Syllabus MPH

SWAMI RAMANAND TEERTH MARATHWADA UNIVERSITY,
NANDED
School of Pharmacy
PG Course in Pharmacy (M. Pharmacy)

Credit System (Semester Pattern)
Choice Based Credit System (CBCS)
Teaching & Examination Scheme

&
Course Content
w.e.f.: 2014
2014-2015
Page 1 of 69
Swami Ramanand Teer
Teerth Marathwada University, Nanded
ed
School of Pharmacy
Post Graduatte Course in Pharmacy (M. Pharmacy)
(Semester P
Pattern) (Choice Based Credit System)
Effective from 2014-15
OBJECTIVES
To
o generate Pharmacy Post Graduates with profound knowledge in various branches of
Pharmaceutical Sciences to meet with the rapidly increasing demands put forward by
Pharmaceutical Manufacturing
Pharmaceutical Research & Development
Pharmacological research including preclinical & clinical studies.
Herbal Drug Research
Pharmaceutical & Herbal Drug Analysis
Clinical Toxicology & Toxicological Analysis
Page 2 of 69
Swami Ramanand Teer
ed
School of Pharmacy
(Semester P
Teaching Scheme
M. Pharm. Pharmaceutics
Semester-I
Subject Subject Tiitle Contact Credits
code Hours/Week
L T Tot
ota
MPH-101 Advance Analytical Techniques 3 01 - 4 4
MPH -102 Quality Assurance of Pharmaceutical 3 01 - 4 4
MPHE Products
Elective I 3 01 - 4 4
MPHE Elective - II 3 01 - 4 4
MPH-103 Laboratory course -1 - - 8 4 4
MPH-105 Seminar 1
Total 25
Semester II
Subject Subject Tiitle Contact Hours/Wee
ek Credits
code
L T Totaal
MPH-211 Novel Drug Delivery Systems 3 01 - 4 4
MPH-212 Biopharmaceutics & Pharmacokinetics 3 01 - 4 4
MPHE Elective III 3 01 - 4 4
MPH-213 Advanced Pharmaceutics & Cosmaticology 3 01 - 4 4
MPH-216 Seminar 1
Total 25
Semester-III
Subject code Subject Credits
MPH -311 Synopsis & Presentation 05
MPH-312 Experimental / Research Work 15
MPH-313 End Term Progress & Presentation of Work 05
Total 25
Semester-IV
MPH-411 Seminar (on dissertation 05
MPH-412 Dissertation 12
MPH-413 Viva-voce
voce 08
Total 25
Page 3 of 69
Swami Ramanand Teer
ed
School of Pharmacy
(Semester P
Teaching Scheme
M. Pharm. Pharmaceutical Chemistry
Semester-I
Subject code Subject Tittle Contact Hours/Wee
ek Credit
s
L T Totaal
MPH -102 Quality Assurance of Pharmaceutical Products 3 01 - 4 4
MPHE Elective I 3 01 - 4 4
MPH-105 Seminar 1
Total 24
Semester II
ek Credits
L T Tot
otal
MPH-221 Advanced Organic Chemistry 3 01 - 4 4
MPH-222 Advanced Medicinal Chemistry 3 01 - 4 4
MPH-223 Drug Design 3 01 - 4 4
MPH-226 Seminar 1
Total 25
Semester-III
Total 25
Semester-IV
MPH-423 Viva-voce
voce 08
Total 25
Page 4 of 69
Swami Ramanand Teer
ed
School of Pharmacy
ost Graduatee Course in Pharmacy (M. Pharmacy)
Semester Paattern) (Choice Based Credit System)
Teaching Scheme
M. Pharm. Quality Assurance
Semester-I
ek Credits
L T Tot
otal
MPH-105 Seminar 1
Total 25
Semester II
ek Credits
L T Tot
otal
MPH-231 Pharmaceutical Validation 3 01 - 4 4
MPH-232 Product development 3 01 - 4 4
MPH-233 Quality Management 3 01 - 4 4
MPH-236 Seminar 1
Total 25
Semester-III
Total 25
Semester-IV
MPH-433 Viva-voce
voce 08
Total 25
Page 5 of 69
Swami Ramanand Teer
ed
School of Pharmacy
Semester Paattern) (Choice Based Credit System)
Teaching Scheme
M. Pharm. Pharmacology
Semester-I
ek Credits
L T Totaal
MPH-103 Laboratory course -1 - - 8 4
MPH-105 Seminar 1
Total 25
Semester II
ek Credits
L T Tot
otal
MPH-241 Molecular Pharmacology 3 01 - 4 4
MPH-242 Clinical Pharmacokinetics 3 01 - 4 4
MPH-243 Pharmacological Screening Methods 3 01 - 4 4
MPH-246 Seminar 1
Total 25
Semester-III
Total 25
Semester-IV
MPH-443 Viva-voce
voce 08
Total 25
Page 6 of 69
Swami Ramanand Teerth Marathwada University, Vishnupuri, Nanded
N
Post Graduatee Course in Pharmacy (M. Pharmacy)
Credit System (Semeester Pattern) (Choice Based Credit System)
Efffective from October 2014
List of EElective Courses/Subjects
Semester-I
MPHE-101: Research Methodologogy & Biostatistics

MPHE-102: Drug Regulatory Affaairs
MPHE-103: Pharmacovigilance & Pharmacoepidemiology
MPHE-104: Drug Metabolites
MPHE-105: Pharmacoinformaticcs
Semester-II
MPHE-206: Industrial Pharmacy

MPHE-207: Natural Products
MPHE-208: Biological Evaluation
MPHE-209
209 Clinical Pharmacology & Toxicology
MPHE-210 Pharmaceuticals Stab bility Studies
MPHE-211 Quality Assurance Apppproach and Improvement
MPHE-212: Sterile Products Formmulation & Technology
MPHE-213: Biomaterials for Drug
ug Delivery
MPHE-214 Polymers in Pharmacceutics
I & II Semester
Full Marks for each theory course: 100
Full marks for each lab course: 100
Full Marks for seminar:
25
IIIrd Semester 125
Full marks for Synopsis and PPresentation: 375
Full marks for Experimental //Research Work:
Full marks for End term progrress and Presentation of Work: 125
IVth Semester
Full Marks for Seminar on Dissertation: 125
Full Marks for Dissertation 300
Full Marks for Viva-voce
voce 200
Page 7 of 69
Swami Ramanand Teer
ed
School of Pharmacy
(Semester P
Examination Scheme
Theory Course
Continuous Internal Assessment (CIA) End Semester Total

Assessment (ESA) Marks for
Unit Test 1 Unit Test 2 Home Max Marks Duration Max Subject
Duration Max Duration Max Assignme (Hr) Marks
(Hr) Marks (Hr) Marks nt
01 15 01 15 20 50 02 50 100
Lab Course
Continuous Internal Assessment (CIA) End Semester Total

