6. Anaemia 7. Rheumatoid arthritis 8. Osteoarthritis 9. Gout 10. Peptic ulcer 11. Hepatitis 12. Atherosclerosis 13. Angina pectoris 14. Pneumonia. Note: Use and interpretation of biochemical data with its significance (Rational behind performing following test) * 1. Determination of blood glucose level 2. Determination of total lipid profile 3. Determination of Glycosylated hemoglobin (HbA1c) 4. Pregnancy test 5. Widal test 6. Determination of sodium, calcium and potassium in serum

05 05 15

05

** Major experiment * Minor experiment Note: Minimum 12 experiments are compulsory. Recommended Books [1] Karen Baxter ; Stockleys Drug Interaction 7th edition ,2006 pharmaceutical press London Chicago. [2] Ivan H. Stockley ; Drug Interaction 3rd edition ,1994,Blackwell Scientific Publication , London. [3] G.Parthasarathi , Karin Nyfort Hansen , Milap C. Nahata ; A Textbook Of Clinical Pharmacy Practice-Essential Concepts and skills,1st edition ,2004 Orient Longman Pvt. Ltd.,Chennai. [4] Harsh Mohan ; Textbook of Pathology 5th edition ,2005, Jaypee Brothers Medical Publisher Pvt. Ltd. New Delhi. [5] Christopher Haslett, Edwin R . Chilvers, John A.A. Hunter, Nicholas A. Boon. Stanley Davidson, Principle And Practice Of Medicine 18th edition , 1999,Churchill
51

Livingstone Publisher , Edinburgh Kanai L Mukherjee; Medical Laboratory Technology-a procedure,manual for routine diagnostic tests volume I, 4th edition, 1999,Tata mc Graw-Hill New Delhi. [7] Kanai L Mukherjee; Medical Laboratory Technology-a procedure,manual for routine diagnostic tests volume II, 4th edition,1999, Tata mc Graw-Hill New Delhi. [8] Kanai L Mukherjee; Medical Laboratory Technology-a procedure,manual for routine diagnostic tests volume III, 4th edition,1999,Tata mc Graw-Hill New Delhi. [9] Chi Jen lee, Lucia H Lee, et.al. Clinical Trials Of Drugs And Biopharmaceutical 1st edition, 1996, CRC Taylor & Francis group broken sound parkway, NW, Suite. [10] David machin et.al. Textbook of clinical trials 1st edition ,2005, Jonh Wiley & sons Ltd , Chichester, England . [11] Harrisons Dennis kasper, Anthony s Fauci , Dan L Longo, Engene Braunwald, Stephan Hauser , J Larry Jamson, 2006, Principle Of Internal Medicine Vol I 16th edition Mc Graw Hill companies ,inc. USA. [13] Harrisons Dennis kasper, Anthony s Fauci , Dan L Longo, Engene Braunwald, Stephan Hauser , J Larry Jamson, Principle Of Internal MedicineVol II 16th edition ,2006,Mc Graw Hill companies ,inc. USA. [14] David A. Warrell, Timothy M.Cox, John D firth, Edward J Benz ,Oxford textbook of medicine vol 1, 4th edition ,2006, Oxford University Press, Clarendon Street ,Oxford . 5/). [15] David A. Warrell, Timothy M.Cox, John D firth, Edward J Benz ,Oxford textbook of medicine vol II., 4th edition , 2006,Oxford University Press, Clarendon Street, Oxford . [16] David A. Warrell, Timothy M.Cox, John D firth, Edward J Benz ,Oxford textbook of medicine vol III., 4th edition ,2006, Oxford University Press, Clarendon Street, Oxford . [17] Julia Lloyed , Ann Raven, 2006 ,Hand Book Of Clinical Research 2nd edition Churchill livingstone Edinburgh, London, Tokyo . Recommended Journals: Indian Journal of Medical Research Indian Journal of Hospital Pharmacy Indian Journal of Clinical Practice Indian Journal of Pharmacy Practice International Journal of Community Pharmacy Annals of Pharmacotherapy New England Journal of Medicine Lancet International Journal of Pharmacy practice UK Hospital Pharmacist, UK [6] Semester II MT-200 Drug Regulatory Affairs and Intellectual Property Rights ( Theory ): Refer page no. 11-18

MT-300 - Research Methodology and Biostatistics ( Theory): Refer page no. 11-18

52

CP-201 Pharmacotherapeutics and Clinical Pharmacy II(Theory) Duration: 3 hrs/ week Total Hours : 45

1. Aim and objectives: This course is designed to impart knowledge and skills necessary for contribution to quality use of medicines. Chapters cover briefly Pathophysiology, therapeutics of various diseases & Clinical Pharmacy. This will enable the student to understand the Pathophysiology of common diseases and their management. 2. Upon completion of course, the student should be able to know -a. The Pathophysiology of selected disease states and the rationale for drug therapy b. The therapeutic approach to management of these diseases c. To identify the patient-specific parameters relevant in initiating drug therapy, (including alternatives, time-course of clinical and laboratory indices of therapeutic response and adverse effects). d. Importance & different facet of clinical Pharmacy. Sr No Topics Section I Pathophysiology and pharmacotherapy of the following diseases/disorders. Renal System Acute/Chronic renal failure, Renal dialysis and transplantation, Pyelonephritic, nephrotic syndrome, UTI, Central Nervous System Alzheimers disease, headache, epilepsy, Parkinsonism, neuralgias. Endocrine system Diabetes mellitus, Thyroid disorders, Osteoporosis. Psychiatric diseases Schizophrenia, depression, anxiety, sleep disorders, psychosis. Infectious diseases Tuberculosis, leprosy, Meningitis, Endocarditis, Malaria, helmenthiasis, HIV& AIDS. Neoplasia General principle of cancer chemotherapy, commonly use cytotoxic drugs, chemotherapy of lung cancer, cytological malignancy, management of nausea and vomiting Section -II Clinical laboratory tests used in the following diseases/disorders a. Hematology b. Cardiology c. Haepatology d Diabetology & Thyroid function e Urology f Gastroenterology g Pulmonary Function Tests Pharmacovigilance
53

Hours

1 2 3 4 5 6

03 03 04 03 07 03

08

04

a. Scope, definition and aims of Pharmacovigilance b. Adverse drug reactions & its management Clinical Pharmacokinetics a. Clinical pharmacokinetic models b. Physiological determinants of drug clearance and volumes of distribution c. Renal and non-renal clearance d. Organ extraction and models of hepatic clearance e. Estimation and determinants of bioavailability f. Multiple dosing g. Calculation of loading and maintenance doses Dose adjustment in renal failure, hepatic dysfunction, geriatric and pediatric patients Total Number of Lectures

10

45

Recommended Books: [1] G.Parthasarathi , Karin Nyfort Hansen , Milap C. Nahata ; A Textbook Of Clinical Pharmacy Practice-Essential Concepts and skills,1st edition , 2004,Orient Longman Pvt. Ltd.,Chennai. [2] Clinical Pharmacy & Therapeutics- Roger & Walker, Churchill Livingston publications. [3] Pharmacotherapy: A Pathophysiologic Approach- Joseph T. Dipiro et al, Appletone & Lange. [4] Robinson SL, Pathologic Basis of Disease ,WB Saunders Publications. [5] karen Baxter ; Stockleys Drug Interaction 7th edition ,2006, pharmaceutical press London Chicago. [6] Kanai L Mukherjee; Medical Laboratory Technology-a procedure,manual for routine diagnostic tests volume(I-III), 4th edition,1999 Tata mc Graw-Hill New Delhi. [7] Harsh Mohan ; Textbook of Pathology 5th edition,2005 , Jaypee Brothers Medical Publisher Pvt. Ltd. New Delhi. [8] Christopher Haslett, Edwin R . Chilvers, John A.A. Hunter, Nicholas A. Boon. , Stanley Davidson, Principle And Practice Of Medicine 18th edition,1999, Churchill Livingstone Publisher , Edinburgh [9] Chi Jen lee, Lucia H Lee, et.al. Clinical Trials Of Drugs And Biopharmaceutical 1st edition, 1996,CRC Taylor & Francis group broken sound parkway, NW, Suite. [10] Harrisons Dennis kasper, Anthony s Fauci , Dan L Longo, Engene Braunwald, Stephan Hauser , J Larry Jamson, 2006, Principle Of Internal Medicine Vol I 16th edition Mc Graw Hill companies ,inc. USA. [11] Julia Lloyed , Ann Raven, ,Hand Book Of Clinical Research 2nd edition , 2006Churchill livingstone Edinburgh, London, Tokyo [12] Pathology and Therapeutics for Pharmacists: A Basis for Clinical Pharmacy PracticeGreen and Harris, Chapman and Hall Publications. [13] Clinical Pharmacy & Therapeutics- Eric T Hefindal. Williams & Wilkins Publications. [14] Applied Therapeutics: The Clinical Use of Drugs. Lloyed Young and Koda-Kimble MA (ISBN-0333-65881-7) [15] Averys Drug Treatment, 4 th Edn 1997, Adis International Ltd [16] Basic skills in interpreting laboratory data- Scott L T. American Society of Health System Pharmacists.
54

Recommended Journals : Indian Journal of Medical Research Indian Journal of Hospital Pharmacy Indian Journal of Clinical Practice Indian Journal of Pharmacy Practice International Journal of Community Pharmacy Annals of Pharmacotherapy New England Journal of Medicine Lancet International Journal of Pharmacy practice UK Hospital Pharmacist, UK International Journal of Clinical Practice

CP-201P- Pharmacotherapeutics and Clinical Pharmacy -II(Practical)

Duration: 6 Hrs/ week Aim and Objectives : Hospital postings of students in various departments designed to complement the lectures by providing practical clinical discussion, attending ward rounds and follow up the progress, also it is required to understand the principles and practice involved in ward round participation and clinical discussion on selection of drug therapy, follow up the progress and changes made in drug therapy in allotted patients.
Sr.no Name of Experiment No. of Experiments

(1) Students are expected to perform practicals in the following areas covering the topics dealt in theory class:* a. Reporting of Adverse drug reaction b. Assessment with respect to drug interactions in the given prescriptions The cases being studied and their follow up studies should be recorded in the practical record books highlighting Subjective, Objective, Assessment and plan details on each case. Each student should collect at least 02 medical cases of each diseases/disorders they have observed and followed in the wards. A minimum of 15 cases should be recorded covering following diseases:** 1. Acute renal failure 2. Chronic renal failure 3. Diabetes Type-I 4. Diabetes Type-II 5. Hyperthyroidism 6. Hypothyroidism 7.Migraine 8. Epilepsy 9. Parkinsonism 10.Alzhemiers 11. Tuberculosis
55

05 05 10-13

3 1) 2) 3) 4) 5) 6)

12. Meningitis 13 Malaria 14 HIV 15. Neoplsia Note: Use and interpretation of biochemical data with its significance (Rational behind performing following test) Estimation of SGOT in serum* Estimation of SGPT in serum.* Estimation of Urea in Serum* Estimation of Proteins in Serum* Determination of serum bilirubin* Determination of blood creatinine*

07

* minor experiment ** major experiment Note: Minimum 12 experiments are compulsory Recommended Books: [1] Karen Baxter ; Stockleys Drug Interaction 7th edition ,2006 pharmaceutical press London Chicago. [2] Ivan H. Stockley ; Drug Interaction 3rd edition ,1994,Blackwell Scientific Publication , London. [3] G.Parthasarathi , Karin Nyfort Hansen , Milap C. Nahata ; A Textbook Of Clinical Pharmacy Practice-Essential Concepts and skills,1st edition ,2004 Orient Longman Pvt. Ltd.,Chennai. [4] Harsh Mohan ; Textbook of Pathology 5th edition ,2005, Jaypee Brothers Medical Publisher Pvt. Ltd. New Delhi. [5] Christopher Haslett, Edwin R . Chilvers, John A.A. Hunter, Nicholas A. Boon. Stanley Davidson, Principle And Practice Of Medicine 18th edition , 1999,Churchill Livingstone Publisher , Edinburgh [6] Kanai L Mukherjee; Medical Laboratory Technology-a procedure,manual for routine diagnostic tests volume I, II and III 4th edition, 1999,Tata mc Graw-Hill New Delhi. [7] Chi Jen lee, Lucia H Lee, et.al. Clinical Trials Of Drugs And Biopharmaceutical 1st edition, 1996, CRC Taylor & Francis group broken sound parkway, NW, Suite. [8] David machin et.al. Textbook of clinical trials 1st edition ,2005, Jonh Wiley & sons Ltd , Chichester, England . [9] Harrisons Dennis kasper, Anthony s Fauci , Dan L Longo, Engene Braunwald, Stephan Hauser , J Larry Jamson, 2006, Principle Of Internal Medicine Vol I & II 16th edition Mc Graw Hill companies ,inc. USA. [10] David A. Warrell, Timothy M.Cox, John D firth, Edward J Benz ,Oxford textbook of medicine vol 1, 4th edition ,2006, Oxford University Press, Clarendon Street ,Oxford . 5/-). [11] David A. Warrell, Timothy M.Cox, John D firth, Edward J Benz ,Oxford textbook of medicine vol II., 4th edition , 2006,Oxford University Press, Clarendon Street, Oxford . [12] David A. Warrell, Timothy M.Cox, John D firth, Edward J Benz ,Oxford textbook of medicine vol III., 4th edition ,2006, Oxford University Press, Clarendon Street, Oxford . [13] Julia Lloyed , Ann Raven, Hand Book Of Clinical Research 2nd edition , 2006Churchill livingstone Edinburgh, London, Tokyo .
56

Recommended Journals Indian Journal of Medical Research Indian Journal of Hospital Pharmacy Indian Journal of Clinical Practice Indian Journal of Pharmacy Practice International Journal of Community Pharmacy Annals of Pharmacotherapy New England Journal of Medicine Lancet International Journal of Pharmacy practice UK Hospital Pharmacist, UK International Journal of Clinical Practice

57

LIST OF ELECTIVE SUBJECTS

For M.Pharm. -I and M.Pharm. -II Sem.