Assessment (ESA) Marks
Unit Test 1 Unit Test 2 Record Book Max Duration Max for
Duration Max Duration Max / Viva voce Marks (Hr) Marks Subject
(Hr) Marks (Hr) Marks
08 20 08 20 10 50 06 50 100
Page 8 of 69
Swami Ramanand
d Teerth Marathwada University, Nanded
M.Pharm. Syllabus
M
M. Pharm. (Semester I)
Pharmaceutics/Pharmaceutical
ical Chemistry/Pharmacology/
Chemistry/Pharmacology/Quality Ass
ssurance
(Compullsory & Common Subject)
Subject code: MPH-101
Subject : Advanced Analyttical Techniques (TH) ( Credits)
(4
----------------------------------------------------------------------------------------------------------------------
1 Spectroscopic methods: Theory, Instrumentation, chemical applications and structural elucidation
by UV, IR, FTIR, NMR, C13 NMR, Mass Spectrometry, ESR and Emission spectroscopy. (25 hrs)
2. Separation Techniques: Fundamental principles, theory, instrumentation and applications of Gas

Gas-
liquid chromatography, HPLC, Gel chromatography, GC
GC-MS, HPTLC, and d Ion Pair Chromatography.
(15 hrs)
3. Thermal Analysis: Theory, Instrumentation and applications of Thermogravimetric Analysis (TGA)

and Differential Thermal Analysis (DTA). (5 hrs)
4. Home Assignment
Immunochemical Techniques: Immunoelectrophoresis,

s, Immunoprecipitation, ELISA,
Radioimmunoassay.
References:
(1) Theory and applications of ultraviolet spectroscopy M. Orchin and H. H. Jaffe, John Wiley and
Sons, N. Y.
(2) Spectrometric identification of organic compounds Silverstein, Basseler, Morril, John Wiley and
Sons, N. Y.
(3) Instrumental Methods of Analysis
Analysis Willard, Merritt, Dean, CBS-Publishers
Publishers and Distributors, Delhi
(4) Applications of Absorption Spectroscopy of Organic Compounds J. R. Dyer, Prentice Hall, London
(5) Chemical Applications of Infra--red spectroscopy C. N. R. Rao., Academic Press, N. Y.
(6) Applications of NMR spectroscopy in organic chemistry L. M. Jackmann and B. D. Sternhell,
Pergamon Press, London
(7) Interpretation of Mass Spectra. F. W. McLafferry
(8) Introduction to High Performance Liquid Chromatography R. J. Hamilton, Chapman and Hall,
London
(9) Pharmaceutical Analysis Modern Methods
Methods-Part A and Part B J. W. Munson, Marcel and Dekker
(10) Indian Pharmacopoeia-2007
(11) Martindale: The complete
plete Drug Reference 2007
(12) Impurities Evaluation of Pharmaceuticals
Pharmaceuticals- Satinder Ahuja
(13) Modern Instrumental Analysis, Vol 47(Comprehensive Analytical Chemistry) - Satinder Ahuja , Neil
Jespessen
(14) Practical HPLC Method Development, 2nd Edition- Lloyd loyd R. Snyder, Joseph J. Kirkland, Joseph L.
Glajch
Page 9 of 69
Swami Ramanand d Teerth Marathwada University, Nanded
M.Pharm. Syllabus
Pharmaceutics/Pharmaceutical ical Chemistry/Pharmacology/
Chemistry/Pharmacology/Quality Assurance
(Compulsory ry & Common Subject)
Subject : Quality Assurance of Pharmaceutical Products (QAPP) ( Credits)
(4
----------------------------------------------------------------------------------------------------------------------
1. Good manufacturing practices

practices:: GMP in manufacturing processing and quality control of drugs,
control of facility, personal, productio
productionn and process controls, packaging and labeling controls,
documents, WHO GMP guidelines. GMP for ayurvedic products, Good clinical practice (GCP), Good
laboratory practice (GLP), Good Pharmacy practice (GPP) (10 hrs)
2. Validation: Pharmaceutical process validation, equipment validation and sterile products validation.
(10 hrs)
3. Quality control of pharmaceutical dosage forms: Solid and semi-solid

solid dosage forms, disperse
systems and parenteral dosage forms. (8 hrs)
4. ICH Stability Guidelines (3 hrs)
5. Schedule M and Schedule Y (14 hrs)
6. Home Assignment
1. Preparation of Validation Protocol for different dosage form and preparation of SOP for
Laboratory Instruments / Equipments.
2. The Indian Patent Act 1970 and Amendments.
References:
(1) Automation and Validation of information in Pha Pharmaceutical Processing J. F. Despautz,Marcel and
Dekker
(2) Validation of aseptic pharmaceutical processing F. J. Carleton and J. P. Agalloco, Agalloc Marcel and
Dekker
(3) Pharmaceutical process validation J. R. Berry and R. A. Nash, Marcel and Dekker
(4) Good Manufacturing Practices for pharmaceuticals S. H. Will and J. R. Stoker,Marcel Stoker, and
Dekker
(5) Design of Experiments for process improvement and qua quality Assurance R. F. Brewer
(6) Law and drug S. S. N. Katju, Law of publication (I) Pvt Ltd
(7) Encyclopedia of pharmaceutical technology, Marcel and Dekker
(8) Achieving sterility in medical and pharmaceutical products N.A.Halls, Marcel andDekker
Page 10 of 69
M.Pharm. Syllabus
Subject : Laboratory Course I ( Credits)
(4
----------------------------------------------------------------------------------------------------------------------
1. Combination Drug Analysis (any two)
Vitamins, Sulphas, Analysis of Antipyretics and Analgesics, Steroidal anti-inflammatory

inflammatory drugs,
Antihistamins.
2. Illustrations of theoretical principles using assay of drugs form in various pharmacopoeias (any
five).
This should cover titrimetric, gravimetric, spectro

spectro-photometric
photometric (including flame photometric)
methods.
hods. HPLC etc. The titrimetric methods should include agrentometric, conductometric,
potentiometric end point determination. The students should be exposed to handling of as many
instruments as possible by themselves or under the guidance of a teacher.
3. Interpretation of UV, IR, NMR, C13 NMR spectra and Mass Spectroscopy of some chemicals and
drugs. (minimum three combined spectra).
4. Preparation of research proposal for a specific problem and assessment (any two).
References:
(1) Pharmaceutical Analysis Modern methods Part A and Part B J. W. Munson, Marcel Dekker
(2) Quantitative Analysis of Drugs in Pharmaceutical formulations P. D. Sethi, VBS Publishers, Delhi
(3) Pharmacopoeia of India.
(4) Practical Pharmaceutical Chemistry,
emistry, Part I and Part II A. H. Beckett, J. B. Stenlake, CBS Publishers,
Delhi
(5) Colorimetric Methods of Analysis F. D. Snell and C. T. Snell, Van Nostrand Reinhold Company, N. Y.
(6) Chemical Applications of Infrared spectroscopy C. N. R. Rao,, Academic Press N. Y.
(7) Applications of Absorption Spectroscopy of Organic Compound J. R. Dyer, Prentice Hall Englewood
Page 11 of 69
M.Pharm. Syllabus
Subject : Laboratory Course 2 ( Credits)
(4
----------------------------------------------------------------------------------------------------------------------
Experiments based on following concepts:
1. Validation of equipments: Autoclave, hot air oven, membrane filter (Minimum two practical).
2. Validation of an analytical method: Calibration of instruments as per official procedure (UV,FTIR,