58

List of Elective Subjects

M.Pharm.-I Semester

M11
M11 Advanced Medicinal Chemistry(Theory)
Duration: 3 Hrs/ week Total Hours: 45

Aim and Objectives:The course is designed to provide detail knowledge about approaches involved in the action of drug molecule. Upon completion of course, the student should be able to Know the effect of drug action by binding with various targets. Study the pharmacodynamics of drug action through its metabolism. Study the designing of new drug molecule through Prodrug approach. Sr. No. 1. Section -I Topic Receptorology Drug receptor interaction, Receptor theories and drug interaction, occupancy theory, rate theory, induced fit theory, macomolecular pertuburation theory, activation aggregation theory, topological and stereochemical consideration. Enzyme inhibition. Enzyme structure: Primary, Secondary, Tertiary, Quaternary. Enzyme kinetics, Enzyme inhibitors, reversible, irreversible, keats inhibitors, transition state analogs. Enzyme inhibitors as drugs ACE, leukotriens, lipoxygenase, aromatase, xanthine oxidase, DNA polymerase inhibitors, HIV protease / Reverse transcriptase, integrase, cytochrome P 450 inhibitors. Number of lectures SECTION II Drug Metabolism. General Pathways of Drug metabolism, Catalytic cycle of cytochrome P 450, Human cytochrome P 450 isoforms; their classification and nomenclature, induction and inhibition of P 450 isoforms, Biological factors affecting drug metabolism, Structure metabolism relationship, Oxidative reactions of aliphatic / alicyclic hydrocarbons, alkenes, alkynes, aromatic hydrocarbons, N and S dealkylation, and oxidation, O dealkylation, dehalogenation, A 20 and nitroreductase, Phase II pathways, Metabolism and toxicity of drugs. Metabolism and drug designing. Designing and applications of Prodrugs.
59

Hrs. 09

2.

13

22 14

3.

4.

Prodrug concept. Prodrugs of various functional groups. Application of Prodrug approach to improvement of bioavailability, prevent first pass metabolism, reduction of side effects, prolong duration of action, site specific delivery 23 Number of lectures 45 Total number of lectures Recommended Books: [1] Burger: Medicinal Chemistry (John Wiley & Sons N.Y.) [2] Foye: Principal of Medicinal Chemistry (Varghese & Co.) [3] Ariens: Medicinal Chemistry Series [4] Ellis and West: Progress in Medicinal Series [5] Butterworther: Progress in Medicinal Chemistry Series [6] Wilson and Gisvolds Text book of Medicinal Chemistry (J. B. Lippincoff cam) [7] Comprehensive Medicinal Chemistry Series I-VI (Academic Press)

60

M12
M 12. Technology of Bulk Drug(Theory)
Duration: 3 Hrs/ week Total Hours: 45

Aim and Objectives : The course is designed to provide detail knowledge about approaches involved manufacture of drugs. Upon completion of course, the student should be able to know The chemical processes used in the manufacture of drugs Te importance of unit operation for drug synthesis. The Safety and hazards in chemical reactions Section-I Topic Hrs. 12 a. Stoichiometry and its importance in the manufacturing of drugs b. Discussion in the following process ( Reaction types in relation to manufacturing of drugs) ----Acetylation, Nitration, Sulfonation, Chorosulfonation, Oxidation, reduction, Alkylation, Halogenation, Carboxylation, Decarboxylation,Esterification, Addition, Epoxidation and important rearrangements 10 2. Unit process : Study of the following chemical process( with reference to reagent, mechanism, equipment and manufacture of drugs given below) Acylation, Etherification, Alkylation, Amination, Halogenation, Hydrolysis, Nitration, Oxidation, Reduction. 22 Number of lectures Section -II 07 3. Further discussion on unit operation important to drug synthesis e.g. Mixing, Distillation, Drying, Filtration, Centrifugation, Evaporation, Crystallization, Counter current extraction , Effluent treatment and pollution control 07 4. Principle and Design of Reactors : Factors to be considered ( including material selection) construction of flow diagram and selection of equipments 06 5 Detailed manufacturing aspects, inclusive of process and operation involved for aspirin, adrenaline, Barbitones, Benzocaine, Chloramphenicol, Sulfathiazole, 6 Safety and Hazardous concepts 03 23 Number of lectures 45 Total number of lectures Recommended Books [1] M.G. Larians Fundaments of chemical Engineering Operations [2] W.L. Badger and Banchero , Introduction to chemical Engineering , Mc Graw Hill
61

Sr. No. 1.

[3] L. Lachman, Theory and Practice of Industrial Pharmacy [4] Ganderton G., Unit Processes in Pharmacy [5] Groggin P.K. Unit Process in Organic Synthesis Mc Graw Hill Publications [6] Marshall Sitting, Organic Chemical Process [7] Dryden C.L., Outline of Chemical Technology ( Affiliated East West Press Pvt. Ltd.)

62

M13
M 13 Plant Cell and Tissue Culture(Theory)
Duration: 3 Hrs/ week Sr. No 1. Total Hours: 45 Hrs 10

2.

3.

4.

Section -I Topics Plant tissue culture theory and methods Introduction to plant tissue culture and cell suspension culture, physico-chemical conditions for propagation of plant cells and tissues, composition of media, nutrient and hormone requirement, continuous culture, techniques for immobilization of plant cells. Plant tissue culture product and recovery Primary and secondary metabolic products (phytochemicals) of plant cells, biosynthesis of secondary metabolites of biotechnological importance, Strategies to enhance the production of secondary metabolites such as use of physical and chemical stressors (i.e. optimization of culture conditions, media and phytohormones), Use of precursor feeding methods, and elicitation using biotic and abiotic ellicitors. Continuous product recovery system using immobilized plant cell system. Biotransformation for product development and selection of cell culture, process technology with salient features for specific products. Number of lectures Section-II Plant tissue culture genetic engineering Structure and organisation of plant genome, regulation of plant genome expression, transcriptional, translational and post transcriptional regulation of plant genome. Transposons, chloroplast and mitochondrial genome. Plant tissue culture genetic engineering Transfer of genetic material to plant cells Direct transformation: Electroporation, particle gun bombardment, macro and microinjection, Liposomes, ultrasonication and chemical mediated gene transfer. Agrobacterium-mediated transfer: Ti plasmid vector Localization of transferred gene in genetically modified plants Nucleic acid hybridization Use of radioisotopes and molecular markers Theory and techniques for the development of new genetic traits, conferring resistance to herbicide, pesticide, plant pathogens. Plant engineering towards development of enriched food products, plant growth regulators. Application of transgenic plants and their regulatory aspects in India with case study of BT Cotton and BT Brinjal. Number of lectures Total number of lectures

13

23 10

12

22 45

Recommended Books
63

[1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11]

Balasubramaniam, Bryce, Dharmalingam, Green, Jayaraman, Concepts in Biotechnology, Univ. Press, 1996. Street H.E, Tissue culture and Plant science, Academic press, London, 1974. Roberta H. Smith, Plant Tissue Culture: Techniques and Experiments, Academic Press, 2000. ISBN 0126503427, 9780126503425. Sharma Balram, Plant Tissue Culture and Transformation Techniques, Daya Books, 2008. Jennie P Mather, Penelope E Roberts, Introduction to Cell and Tissue Culture: Theory and Technique, Springer, 1998. Dutta Gupta, Yasuomi Ibaraki, Plant Tissue Culture Engineering, Springer, 2006. John H. Dodds, Lorin W. Roberts, Experiments in Plant Tissue Culture, Cambridge University Press, 1995. ISBN 0521478928, 9780521478922. Sant Saran Bhojwani, M. K. Razdan, Plant Tissue Culture: Theory and Practice Elsevier, 1996. Vasil I. K., Perspectives in Plant Cell and Tissue Culture: Supplement 11, Part A: Perspectives in Plant Cell & Tissue Culture, Academic Press, 1980. Street Herbert Edward, Plant Tissue and Cell Culture, University of California Press,. Gregory Bock, Joan Marsh, Applications of Plant Cell and Tissue Culture: Symposium on Applications of Plant Cell and Tissue Culture, Held at the Kyoto Intern. Conf. Centre, Kyoto, 20.10.1987-22.10.1987, Wiley, 1988.

64

M14

M 14 Polymers in Pharmaceutics (Theory)

Duration: 3 Hrs/week Total Hours: 45 Aim and Objectives : After studying this subject student should get in depth knowledge of various polymers which finds applications in formulating various dosage forms. Section-I Topic Hours Classification of polymers, synthesis of polymers, general methods of 12 preparation of polymers like solution bulk, suspension and emulsion polymerizations. Properties of following commonly used polymers: Starch, cyclodextrins, chitosan, gelatin, albumin, Cellulose derivatives, acrylates and poloxamers. 2 Characterization of polymers: Molecular weight and Molecular 8 weight distribution of polymers, flow characteristics, crystallinity, solubility and thermodynamics of polymers solutions, biodegradability and biocompatibility testing of polymers. 03 3 Factors affecting selection of polymers, Effect of additives on polymer properties, Effect of environmental conditions on polymer properties, Polymer properties influencing drug permeation, Factors influencing kinetics of solute release. 23 Number of Lectures Section-II 4 Natural & Synthetic Acrylates and their applications 5 5 Biodegradable polymers and their application in pharmaceuticals 5 6 Application of polymers in sustained & controlled release drug 8 delivery system ( Oral, Mucosal, Transdermal) 7 Applications of polymers in new drug delivery systems. 4 22 Number of Lectures 45 Total number of Lectures Recommended Books : Sr.No. 1 [1] J. Brandrup, E.H. Immergur; Polymer Handbook; John Wiley and Sons. [2] Charles G. Gebelein, T.C. Chin and V. C. Yang; Cosmetic and Pharmaceutical Applications of Polymers; Plenum Press, New work. [3] D.S. Soane; Polymer Applications of Biotechnology; Prentice Hall Inc. [4] J. R. Robison and V. H. Lee; Controlled Drug delivery- Fundamentals and Applications; Marcel Dekker. [5] N.K. Jain; Controlled and Novel Drug Delivery; CBS publication. [6] P. J. Tarcha; Polymers for controlled Drug Delivery; CRC Press [7] A. F. Kydonieus: Controlled Release Technologies: Methods, Theory and Applications, Vol. I & II CRC press Inc.

65

M15
M 15 Industrial Pharmacy and Production Management(Theory)
Duration: 3 Hrs/week Total Hours : 45 Aim and Objectives : After studying this subject student should get the knowledge of pharmaceutical production management at industrial level. Sr.No. 1 Section-I Topic Hours 06 Pilot plant scale-up, pilot plant design: tablets, capsules liquid orals, parenteral and semisolid preparations. Basic requirement for design of product, facility equipments selection, personnel, pharmaceutical process validation for various products. Pharmaceutical Process Validation- Manufacturing processes for 05 Tablets, Liquid Orals, Injectables and semi solid dosage forms Optimization techniques: Optimization parameter, classical 05 optimization, statistical design and applied optimization methods. 05 Production planning: Plant site selection, layout and organization of pharmaceutical industries. Vendor development capacity (plant, machine human resources) assessment of production rate changes, inventory management costing of product and cost controls, planning product mix. Documentation: Manufacturing documents, IPQC documentation, 02 Product development stage documentation. 23 Number of Lectures Section-II 05 Quality Assurance: GMP consideration, quality assurance and process control, Good laboratory practices. Total quality management and productivity, Six Sigma Methodology, ISO 9000 series salient features. Drug and Cosmetics Act: Requirement related to manufacture and 05 sale of drugs. Safety: Industrial hazards due to fire, accident, mechanical and 04 electrical equipment chemical and pharmaceutical, monitoring and preventive system. Effluent testing and Treatment: For pharmaceutical industry. 02 04 02 22 45

2 3 4

7 8 9 10

Machinery Engineering: Introduction to mechanical, electrical and electronic parts of pharmaceutical machinery, equipments. Material handling for various pharmaceutical products. 11 Automation: Flexible manufacturing system, computer control system: data acquisition, distributed control and centralized control system. Typical models for solid and liquid manufacturing. Number of Lectures Total number of Lectures

66

Recommended Books: [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] P. R. Watt; Tablet machine instrument in pharmaceuticals: John Wiely and Sons. B. Rothery; ISO 14000 and ISO 9000; Grower. G. C. Cole: Pharmaceutical production facilities, Design and applications; Taylor and Francis J.R. Berry and R. A. Nash; Pharmaceutical process validation; Marcel Dekker S. Bolton; Pharmaceutical statistics; Marcel Dekker. S.H. Will and J.R. Stoker; good manufacturing practices for pharmaceuticals; Marcel Dekker. R. F. Brewe; Design of Experiments for process improvement and quality assurance; Narosa. A. Jaiswal; Management of quality control and standardization: Kanishka Publisher, New Delhi D.H. Stamatis: Understanding ISO 9000 and implementing the basics to quality; Marcel Dekker. P. Gilson, G. Green halgh and K. Kerr; Manufacturing management; Chapman and Hall. S.S. Rao; Optimization theory and applications; Wiley Eastern Limited. J. F. Despautz: Automation and validation of information in pharmaceutical processing; Marcel Dekker. J.M. Juran and A.B. Godfrey; Jurans Quality Handbook; McGraw Hill. S. N. Katjus Law and drugs; Law Publishers (I) Pvt. Ltd.