Conductivity meter, flourimeter,
ourimeter, Digital pH meter, Digital balance, Potentiometer, HPLC, Gas
chromatography) (Minimum two practical).
3. Quality
ality control of pharmaceutical dosage forms: Tablets, Capsules, Liquid oral, Parenteral,
External preparation (minimum eight practical).
References:
(1) Pharmaceutical Analysis Modern methods Part A and Part B J. W. Munson, Marcel Dekker
(2) Quantitative Analysis of Drugs in Pharmaceutical formulations P. D. Sethi, VBS Publishers, Delhi
(3) Pharmacopoeia of India.
(4) Practical Pharmaceutical Chemistry, Part I and Part II A. H. Beckett, J. B. Stenlake, CBS Publishers,
Delhi
(5) Colorimetric
metric Methods of Analysis F. D. Snell and C. T. Snell, Van Nostrand Reinhold Company, N. Y.
(6) Chemical Applications of Infrared spectroscopy C. N. R. Rao, Academic Press N. Y.
(7) Applications of Absorption Spectroscopy of Organic Compound J. R. Dyer, Prentice Hall Englewood
Page 12 of 69
Swami Ramanandd Teerth Marathwada University, Nanded
M.Pharm. Syllabus
M
Chemistry/Pharmacology/Quality Assurance A
(Elective)
Subject code: MPHE-101
Subject : Research Meth thodology and Biostatistics (TH) (4
4 Credits)
-----------------------------------------------------------------------------------------------------
I. Research:
1. Meaning of research, purpose of research and types of research (clinical experimental, basic,
applied and patent and oriented research) objects of research (4 hrs).
2. Literature survey:
Using library, book and journals, MEDLINE
MEDLINE- internet getting patents nts and reprints of articles as
sources for literature survey. (2 hrs)
3. Selecting a problem and preparing a research proposa
proposall for different types of research
sources of procurements of grants. (2 hr)
4. Documentation: (4 hrs)
Importance of documentation in case of research record and GMP/GLC
Techniques of documentation in case of research record and GMP and GLC
Uses of computer uter packages in clinical trials
Documentation in clinical trails
5. Research report/paper writing/thesis writing / poster presentation: (10 hrs)
l Different parts of research report or paper
l Title-title
title of project with authors name
l Abstract-statement
statement of the problem, background list in brief, purpose and scope
l Key words
l Methodology-subject,
subject, apparatus/instrumentation and procedure
l Results-tables,
tables, graphs, figures and statistical presentation
l Discussion-support
support or non
non-support to hypothesis.sis. Practical and theoretical implications
l Acknowledgements
l References
l Errata
l Importance of spell check
l Use of foot notes
II. Methodss and tools used in research: (5 hrs)
l Research design (futures of good design, types of research designs, basic p principles of
experimental design).
l Qualitative studies, quantitative studies.
l Simple data organization, descriptive data organization.
l Limitations and sources of errors.
l Enquiries in forms of questionnaire, opinionnaire and interviews
III. Presentation: (5 hrs)

l Importance, types, different skills
l Content of presentation format of model, introduction and endings.
Page 13 of 69
l Posture, gesture, eye contact, facial expression, stage fright.
l Volume, pitch, speed, pauses and languages
l Visual aids and seating arrangements
l Question and answer session
IV. Cost Analysis of Projects and Clinical Trials (3 hrs)

V. Biostatistics ( 10 hrs )
l Statistical analysis of data including variance, standard deviation, students t test and
ANOVA, co relation of data and its iinterpretation, computer data analysis, bio statistics for
clinical trials.
l Scientific method in medicine
l Scientific equations of therapy
VI. Home Assignment

1. Industrial
ndustrial institute interaction
2. Industrial projects their feasibility reports.
3. Funds in research
4. GATT trips
References:
(1) Research in education John W. Best Jems V. Kahn

(2) Research methodology C. R. Kothari
(3) Methodology and techniques of social research Willkinson and Bhandarkar
(4) Presentation skills Michel Halton Indian society for institute education
(5) Practical introduction to copyrights Gavin Mofariane
(6) Thesis projects in sciences and engineering Richard M. Devis
(7) Scientist in legal system Ann Labor Science
(8) Thesis and assessment writing Janolthon Anderson
(9) Writing a technical paper Donald Manzel
(10)Effective business report writing Lel and Brown
(11)Protection of industrial property rights Purshottam Das and Gokul Das
(12)Spelling for millions Edna Furmess
(13)Preparation for publications King Edwards hospital foundation for London
(14)Information technology The hindu speeks
(15)Documentation genesis and development 3792.
(16)Ayurveda and modern medicine R. D. Lele
(17)How to write and publish a scientific paper Robert A. Day Cambridge
University Press 4th edition 1994
(18)Lecture notes on patent TIFAC: DOC: 022, TIFAC July 2002.

(19)Introduction to Statistical Methods
Methods- C. B. Gupta
(20)A first course in Mathematical Statistics
Statistics- C. E. Weatherborn
(21)Introduction to Biostatistics-Mahajan
Mahajan
Page 14 of 69
M.Pharm. Syllabus
M
(Elective)
Subject : Drug Regulatory Affairs (DRA) (TH) (4
4 Credits)
-----------------------------------------------------------------------------------------------------
1. Aims, objects and salient features of following legislations affecting
pharmaceutical industry. (5 hrs)
l Industrial Development and Regulation Act 1951.
l Consumer Protection Act.
2. Australian TGA guidelines (2 hrs)