67

M16
M 16 New Drug Discovery Process(Theory)
Duration: 3 Hrs/week Section I Sr.no 1 Topic Recent trends on different classes of receptors and drugs acting on them a. Cholinergic receptors b. Dopamine receptors c. Serotonin receptors d. Hormone receptors e. GABA receptors f. Opioid receptors g. Purinergic receptors h. Glutamate receptors g. PPAR- Endothelium derived vascular substances (Nitric oxide, endothelins) and their modulators. Pharmacology of atrial peptides, reactive oxygen intermediates, antioxidants and their therapeutic implications Number of lectures Section II New Drug Discovery Process: New drug development process and drugs registration process, IND, NDA Clinical Trials. i) Ethical issues in clinical trials Principal, responsible conduct, supervision of ethics, (Informed Consent, Institutional Review Board (Role responsibility, members and auditing), Protection of participants, The Nuremberg Code, The Declaration of Helsinki, The Belmont Report, ii) Clinical trial design: Designs used in clinical trials with their advantages and disadvantages, hypothesis, risks and benefits, subject selection, inclusion and exclusion criteria, randomization, blinding and controls iii) Clinical trial protocol Development: Required Documentation including Investigator's Brochure, Case Report Forms, Serious Adverse Event (SAE) Reports, Laboratory Certification, data collection and quality control of data, closing out of clinical trial iv) Good Clinical Practice: Concept, importance, and GCP guidelines including ICH guidelines Pharmacovigilance: Definition, collection of data, reporting, assessment of Post marketing surveillance, periodic safety update reports, Riskbenefit assessment Number of lectures Total number of lectures 6 05 Hrs 13 Total Hours: 45

2 3

05 04 22 03 15

4 5

23 45

68

Recommended Books: [1] Katzung BG. Basic and clinical pharmacology, 9th edition, (2004), New York-SydneyChicago-Toronto: Lange. [2] Barrar FSK. Essentials of Pharmacotherapeutics, 4th Edition (2007), S. Chand and Company Ltd. New Delhi. [3] Bowman WC, Rand MJ. Textbook of Pharmacology, 2nd edition, (1980), Blackwell Scientific Publications, London. [4] Melman KI and Morelli HF: Clinical Pharmacology: Basic Principles in Therapeutics, McGraw-Hill, Medical Publishers [5] Craig CR, Stizel RE (Editors). Modern pharmacology. 4th edition, (1994), Boston (MA): Little Brown Co. [6] DRILL VA. Pharmacology in Medicine, 3rd edition (1965) McGraw Hill, New York. [7] Grollman A, Pharmacology and Therapeutics. (1954) Philadelphia: Lea and Febiger. [8] R. Raveendran, 'Research Methodology for undergraduates' (ReMe) [9] Rang and Dale, Pharmacology, 5th Edition, 2006, Elsevier, USA. Recommended Journals: Indian Journal of Pharmacology Indian Journal of Physiology & Pharmacology Journal of Experimental Pharmacology and Therapeutics Indian Journal of Experimental Biology Annual Reviews in Pharmacology and Toxicology Pharmacological Review

69

M17
M 17 Hospital and Community Pharmacy(Theory)
Duration: 3 Hrs/ week Total Hours: 45 1 Aim and objective :- In the changing scenario of pharmacy practice in India, for successful practice of Hospital & community Pharmacy, the students are required to learn various skills like drug distribution, drug dispensing, drug information, patient counseling, and therapeutic drug monitoring for improved patient care. 2. Upon completion of the course, the student shall be able to a. Know various drug distribution methods b. Know the professional practice management skills in hospital pharmacy. c. Implement the stores management and inventory control d. Practice total pharmaceutical care e. Know the business and professional practice management skills in community pharmacies f. Do patient counseling & provide effective health services to public in community pharmacy.
Sr. No. Topics Hours

Section I

1 2 3

Hospital organization: Pharmacy and Therapeutics Committee and role of hospital pharmacist. Hospital drug policy: Drug committee, Formulary and guide lines, other hospital committees such as infection control committee and research and ethics committee. Hospital pharmacy management: Staff (professional, nonprofessional) materials (drugs, non-drugs and consumables), financial (drug budget, cost centre, source of revenue, revenue collection), policy and planning, infrastructure requirements (building, furniture, specialized equipment, maintenance and repairs), Workload statistics. Drug distribution: Purchasing, warehousing (storage condition, expiry date control recycling of drugs, stock tacking, drug recalls), Drug distributing methods (Ward stock, individual patient dispensing, unit dose), Specific requirements for in patient, out patients, casualty/Emergency. Operation theatres, ICU/CCU, Drugs of dependence, Hospital waste management. Manufacturing: Sterile and non sterile production, including total parental nutrition, cytotoxic, radiopharmaceutical IV additives service, pre-packaging and labeling, Quality control. Education and training: Training of technical staff, Training and continuing education for pharmacists. Pharmacy student. Medical staff and student, Nursing staff and student, Formal and informal meeting and lectures, Drug and therapeutics news Letter. Ethical issues in biomedical research Principle f ethics in biomedical Research, good clinical practice (ICH GCP guideline), ethical committee (Institutional review board), its constitution and functions,
70

01 02 04

06

5 6

05 05

Ethics of Publication. 23 Number of lectures Section II 7 The role of community pharmacy and its relationships to other local 02 health care providers. 8 Prescribed mediation order - Interpretation and legal requirements, 03 communications skills- communications with prescribes and patients. 9 Over the counter (OTC) sales- Definition, OTC medication list & 01 counselling. 02 10 Primary healthcare in hospital pharmacy Family planning , first aid ,Participation in primary health care programs, Smoking cessation, Screening programs 11 03 Community pharmacy management a) Selection of site, Space layout, and design b) Staff, Materials- coding, stocking c) Legal requirements d) Maintenance of various registers e) Use of Computers: Business and health care soft wares 12 01 Code of ethics for community pharmacist 05 13 Pharmacoepidemiology: Definition and scope ,Methods ( Sources of data, study design, drug utilization studies, meta analysis), Social, cultural, economic factor influencing drug use. System for monitoring drug effects, Advantages and disadvantages of Pharmacoepidemiology 05 14 Pharmacoeconomic: Definition, history, needs of pharmacoeconomic evaluations Outcome assessment and types of evaluation, Includes theoretical aspects of various methods and practical study of various methods with the help of case studies for individual methods: Cost minimization, cost- benefit, cost effectiveness, cost utility 22 Number of lectures 45 Total Hours Recommended Books : [1] Hospital Pharmacy- Hassan W E, Lec and Febiger Publications. [2] Textbook of Hospital pharmacy- Allwood MC and Blackwell [3] Averys Drug Treatment, 4th Edition, 1997, Adis International Ltd. [4] Remingtons Pharmaceutical Sciences. [5] Handbook of pharmacy health care.Edt. Robin J Harman. The Pharmaceutical press. [6] Comprehensive Pharmacy Review Edt. Leon Shargel. Lippincott Williams & Wilkins. [7] Relevant review articles from recent medical and Pharmaceutical Journals Recommended Journals: Indian Journal of Medical Research Indian Journal of Hospital Pharmacy Indian Journal of Clinical Practice Indian Journal of Pharmacy Practice International Journal of Community Pharmacy Annals of Pharmacotherapy New England Journal of Medicine Lancet
71

International Journal of Pharmacy practice UK Hospital Pharmacist, UK International Journal of Clinical Practice

72

Semester II

M21 M 21. Drug Design (Theory)