3. US-FDA, CDER guidelines (5 hrs)
4. New Drug Application (4 hrs)
5. Pollution and Environmental Control Act (3 hrs)
6. Drug Master File (3 hrs)
7. Intellectual Property Rights: (10 hrs)
l Protection of patients and trademarks and design and copy rights and patent system in India.
l Present status of IPR future changes expected in Indian patents.
l What may be patented
l Who may apply for patent
l Preparation of patent proposal
l Registration of patent in India and foreign countries and vice versa
l ICH guidelines for clinical trials, therapeutic drugs monitoring drugs and bioequivalence.
l Exclusive marketing rights
l Black box
l IPR and IDMA views on patents
l Human health and patent laws latent lethality
l Indian patent act and copyright (Indian act)
8. Drug and Cosmetics Act 1940 (8 hrs)
9. Prevention of Food Adulteration Act 19 1954 (5 hrs)
10. Home Assignment
1. Preparation of DMF, Site Master File, Master Formula Record.
2. Procedure for filing of Patent.
Reference:
(1) Guidelines of various countries like MCA, TGA, ICH.
(2) Drug and cosmetic act 1940 and rules their under
(3) IPR Lecture notes
(4) GLP regulation by Alen Hirsch Vol 38 Marcel Decker series
(5) GMP for pharmaceuticals forth edition by S. Willing, J. Stocker Marcel Decker series 1997.
(6) I.P., B.P., U.S.P. International Pharmacopoeia
(7) Pharmacokinetics, Regulatory, Industrial, academic prospe
prospective
ctive by P. G. Willing and F.T.S. Tse.
Page 15 of 69
M.Pharm. Syllabus
M
(Elective)
Subject : Pharmacovigilaance & Pharmacoepidemiology (TH) (4 Credits)
---------------------------------------------------------------------------------------------------
1: Introduction to Pharmacovigillance:
Introduction, Definition, requirem
ment of Pharmacovigilance needed, Objeectives of
Pharmacovigilance, Agencies cooncerned with Pharmacovigilance, Reportiing ADRs,
and changes to recommendations for use, Methods involveed in
Pharmacovigilance, Pharmacovigilaance plans, Scope of Pharmacovigilance, Indiaan scenario,
Pharmacovigilance and pharmacogeenomics
2: Safety monitoring process & goo

good Pharmacovigilance Practices (GPP):
The Monitoring Process, The R Role of Institutional Review Boards and Data
D Safety
Monitoring Boards, Quality Assuurance Monitoring, Ending Trials Early: Prootecting the
Interests of Participants and the P
Public.GPP, Overview of Risk Management Goals and
Guidance, Adverse events, se serious adverse events, Reporting of AE E & SAE,
Pharmacovigilance
3: Good reporting practices and ssafety signals:

Risk management process, Signaals, Case report, Case series, Causality, Data
D mining,
reporting rates Vs incideence rates, Pharmacovigilance plans, Pharmaco-
epidemiologic safety studies
4: Pharmacoepidemiology, Registters, Surveys:

Pharmacoepidemiology, Guidelinees for Good Pharmacoepidemiology Practicces (GPP),
Pharmacovigilance Methods, Use of health care databbases in
pharmacoepidemiology, Registtries, Surveys, Pharmacoeconomics anda
pharmacoepidemiology, Pharm
macoepidemiology and pharmacokinetiics,
International drug monitoring, Using eHealth information for compreehensive
Pharmacovigilance surveillance, Pharmacoepidemiology in India,
Pharmacovigilance and India
References:
1. Textbook of therapeutics Drrug and Disease Management: Eric T Herfinde