Duration: 3 Hrs/week Aim and Objectives:The course is designed to provide detail knowledge about designing of drug right from the target chosen through the various parameters affecting on its action. Upon completion of course, the student should be able to know-The various routes of drug discovery through lead identification. The concept of pharmacogenomics. The approaches and various parameters of QSAR which are helpful to predict the biological activity. Analog design. Concept and application of molecular modeling using known and unknown receptors. Section-I Sr. No. 1. Topic Drug Discovery a) Historical Perspective b) Drug Discovery studies in Direct Drug Design( Structure based) ND Indirect Drug Design c) Target Selection and Lead Identification i) Natural Product Sources ii) Fermentation/ microbial sources iii) Synthetic d) Introduction to Pharmacogenomics Quantitative Analysis of Structure Activity Relationship a) History and development of QSAR b) Drug-Receptor Interactions c) Quantitative model parameters: lipophilicity, electronic and steric factors d) Hansch Analysis, Free Wilson analysis, relationship between them and their application. e)Statistical methods-regression analysis, partial-least square analysis (PLS) and other multivariate statistical methods 2D and 3D QSAR approaches. Number of lectures Hrs. 8 Total Hours: 45

2.

15

23

73

Sr. No. 3.

Section-II Topic

Hrs. 15

Molecular modeling Introduction to Molecular Modeling- concepts and methods a) Molecular mechanics-Force field (potential energy function) b) Quantum Mechanics- Calculation of affinity, unknown receptors, Pharmacophore models c) Known receptor sites d) Searching for similarity, molecular comparison and finding common pattern e) Energy Minimization methods-Steepest, desent, conjugate gradients, Newton methods (Non mathematical) f) Conformational Analysis i) Systematic search ii) Monte Carlo Simulations iii) Molecular Dynamics Simulations Ligand design based on 3D structure 3. Analog Design From Lead Molecule Introduction, Bioisosteric replacement, rigid analogs, alteration of chain branching, changes in ring size, ring position isomers, design of stereo isomers and geometric isomers, fragments of a lead molecule, variation in inter atomic distance. Number of lectures Total Number of lectures Recommended Books [1] [2] [3] [4] [5] [6] [7] [8] [9]

22 45

Ariens: Medicinal Chemistry Series. Ellis and West: Progress in Medicinal Chemistry Series. Butterworthser: Progress in Medicinal Chemistry Series. Burgers Medicinal chemistry-The Basis of Medicinal chemistry by Manfred E. Wolff part-I (John Wiley & Sons). Medicinal chemistry The Role of organic chemistry in drug research by S.M.Roberts and B.J.Price. Organic Chemistry of Drug Design and Drug Action R. B. Silverman Comprehensive Medicinal Chemistry Hansch and Leo.

74

M22

M 22 Biotechnology and Bioinformatics(Theory)

Duration: 3 Hrs/week Aim and Objective:The course is designed to provide detail knowledge about biotechnology and bioinformatics Upon completion of course, the student should be able to know Basics of genetics, recombinant DNA technology and its applications Basics of immunology, cell biology and Gene therapy Molecular structural and chemical biology and bioinformatics Section-I Sr. No. Topic 1. Genetics: Structure and function of DNA, DNA Replication and repair, expression of genetic information, structure and function of RNA , transcription, genetic code, translation, post translational modification 2. Recombinant DNA Technology : Constructing recombinant DNA molecules, restriction enzymes, vectors, gene cloning, genomic libraries, polymerase chain reaction based DNA cloning, Restriction mapping, blotting techniques, DNA sequencing, Pharmaceutical Applications of recombinant DNA 3 Gene Therapy : General Introduction, Potential target diseases for gene therapy, gene transfer methods, clinical studies, pharmaceutical production and regulation 4 Basic of Immunology and monoclonal antibodies and hybridoma technology and its applications: Vaccines- conventional vaccines, modern vaccines technologies, genetically improved live vaccines, genetically improved subunit vaccines, pharmaceutical consideration. Number of lectures Section-II 5 Fundamental of cell biology : Cell organization and plasma membrane: transport of substances across the membrane Cellular reproduction: Cell cycle mitosis and meiosis, apoptosis. Cell Signaling: Communication between cells and their environment Molecular biology of cancer : Causes of cancer and genetics of cancer , 6 New strategies for combating cancer 7 Molecular, structural and chemical biology in pharmaceutical research: Molecular biology of disease and in vivo transgenic models, genomic protein targets and recombinant therapeutics, structural biology
75

Total Hours: 45

Hrs. 05 06

05 07

23 06

04 06

and rational drug design, chemical biology and molecular diversity, gene therapy and DNA/ RNA targeted therapeutics. Future of pharmaceutical research Introduction to Bioinformatics : Biological data bases, sequence 06 8 analysis, protein structure, genetic and physical mapping, applications of bioinformatics in pharmaceutical industries Number of lectures 22 Total Number of lectures 45 Recommended books [1] Nelson D.L. and Coy M.M . Lehninger Principle of Biochemistry, Worth Publisher New York. [2] Karp G. Cell and Molecular Biology [3] Cromalin D.J. and Sindelar R.D. Pharmaceutical Biotechnology [4] Templeton N.S. and Lasic D.D. Gene Therapy [5] Benjamin Lewin, Genes [6] Lesk A. M. Introduction to Bioinformatics Oxford University Press New Delhi Indian Edition [7] Watson, Molecular Biology of Cell [8] Paul W.E. Fundamentals of Immunology [9] Glick B.R. and Pasternak J.J. Molecular Biotechnology ( ASM Press Washington) [10] Rastogi S.C., Mendiratta N. and Rastogi P. Bioinformatics concepts, skills and Applications CBS Publisher New Delhi

76

M23 M 23 Herbal Drug Development( Theory)

Duration: 3 hrs/ week Sr. No 1. Total Hours: 45

Section -I Topics Hrs 09 Herbal drug standardization 02 I. Concept of evaluation of herbal medicine as per WHO Guidelines. Fundamentals and comparative account of multi-component, multi-target phytotherapy and single-molecule, single-target Concept of modern medicine. 04 II. Conventional methods used in herbal drug standardization and their limitations. Sources of variation in chemical make-up of plant derived drugs: genotypic, ecotypic and biotypic variations and variations resulting during processing and storage. III. System biology approach for quality control of herbal drugs, 03 DNA micro-array technique. 2. Formulation development and quality assurance of herbal drugs 14 I. Difficulties in development of herbal formulations and possible 02 remedies to overcome these problems. II. Formulation of dried extracts, solid and liquid dosage forms and 04 their quality control using physical parameters. III. Stabilization and stability of herbal formulations, preservation 03 of liquid formulations. IV. Applications of Novel drug delivery systems for phytochemicals 02 V. Quality assurance in breeding, cultivation, harvesting, post03 harvesting, processing and storing of medicinal plants. 23 Number of lectures Section-II Pharmacological screening (in vivo and in vitro models) and 10 3 review of literature for the following categories of drugs Immunomodulatory, anticancer, antidiabetic, and hypolipidemic drugs. 4. 06 Nutraceuticals and functional foods Definition, classification, their regulation and current trends 5. 03 Global regulatory status of herbal drugs Regulatory status in India, USA, Germany, and Japan 6. 03 Clinical study of plant derived medicines 22 Number of lectures 45 Total number of lectures Recommended Books: [1] Chi-Jen Lee, Lucia H. Lee, Christopher L. Wu, Mei-Ling Chen, Benjamin R. Lee, Clinical Trials of Drugs and Biopharmaceuticals. CRC Press, 2005. [2] Clare M. Hasler, Regulation of Functional Foods and Nutraceuticals: A Global Perspective. Blackwell Publishing, 2005.
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[3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19] [20] [21] [22] [23] [24] [25] [26]