del, Dick R.
Gourley, 6th ed.
2. Assuring Data Quality And Validity In Clinical Trials For Regulatorry Decision
Making: Janet Woodcock, ck, Frederick Ognibene, John Overbeke.20 2003; Welly
Publication.
3. Medical Transcription Guiide: Do's and Don'ts (Medical Transcriptioon Guide):
Marilyn Takahashi Fordneyy, Marcy Otis Diehl.
Page 16 of 69
Page 17 of 69
M.Pharm. Syllabus
M
(Elective)
Subject : Drug Metabolittes (TH) (4
4 Credits)
---------------------------------------------------------------------------------------------------
1. Review of drugs metabolism & metabolites. Importance in drug design and discovery,
use of software/ study of currennt available software
2. Chemical changes / biochemicaal changes takes place while drugs metabolism along with
chemistry of metabolites.
3. Introduction to metabolite identtification in body (urine, serum, organs etc)
a. Various analytical techniqu
ques to identify metabolites
b. Chromatography (HPLC,, GC), spectroscopic (NMR, MS)
c. Hyphenated (LC-MS, GC C-MS) Tandem (MS-MS)
d. Emerging- proteomics, M Metabolomic etc
4. Metabolites in disease conditionns
Overview of occurrence off drugs / endogenous metabolite during following
disease/disorder conditions alonng with their physiological/pathological role-
a. Diabetes mellitus
b. Cancer
c. Epilepsy
d. Infectious conditions likke bacterial, fungal & viral
e. Cardiovascular disorderrs
f. Pregnancy, lactation likee special conditions
g. Endogenous metabolitess and diseased condition
I. Vitamins (Vitt D cancer, bone health; Vit E-atherosclerosis,, etc)
II. Enzymes
III. Hormones
5. Metabolites of imp categoryy of drugs related to above mentioned conditionss
6. Metabolites of important ph phytochemicals like papavarine, nicotine, taxol, isoflavones,
omega 3 fatty acids etc
7. Guidelines for Safety Testingg of Drug Metabolites
8. Effect of modification of drugs
ugs formulation on occurrence/formation of mettabolites
9. Age and genetic related varriation in formation of drugs metabolites and its clinical
significance.
Page 18 of 69
References:
1. Metabolomic in Practice: Succ ccessful Strategies to Generate and Analyze .... edited
by Michael Lmmerhofer, Wolf lfram Weckwerth
2. Guidance for Industry Safetyy Testing of Drug Metabolites U.S. Deparrtment of
Health and Human Services Food and Drug Administration Center for f Drug
Evaluation and Research (CDE ER) February 2008 Pharmacology and Toxicoloogy
3. Guidance for Industry Safetyy Testing of Drug Metabolites U.S. Deparrtment of
Health and Human Servicess Food and Drug Administration Center for f Drug
Evaluation and Research (CDE ER) February 2008 Pharmacology and Toxicoloogy
4. Identification and Quantificatiion of Drugs, Metabolites and Metabolizing Enzymes
by LC-MS Edited by Swappan Choudhary Hardbound, 354 Pages Published: P
November 2005 ISBN 13: 978--0-444-51710-4
5. High Throughput Bioanaalytical Sample Preparation By Daviid
Wells Hardbound, 640 Pages Published: January 2003 ISBN 13: 978--0-444-
51029-7
6. Biotransformation and Metaabolite Elucidation of Xenobiotics: Charactterization
and Identification Ala F. Naassar (Editor) ISBN: 978-0-470-50478-9 328 pages
November 2010 Copyright 2000-2014 by John Wiley & Sons, Inc., or o related
companies. All rights reserved.
d.
7. Reactive Drug Metabolites, Volume 55, Amit Kalgutkar, Deepak Dalvie, D R.
Scott Obach, Douglas A. Smitth, Raimund Mannhold (Series Editor), Hugo Kubinyi
(Series Editor), Gerd Folkers (S(Series Editor) ISBN: 978-3-527-33085-0, 402 pages,
October 2012, Copyright 2000 2000-2014 by John Wiley & Sons, Inc., or o related
companies. All rights reserved.
d.
8. Mass Spectral and GC Dataa of Drugs, Poisons, Pesticides, Pollutants and
Their Metabolites, 4th Edition Hans H. Maurer, Karl Pfleger, Armin A. Webber ISBN:
978-3-527-32992-2 1642 pagess August 2011 Copyright 2000-2014 by John hn Wiley
& Sons, Inc., or related compannies. All rights reserved.
9. Metabolome Analysis: An Introduction Silas G. Villas-Boas, Jens Nielsen,
Jorn Smedsgaard, Michael A.. E. Hansen, Ute Roessner-Tunali ISBN: 978-0-471-
978
74344-6 319 pages February 2007 Copyright 2000-2014 by John Wiley & Sons,
Inc., or related companies. All
ll rights reserved.
10. All related reference books/ jouurnal articles under Pharmacology, Medicinal
Chemistry, Pharmaceutical Anaalysis, Pharmacognosy & Phytochemistry etc.
Page 19 of 69
M.Pharm. Syllabus
M
Pharmaceutics/Pharmaceutical
ical Chemistry/Pharmacology/
A
(Elective)
Subject : Pharmacoinformatics (TH) (4
4 Credits)
1. Chemoinformatics: Introdu duction, molecular structures, representatiion and
manipulation of 2D and 3D structures, generation of 3D structures visuualization
techniques, molecular databasses, virtual screening, chemical libraries, molecular
m
descriptors, calculation of descriptors reflecting physical and chemical
properties of molecules, moolecular similarities and complementarities, selection
of structurally diverse and representative sets, molecular properties, solubility
s
partition coefficient, drug likee properties, data analysis, quantitative and qualitative
q
structure activity relationship,
p, prediction of ADME properties, applica cation of
Chemoinformatics in drug reseaearch.
2. Programming in C, C++, charac acter manipulation, programming techniques foor data
base management and developiing database oracle.
3. Programming in database environment, development of databases, relational r
databases, information retrieeval systems, general search methods, Meeans-ends
analysis, depth first search, brreath first search, optimal search, branch annd bound
etc. Oracle database environm ment.
4. Web based search engines and the details of their search algorithms especiallyy
pertaining to bio-computing.
5. Molecular modeling : Energy minimization, geometry optiimization,
conformational analysis, global conformational minima determ
mination,
approaches and problems, bioactive vs. global minimum confoormations,
automated methods of connformational search, advantages and limitaations of
available software, molecular graphics, computer methodologies behind molecular
m
modeling including artificial inte
telligence methods.
6. Structure activity relationshhips in drug design: qualitative vs. quantitative
qu
approaches, advantages andd disadvantages, random screening, noonrandom
screening, drug metabolism studies, clinical observations, rational app pproaches
to lead discovery, homologattion, chain branching, ring chain transformatiions, bio-
isosterism, insights into moleccular recognition phenomenon, structure based drug
design, ligand based drug dessign.
7. QSAR: Electronic effects, Ham mmett equations, lipophilicity effects, Hanschh equation,
steric effects, Taft equation, exxperimental and theoretical approaches for deetermination of
physicochemical parameters, parameter inter-dependence, case studies, reggression
analysis, extrapolation vs. innterpolation, linearity vs. non linearity, impportance of
biological data in the correct foorm, 3D-QSAR example CoMFA and CoMSIA A
Page 20 of 69
References:
Westhead, D.R, Parish, J.H. and T Twyman, R. M., Instant notes in bio informaticcs, BIOS
scientific publishers, 2002. (ISBN.
N. 1859962726)
Attwood, T.K. and parry-smith, D.J.,
D Introduction to bioinformatics, Addison-W
Wesney-
Longman Ltd. 1999 (ISBN 0582327881)
Baxevanis, A.D. and Ouellette, B.F.F.,
B Bioinformatics; A practical guide to the analysis
of genes and proteins, John Wiley,, 1998 (ISBN 047119196)
Mount, D.W, Bioinformatics: S Sequence and genome analysis, cold springg harbor
laboratory press. (ISBN 0879695978)
087969597
Lesk, A.M., Introduction to bioinfo
formatics, Oxford University press (ISBN 0199251967)
Durbin, R., Eddy, S., Krogh and Mitchison, G., Biological sequence analysis:
Probabilistic models of proteins and nucleic acid, Cambridge university presss, 1998.
(ISBN 0521629713)
Baldi, P. and Brunak, S., Bioinfoormatics: The machine learning approach, MIT,
MI 1998
(ISBN 026202442X.)
Brandon, C.I. and Tooze J., Introdu
duction to protein structure, Garland pub., 1991. (ISBN
0815302703)
Lesk, A.M., Introduction to prottein architecture: The structural biology of proteins,
p
Oxford University press 2001. (IS
SBN 0198504748)
Creighton, T.E., Protein Structture: A practical approach. Irl. Pr., 1997. (ISBN
0199636184)
Schultz, G.E., Principles of protein structure, Springer Verlag, 1978 (ISBN:
0387903348)
Sternberg, M (Ed), Protein structuure prediction- A practical approach, Oxford unniversity
press, London 1996.
Page 21 of 69
SEM
MESTER-II
Page 22 of 69
M
M.Pharm. Syllabus
M. Pharm. (S
Semester II) PHARMACEUTICS
(
(Compulsory Subject)
Subject code: MPH - 211
Subject: Novel Drug Delivery System (NDDS) (4 Credits)
----------------------------------------------------------------------------------------------------------------------
1. SUSTAINED AND CONTROLLED RELEASE DRUG DELIVERY SYSTEMS 14 hours
Introduction; Rationale of SRDDS; Advanta
Advantages
ges and Disadvantages of SRDDS; Factors influencing the
design and performances of SRDDS: A) Physicochemical properties of a drug influencing design and
performance; B) Biological factors influencing design and performance of SRDDS. Different Micro-
Micro
encapsulation processes.
Introduction, Design and Development of oral controlled release drug administration: Dissolution
controlled, Diffusion controlled (Reservoir devices, Matrix devices), Membrane permeation controlled,
Osmotic pressure controlled, Gel diffusion controlled, pH controlled, Ion - exchange controlled delivery
systems.
2. POLYMERS SCIENCE 5 Hours.
Introduction, Polymer-classification,
classification, Applications of Polymers in formulation of controlled drug delivery
systems, Biodegradable and Nonbiodegradable polymers, Properties of following commonly used
polymers- Starch,
h, Gelatin, Chitosan, Albumin, Cellulose derivatives and Poloxamers.
3. TRANSDERMAL DRUG DELIVERY SYSTEMS 6 Hours
Permeation through skin, Factors affecting permeation, Basic components of TDDS, Fo
Formulation
approaches used in development of TDDS and their evaluation, Permeation enhancers.
5. MUCOADHESIVE DRUG DELIVERY SYSTEMS 7 Hours
Introduction, 1) Buccal drug delivery system: Concepts, Ad
Advantages
vantages and Disadvantages, Structure of
oral mucosa, Trans-mucosal
mucosal permeability, Permeability enhancers, in vitro and in vivo methods for
Buccal absorption; 2) Nasal Drug Delivery Systems: Introduction, Physiology of nose, Fundamentals of
nasal absorption,
on, Distribution of drug in the nasal cavity, Enhancement in absorption, in vitro and in vivo
methods for determination of nasal absorption.
6. OCCULAR DRUG DELIVERY SYSTEMS 3 Hours

Formulation and evaluation of occular controlled drug delivery systems, ophthalmic inserts and in situ
gels.
7. TARGETED DRUG DELIVERY SYSTEMS 10 Hours
Page 23 of 69
Concepts, Advantages
vantages and Disadvantages, Targeting of drugs through nanoparticles, liposomes, resealed
erythrocytes, microspheres, magnetic microspheres, monoclonal antibodies, pulsatile drug delivery.
Study on colon targeting. Biosome.
HOME ASSIGNMENT:
Protein & Peptide
de Drug Delivery System
Physical aspects, biochemistry of protein drug (structure, properties & stability), barrier to transport &
pharmacokinetics,, different routes of delivery.
Intrauterine Drug Delivery Systems
Development of intrauterine devices
vices (IUDs), copper IUDs, hormone-releasing IUDs.
REFERENCE BOOKS:
1. Encyclopedia of controlled delivery; By Edith Mathiowitz, Published by Wiley Interscience Publication,
John Wiley and sons, Inc, New York / Ch
Chichester / Weinheim.
2. Controlled and Novel Drug Delivery; By N.K.Jain, CBS Publishers and Distributors, New Delhi, First
edition, 1997 (reprint in 2001).
3. Controlled Drug Delivery - Concepts and Advances; By S.P.Vyas and R.K.Khar, Vallabh Prakashan, New
N
Delhi, First edition, 2002.
4. Remingtons Pharmaceutical Sciences.
5. Novel drug delivery system; By Y.M.Chien, Marcel Dekker, Inc.
6. Controlled Drug Delivery - Fundamentals and Applications, 2nd edition; By
Joseph R.Robinson and Vincent H.L.Lee.
7. Pharmaceutical Dosage forms, disperse system: Volume 1, By Herbert A.Libermann et.al, Marcel
Dekker, Inc.
8. Pharmaceutical Dosage forms: Tablets Volume II, Herbert A.Libermann et.al, Marcer Dekker, Inc.
9. Bentleys Textbook of Pharmaceutics; By E.
E.A.Rawline, ELBS Publications.
10. Microencapsulation and Related Drug Process; By Patric B.Deasy.
Page 24 of 69
M
M.Pharm. Syllabus
M. Pharm. (S
(
Subject: t: Biopharmaceutics & Pharmacokinetics (BPPK) (4 Credits)
----------------------------------------------------------------------------------------------------------------------
1. ABSORPTION OF DRUGS 7 Hours
Definition, Structure of cell membrane and composition, Gastrointestinal absorption Mechanism,
Factors affecting drug absorption: Biological, Physiological, Physico
Physico-Chemical
Chemical and Pharmaceutical dosage
form factors; Methods of determining absorption
absorption: In Vitro and In Vivo methods.
2. DISTRIBUTION OF DRUGS 7 Hours
Definition, Distribution in blood and other fluids: cellular distribution, drug penetration to CNS, placental
transfer of drugs and blood flow, Factors affecting drug distribution
distribution,, Volume of distribution,
3. PROTEIN BINDING 3 Hours
Plasma protein binding: factors affecting, significance and kinetics of protein binding
binding.
4. METABOLISM OF DRUGS 5 Hours
Definition, brief overview of Phase se I (Oxidative, reductive and hydrolytic reactions) and Phase II
reactions (Conjugation) of Biotransformation.
Biotransformation Factors affecting biotransformation.
5. EXCRETION OF DRUGS 5 Hours
Definition, Renal and non-renal
renal excretion, Concept of clearance - Renal clearance, Organ clearance &
Hepatic clearance.
6. BASIC CONCEPTS OF PHARMACOKINETICS 14 Hours
Basic considerations, Pharmacokinetic ic models, Compartment modeling: one compartment model - IV
bolus, IV infusion, Extra-vascular;
r; Multi Compartment models; Two compartment model - IV bolus, IV
infusion, Extra-vascular, Three
ree Compartment model in brief.
7. NON-LINEAR
LINEAR PHARMACOKINETICS 4 Hours
Cause of non-linearity, Michaelis-Menten
Menten equation, Estimation of Km and Vmax.
HOME ASSIGNMENT.
Application of Pharmacokinetics in Novel drug delivery systems.
Dosage Regimen
Concept of loading dose & maintenance dose, Multiple dosing with respect to
I.V. and oral route, Adjustment of dosage in renal and hepatic impairment,
Individualization of therapy, Therapeutic Drug Monitoring.
BCS Classification of drugs.
REFERENCE BOOKS:
1. Biopharmaceutics and clinical Pharmacokinetics By Milo Gibaldi.
2. Remingtons Pharmaceutical Sciences; By Mack publishing company, Pennsylvania.
3. Pharmacokinetics; By Milo Gibaldi, Donald Perrier; Marcel Dekker, Inc.
Page 25 of 69
4. Handbook of clinical Pharmacokinetics;
tics; By Milo Gibaldi and Laurie Prescott by ADIS Health Science
Press.
5. Biopharmaceutics and Pharmacokinetics; By Robert E. Notari.
6. Biopharmaceutics; By Swarbrick.
7. Biopharmaceuties and Pharmacokinetics-
Pharmacokinetics A Treatise; By D.M.Brahmankar and Sunil B.Jaiswal.,
B.Ja Vallabh
Prakashan Pitampura, Delhi.
8. Clinical Pharmacokinetics, Concepts and Applications; By Malcolm Rowland and Thomas N.Tozer. Lea
and Febiger, Philadelphia, 1995.
9. Dissolution, Bioavailability and Bioequivalence; By Abdou.H.M., Mack Publis
Publishing
hing Company,
Pennsylvania, 1989.
10. Biopharmaceutics and Clinical Pharmacokinetics
Pharmacokinetics- An introduction; 4th edition, Revised and expanded
By Robert. E. Notari, Marcel Dekker Inc, New York and Basel, 1987.
11. Encyclopedia of Pharmaceutical Technology, Vol 113, 3, James Swarbrick, James. C.Boylan. Marcel
Dekker Inc, New York, 1996.
Page 26 of 69
M
M.Pharm. Syllabus
M. Pharm. (S
(
Subject: Advanced Pharmaceutics & Cosmeticology (4 Credits)
----------------------------------------------------------------------------------------------------------------------
1. STERILIZATION PROCESS 8 Hours
Principle, Advantages, Disadvantages, Applications of different sterilization methods, equipments.
Sterility testing: Principle, general
neral procedure, control tests, sterility testing of some preparations like
parenterals and ophthalmic preparation, ampoules, vials, syringes and needles.
2. STABILITY TESTING 5 Hours
Physicochemical and biological factors affecting stability of drugs, Methods to find out degradation
pathways, Determination of shelf life by accelerated stability testing, Overages.
3. BIOAVAILABILITY AND BIOEQUIVALENCE STU STUDIES 9 Hours
Definition, Objective of bioavailability, Parameters of bioavailability, Determination of AUC. Estimating
absorption rate of drugs; Measurement of bioavailabilitybioavailability- Pharmacokinetic methods and
Pharmacodynamic methods. Drug dissolution rate & bioavailabil
bioavailability. In vitro drug dissolution testing
models. In-vitro in-vivo correlation. Definitions: Bio equivalence, Chemical equivalence, Therapeutic
equivalence, Pharmaceutical equivalence; Testing of bioequivalence of dosage forms.
4. MICROMERITICS AND RHEOLOGY 6 Hours
A detailed account of micromeritics and rheology including apparatus involved in this area and their
application in pharmacy.
5. PARENTERAL CONTROLLED RELEASE DRUG DELIVERY SYSTEMS
7 Hours
Approaches for injectable controlled release formulations, Development of Injectable controlled -
Release formulations; Approaches
oaches and applications of Implantable Drug Delivery Systems.
6. MANUFACTURING TECHNIQUES AND EVALUATION OF COSMETICS 10 Hours
Manufacturing of Cosmetics like creams, powders, compacts, shampoo, lipstick liquids, ids, foam, aerosol
cosmetics and their Performance, physicochemical and microbiological evaluation. evaluation Design and
Assessment of preservative systems for cosmetics, valuation of preservatives in cosmetic products and