Gunnar Samuelsson, Drugs of Natural Origin: A Textbook of Pharmacognosy. Apotekarsocieteten, 1999.. Iqbal Ahmad, Farrukh Aqil, Mohammad Owais, Modern Phytomedicine: Turning Medicinal Plants Into Drugs. Wiley-VCH, 2006. Jean Bruneton, Caroline K. Hatton, Pharmacognosy, phytochemistry, medicinal plants. Lavoisier, 1999. Jeffrey B. Harborne. Phytochemical Methods: A Guide to Modern Techniques ofPlant Analysis. Springer. John C. Lindon, Jeremy K. Nicholson, Elaine Holmes. The Handbook of Metabonomics and Metabolomics. Elsevier, 2007. John Shi, G. Mazza, Marc Le Maguer, Functional Foods: Biochemical and Processing Aspects. CRC Press, 2002. John Shi, Jerry W. King, Functional Food Ingredients and Nutraceuticals: Processing Technologies. CRC Press, 2006. John T. Romeo. Integrative Phytochemistry: From Ethnobotany to Molecular Ecology. Elsevier, 2003. Kazuki Saito, Richard Arthur Dixon, Lothar Willmitzer, Plant Metabolomics. Birkhuser, 2006. Leland J. Cseke, Ara Kirakosyan, Peter B. Kaufman, Sara Warber, James A. Duke. Natural Products from Plants. CRC Press, 2006. Manuchair S. Ebadi, Pharmacodynamic Basis of Herbal Medicine. CRC Press, 2007. Melanie Johns Cupp, Toxicology and Clinical Pharmacology of Herbal Products. Humana Press, 2000. Michael Heinrich, Joanne Barnes, Simon Gibbons, Elizabeth M. Williamson. Fundamentals of Pharmacognosy and Phytotherapy. Elsevier Health Sciences, 2004. Michael J. Korenberg, Microarray Data Analysis: Methods and Applications.Published by Springer, 2007. Nikolaus H. Fischer, Murray B. Isman, Modern phytochemical methods. Plenum Press, 1991. Norman Grainger Bisset, Max Wichtl. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis. Medpharm Scientific Publishers, 1994. Pulok K. Mukherjee. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals. Business Horizons, 2002.Original from the University of Michigan Digitized Aug 19, 2008. Raaman, N., Phytochemical Techniques. New India Publishing. Robert E. C. Wildman, Handbook of Nutraceuticals and Functional Foods. CRC Press, 2007. Seetharaman Vaidyanathan, George G. Harrigan, Royston Goodacre, Metabolome Analyses: Strategies for Systems Biology, Springer. Stephen J. Cutler, Horace G. Cutler. Biologically Active Natural Products: Pharmaceuticals. CRC Press, 1999. Thomas Edward Wallis, Textbook of Pharmacognosy. Little, Brown, Boston],1960. Thomas Eisner, Jerrold Meinwald. Chemical Ecology: The Chemistry of Biotic Interaction. National Academies Press, 1995. Trevor Robinson. The Organic Constituents of Higher Plants: Their Chemistry and Interrelationships. Cordus Press, 1991. Original from the
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University of Michigan Digitized Jul 24, 2008. [27] William Charles Evans, George Edward Trease, Daphne Evans. Trease and Evans Pharmacognosy. W.B. Saunders, 2002. Original from the University of Michigan Digitized Aug 20, 2008.

Recommended Journals Biological and Pharmaceutical Bulletin Indian Drugs Indian Journal of Pharmacology Journal of Agriculture and Food Chemistry Journal of Chromatography Journal of Ethnopharmacology Journal of Natural Products Natural Product Reporter Phytochemistry Phytomedicine Phytotherapy Research Planta Medica

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M24 M 24 Novel Drug Delivery Systems ( Theory )

Duration: 3 Hours / Week Total Hours: 45 Aim and Objectives: After studying this subject, student will be updated with recent novel techniques of drug delivery systems. Section-I Sr.No. 1 2 Topic Hours 7 15 Molecular Basis of targeted drug delivery General consideration, methods of preparation, characterization and applications of Microspheres and microcapsules, resealed erythrocytes, nanoparticulate systems, solid lipid nano-particles, multiple emulsions and nanoemulsions. Number of Lectures Section-II 3 Overview and applications of of Aquasomes, Pharmacosomes, transferosomes, liquid crystalline systems, protein and peptide drug delivery system 4 General consideration, Characterization & evaluation of liposomes, niosomes, dendrimers, organogels Number of Lectures Total number of Lectures Recommended Books:

22 10 13 23 45

[1] Jain N.K., Controlled & Novel Drug Delivery, CBS Publications, New Delhi [2] Jain N.K., Advances in Controlled & Novel Drug Delivery, CBS Publications, New Delhi. [3] Vyas S.P. and Khar R.K., Controlled drug delivery- Concepts & Advances, Vallabh Prakashan, New Delhi. [4] Vyas S.P. and Khar R.K., Targeted & Controlled drug delivery- Novel Career System,. CBS Publications, New Delhi. [5] Chien Y, Novel Drug Delivery System, Mercel Decker Publications. [6] Lee & Robinson, Controlled Drug Delivery, Second Edition, Mercel Decker Publications. [7] Swarbrick J and Boylon J.C., Encyclopedia of Pharmaceutical Technology, Vol. 1-3, Mercel Decker Inc.