factors affecting activity of preservatives.
HOME ASSIGNMENT:
Packaging Of Pharmaceuticals
Desirable features and a detailed study of different types of Pharmaceutical containers and
closures (Glass, Plastics and Rubber), including their merits and demerits; selection and
evaluation of Pharmaceutical packaging materials.
Importance and status of herbal medicines and cosmetics.
REFERENCE BOOKS:
1. Theory and Practice of Industrial Pharmacy By Lachmann and Libermann.
2. Modern Pharmaceutics; By Gillbert and S. Banker.
Page 27 of 69
4. Advances in Pharmaceutical Sciences Vol. 11-5; By H.S. Bean & A.H. Beckett.
5. Physical Pharmacy; By Alfred martin
6. Bentleys Textbook of Pharmaceutics Rawbins.
7. Pharmaceutical Preformulations; By J.J. Wells.
8. Harrys Cosmeticology.
9. Textbook of Cosmeticology by B.M.Mittial.
10. Textbook of Cosmeticology by P.P.Sharma.
Page 28 of 69
M
M.Pharm. Syllabus
M. Pharm. (S
(
Subject: Laboratory Course 3 08 hr / wk (4 Credits)
-----------------------------------------------------------------------------------------------------------------------
1. Preparation and evaluation of microcapsules/micro spheres by different techniques.
2. Study on diffusion of drugs through various po polymer membranes.
3. Study on In-vitro
vitro dissolution of various sustained release formulations of
marketed products.
4. Preparation of matrix tablets using various polymers, like polyvinyl alcoh
alcohol,
polyvinyl pyrrolidone etc., and studying their release patterns.
5. Preparation of various polymer films, loading of drugs and studying the release Pattern.
6. Film coating
ating of drug pellets for granules with sodium CMC and the study on In Vitro dissolution.
7. Preparation and evaluation of following drug delivery systems:
a. Fast dissolving tablets
b. Gels
8. Preparation of various drug formulations by solid d dispersion
ispersion technique and their evaluation.
(Minimum Two Practical)
9. Formulations based on the cosmetics like vanishing cream, talcum powder, tooth paste, coconut oil
shampoo, paste depilatory,
pilatory, nail polish, lipstick etc.
(Minimum Three Practical)
10.Other formulations based on the theory topics.
RECOMMENDED BOOKS:
All books mentioned as reference books for theory should be used
Page 29 of 69
Swami Ramanannd Teerth Marathwada University, Nanded
M
M.Pharm. Syllabus
M. Pharm. (S
(
Subject: Laboratory Course 4 08 hr / wk (4 Credits)
-----------------------------------------------------------------------------------------------------------------------
1. Pre-formulation
formulation study of tablets.
2. Studying the stability of suspensions using the data on sedimentation volume and degree of
flocculation.
3. Determinations of flow properties of powders by Angle of repose aand flow through an orifice with,
and without glidants. (Minimum Two Practical)
4. Comparison of dissolution studies of two different marketed products.
5. Calculation ka, ke, t1/2, Cmax, Tmax.
6. Calculation of AUC and bioequivalence from the given data for two drugs.
7. In vitro absorption studies.
8. To study the pharmacokinetics of suitable drug after oral administration. (Minimum Two Practical)
9. Extent of plasma-protein
protein binding studies on the same drug (i.e. highly and poorly protein bound drug
)at different concentrations.
10. Accelerated stability study
11. Experiment based on the theory toptopics.
RECOMMENDED BOOKS:
All books mentioned as reference books for theory should be used.
Page 30 of 69
Swami Ramanand
d Teerth Marathwada University, Nanded
M
M.Pharm. Syllabus
M. Pharm. (Semester II) PHARMACEUTICAL
ACEUTICAL CHEMISTRY
(
Subject: t: Advanced Organic Chemistry (4 Credits)
-----------------------------------------------------------------------------------------------------------------------
1. STEREOCHEMISTRY 12 hrs
Molecular dissymmetry, compounds with one, two or more unequal asymmetric carbon atoms and
recimic modifications, configuration absolute and relative, synthesis of optically activ
active compounds,
conformations in cyclic compounds, optical isomerism, shapes of cyclohexanes and six six-membered
heterocyclic rings, shapes of rings other than six membered. Stereoselective synthesis, role of inductive,
resonance and steric effects in structure and relativity.
2. MECHANISM STEREOCHEMISTRY AND APPLICATIONS OF 12 hrs
Birch reduction, Clemensen reduction, Meerwein
Meerwein-Pondroff
Pondroff reduction, Oppennauer oxidation, Wolf
Kishner reduction, Witting Reaction, Pinacol and related rearrangements, Beckmann rearrangement,
Hoffman rearrangement, Claisen rearrangement, Schmidt, Lossen and Curtius rearrangement.
3. PERICYCLIC REACTIONS 8 hrs
Basic theory, orbital symmetry rules and their applications, mechanism, types of pericyclic reactions
reactions-
cycloaddition, electrolytic reaction, and sigmatrophic rearrangement
4. PHOTOCHEMICAL REACTIONS 7 hrs
Introductions and basic principles, photochemistry of carbonyl compounds, photo rearrangements,
photochemistry of alkenes and dienes.
5. SYNTHON APPROACH 6 hrs
a. Definition of terms- disconnection, synthon, functional group interconversions.
b. Basic rules in disconnection.
c. Use of synthon approach in synthesis of following components:
Trimethoprim, Ibuprofen, Propranolol, Piroxicam.
HOME ASSIGNMENT
v Green Chemistry
v Allylic bromination, ozonolysis, free radical reactions, use of diazomethane and peracids in
synthesis
v Study of some reduction of synthetic importance:
Reduction with metallic hydroxides, hydrogenation..
REFERENCES
1. Advanced Organic chemistry, Reaction mechanisms and structure, J. March, John Wiley and
Sons, N.Y.
2. Mechanism and structures
uctures in Organic chemistry, E.S Gold, Hold Richard and
Winstone, New York.
3. The Organic chemistry of Drug Design and Action, R.B. Silverman, Academic
Page 31 of 69
press In., San Diego, 1992.
4. Asymmetrical Synthesis, R.A Aitkin and S.M. Kilengi, Ed., Blackie Academic
and professional London, 1995.
5. Organic chemistry, Clayden, Greeves, Warren and Woihers., Oxford University press 2001.
6. Organic chemistry, Vol I and II. I. L. Finar. ELBUS, Sixth ed., 1995.
7. A guide to mechanisms in Organic chemistry
chemistry- Peterskyes Orient Longman, New Delhi.
8. Reactive intermediates in Organic chemistry
chemistry- Tandom and Gowel.
9. Molecular reaction and photochemistry
photochemistry- C.H. Deupuy and O.L. Chapman
10. Drug stereochemistry Wainer Stering 1st Edn. 1996 Marcel Decker.
11. Photochemistry and Pericyclic reactions, Jagdamba Singh, Jaya Singh, 2nd edition, New edge
International Publishers.
12. Reaction Mechanism In Organic Chemistry, S. M. Mukherji, S.P.Singh, 3rd
edition, Macmillan India Ltd.
13. Comprehensive book of stereochemistry
stereochemistry- by Eliel
14. Text Book of Organic chemistry by Morrison and Boyd
15. Text Book of Organic chemistry by S. K. Ghosh
Page 32 of 69
M
M.Pharm. Syllabus
ACEUTICAL CHEMISTRY
(
Subject: t: Advanced Medicinal Chemistry (4 Credits)
-----------------------------------------------------------------------------------------------------------------------
1. MEDICINAL CHEMISTRY OF 12 hrs
a. Antiviral Agents and agents under development of HIV infection.