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M25 M 25. Sterile Dosage form Technology(Theory)

Duration: 3 Hrs/week Total Hours : 45 Aim and Objectives : After studying this subject student should get in depth knowledge of formulation of conventional and controlled release parenteral preparations, Ophthalmic products and their evaluations. Section-I Sr.No. Topic Hours 7 1 Preformulation: Physico-chemical properties of materials used in parenteral formulations, selection of polymeric components, selection of packaging components. 8 2 Formulation of SVP and LVP: Requirement, components, materials, Pharmacopoeial requirements, special types of parenteral such as suspensions, emulsions, dried forms, sterile diagnostics and radiopharmaceuticals. 8 3 Ophthalmic Products: Ocular anatomy and physiology relevant to ocular drug delivery, ocular pharmacokinetics, conventional ophthalmic products, ocular inserts, particulate and liposomal drug delivery, protein and peptide delivery. 23 Number of Lectures Section-II 4 Sustained Release Parenterals: Liposomes, and niosomes, 12 nanoparticles, proteins and peptides, implants, loaded erythrocytes. 10 5 Manufacturing of Parenterals: 1) Environmental Control: Temperature and humidity control, air handling systems and their validation. 2) Industrial sterilization: Large scale sterilization processes, process selection, specifications, development and validation of process and equipments. 3) Guidelines: Overview of GMP and regulatory guidelines. 22 Number of Lectures 45 Total number of Lectures Recommended Books : [1] K.E. Avis, H. A. Liberman and Lachman; Pharmaceutical dosage forms: Parenteral Medications; Vol. 1,2,3 Marcel Dekker. [2] S. J. Turco; Sterile dosage forms: their preparation and clinical application; Lee and Febiger [3] N. K. Jain; Controlled and novel drug delivery; CBS Publication. [4] J. R. Robinson and H. L. Lee; Controlled drugs delivery: Fundamental and Applications; Marcel Deker. [5] F.J. Carleton and J.P. Agalloco; Validation of aseptic pharmaceutical processes; Marcel Dekker. [6] L. A. Trissel; Handbook on injectable drugs; American Society for Hospital Pharmacist Publication. [7] N.A. Halls; Achieving sterility in medical and pharmaceutical products; Marcel and Dekker.
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M26

M 26 Safety Pharmacology and Toxicology(Theory)

Duration: 3 Hrs/week Sr.no 1 2 3 Total Hours: 45 Hrs 04 12 06 Topic Pharmacokinetic studies in Preclinical and clinical evaluation of drug. Safety Pharmacology: ICH guidelines S7A, S7B, Safety pharmacology evaluation: In vivo -Telemetry applications in safety pharmacology, In vitro - patch clamp technique, Langendorff isolated heart preparation. Documentation and protocol preparation, knowledge of planning, performing, analyzing, reporting and monitoring of safety pharmacology study. Number of lectures Section II OECD guidelines for toxicity testing Documentation and protocol preparation, knowledge of planning, performing, analyzing, reporting and monitoring of above toxicity. 6 Concept of 3 Rs, Alternatives to animals in toxicity testing, Methods to minimize the use of animals in safety Pharmacology and toxicology. Number of lectures Total number of lectures Recommended Books: [1] Toxicology Principles and Applications: R.J.M. Niesink, J. De Vries, M.A. Hollinger (eds), CRC Press, Boca Raton, New York, London, Tokyo, 1996. [2] Klassen C.D., Amdur M.O., Doul J Casaretts and Doulls Toxicology New York, McGraw Hill Publishing Ltd. 2001 [3] Gupta, P.K. and Salunkhe, D.K. Modern Toxicology. Volume I, II and III. Latest edition. Publisher: B.V. Gupta, Metropolitan Book Co. (p) Ltd, New Delhi. Recommended Journals: Indian Journal of Pharmacology Indian Journal of Physiology & Pharmacology Journal of Experimental Pharmacology and Therapeutics Indian Journal of Experimental Biology Annual Reviews in Pharmacology and Toxicology Pharmacological Review 4 5 12 05 06 23 45

22

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M27 M 27 Clinical Research(Theory)

Duration: 3 Hrs/ week Total Hours: 45

1. Aim and Objective - In the changing scenario of India in clinical research, the students are required to learn various skills like clinical development of drug, TDM, Ethical Guidelines for Human clinical Trials. 2. Upon completion of the course, the student shall be able to a. Know various clinical developments Process. b. Know the Regulatory requirements for IND Application & NDA Application. c. Know the various Guidelines for Clinical trials like ICH, GCP.
Sr.No. Topics Hours

Section I 1 Drug development process: a. Introduction b. Various Approaches to drug discovery c. Preclinical study information (Pharmacological& Toxicological e. IND Application Clinical development of drug: a. Introduction to Clinical trials b. Various phases of clinical trial. c. Methods of post marketing surveillance d. Abbreviated New Drug Application submission. e. Good Clinical Practice ICH, GCP, Central drug standard control organization (CDSCO) guidelines f. Challenges in the implementation of guidelines Ethical consideration in clinical development of drug: a. Ethical guidelines in Clinical Research b. Composition, responsibilities, procedures of IRB / IEC c. Overview of regulatory environment in USA, Europe and India. Number of lectures Section -II Ethical consideration in clinical development of drug: d. Role and responsibilities of clinical trial personnel as per ICH GCP i. Sponsor ii. Investigators iii. Clinical research associate iv. Auditors v. Contract research coordinators e. Regulatory authority f. Designing of clinical study documents (protocol, CRF, ICF, PIC with assignment) g. Informed consent Process h .Data management and its components i. Safety monitoring in clinical trials. Therapeutic Drug monitoring: a. Introduction b. Individualization of drug dosage regimen (Variability Genetic, Age and Weight, disease, Interacting drugs). c. Indications for TDM. Protocol for TDM.
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04

10

08

22 09

05

d. Pharmacokinetic/Pharmacodynamic Correlation in drug therapy. e. TDM of drugs used in the following disease conditions: cardiovascular disease, Seizure disorders, Psychiatric conditions, and Organ transplantations. 6 Drug Interaction: a. Pharmacokinetic drug interactions b. Classification , Mechanism & Management. 7 Pharmacogenetics: a. Genetic polymorphism in Drug metabolism: Cytochrome P-450 Isoenzymes. b. Genetic Polymorphism in Drug Transport and Drug Targets. c. Pharmacogenetics and Pharmacokinetics / Pharmacodynamic considerations Number of lectures Total number of lectures Recommended Books [1]

04 05

23 45

Central Drugs Standard Control Organization. Good Clinical Practices-Guidelines for Clinical Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health; [2] International Conference on Harmonisation of Technical requirements for registration of Pharmaceuticals for human use. ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice.E6; May 1996. [3] Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indian Council of Medical Research, New Delhi. [4] Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan Green, March 2005, John Wiley and Sons. [5] Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and Haynes. [6] Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs. Second Edition, Jan 2000, Wiley Publications. [7] Goodman & Gilman: JG Hardman, LE Limbard, 10th Edn. 2001,McGraw Hill Publications. [8] karen Baxter ; Stockleys Drug Interaction 7th edition ,2006, pharmaceutical press [9] Chi Jen lee, Lucia H Lee, et.al. , Clinical Trials of Drugs And Biopharmaceutical 1st edition, 1996, CRC Taylor & Francis group broken sound parkway, NW, Suite. [10] David machin et.al. Textbook of clinical trials 1st edition , 2005,Jonh Wiley & sons td ,Chichester, England . [11] Julia Lloyed , Ann Raven, Hand Book Of Clinical Research 2nd edition 2006,Churchill livingstone Edinburgh, London, Tokyo Recommended Journals : Indian Journal of Medical Research Indian Journal of Hospital Pharmacy Indian Journal of Clinical Practice Indian Journal of Pharmacy Practice International Journal of Community Pharmacy Annals of Pharmacotherapy New England Journal of Medicine Lancet International Journal of Pharmacy practice UK Hospital Pharmacist, UK; International Journal of Clinical Practice
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