b. Immunosuppressant and Immunostimulants.
c. Agents used in Neurodegenerative disease Like Alzheimers and Parkinsonism.
d. GABAnergic Agonists.
2. GASTRIC PROTON PUMP INHIBITORS 5 hrs
Introduction, Gastric acid secretion and its inhibitors, test assay for studying gastric acid inhibitors,
irreversible gastric proton pump inhibitors
3. PROTEINS AND PEPTIDE DRUGS 6 hrs
Chemistry, structure and stability, Reactivity of proteins and peptides. Different ways to synthesize
these Drugs- Study of insulin, Relaxin, Somatostatin, DNAse interferon.
4. COMBINATORIAL CHEMISTRY 8 hrs
a. Introduction
b. Combinatorial approaches
c. Chemical peptide and small molecule libraries
d. Applications, methodology
e. Combinatorial Organic Synthesis
f. Assays and screening of combinatorial libraries
g. Introduction to high Throughputs Screening (HTS)
5. CHIRAL TECHNOLOGY 8 hrs
Introduction to chirality and Techniques used in asymmetric synthesis of
Vitamin C, Ampicillin, dextra-propoxyphen,

propoxyphen, Citrenalol, propanolol
Page 33 of 69
6. PRODRUG DESIGN 6 hrs
Introduction, chemical
mical bond, gastrointestinal absorption, parenteral administration, distribution,
transdermal absorption, pharmacokinetics and biopharmaceutical aspects, rational of prodrug design
and practical considerations
HOME ASSIGNMENT
v Recent advances and trends

ends in the above mentioned categories of drugs.
REFERENCES
1. Burger: Medicinal Chemistry series, John Wiley & Sons N.Y.

2. Foye: Principals of Medicinal Chemistry (Varghese & Co.)
3. Lednicer: Organic drug synthesis Vol.1,2,3,4; John Wiley & Sons N.Y.
4. Ariens: Medicinal Chemistry series.
5. Elies & West: Progress in Medicinal Chemistry series.
6. Wilson & Gisvold: Text book of Medicinal Chemistry, J. B. Lippin
7. Comprehensive Medicinal Chemistry series II-IV, Academic Press.
8. Combinational Chemistry
Chemistry-synthesis and applications- Stephen R. Wilson
9. Recent advances in chiral separations, Ed. Stevenson & Wi, Latest 1990, Plenum Press.
10. Chiral Technology, R. A. Steldon, Marcell Dekker Inc. New York.
11. Combinatorial Chemistry Ed. Fennirl Hicham 2000 Oxford University
Page 34 of 69
M
M.Pharm. Syllabus
ACEUTICAL CHEMISTRY
(
Subject: Drug Design (4 Credits)
-----------------------------------------------------------------------------------------------------------------------
1. DRUG DISCOVERY 5 hrs
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.
2. APPROACHES TO THE RATIONAL DESIGN OF ENZYME INHIBITORS 8 hrs
a. Introduction
i) Enzyme inhibitors in Medicine
ii) Enzyme inhibitors in basic Research
iii) Drug Design based on Antagonism and Enzyme Inhibition
b. Rational design of non covalently & covalently binding enzyme inhibitors
Rapid reversible inhibitors, slow & tight binding inhibitors, Transition state analogs,
multisubstrate inhibitors.
4. QUANTITATIVE STRUCTURE ACTIVITY RELATIONSHIP 12 hrs
a. History and development
elopment of QSAR
b. Drug-Receptor
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
regression analysis, partial
partial-least
least square analysis (PLS) and other
multivariate statistical methods
f. 2D and 3D QSAR approaches
5. MOLECULAR MODELING 20 hrs
a. introduction to Molecular Modeling
Modeling- concepts and methods
b. Molecular mechanics-ForceForce field (potential energy function)
c. Quantum Mechanics- Calculation of affinity, unknown receptors, Pharmacophore models
d. Known receptor sites
e. Searching for similarity, molecular comparison and finding common pattern
f. Energy Minimization methods
methods-Steepest, desent, conjugate gradients,
ients, Newton methods (Non
mathematical)
g. Conformational Analysis
i) Systematic search
Page 35 of 69
ii) Monte Carlo Simulations
iii) Molecular Dynamics Simulations
h. Ligand design based on 3D structure
HOME ASSIGNMENT
v Study of software for QSAR, Docking, Molecular modeling and proteprotein
in sequencing.
REFERENCES
1. QSAR & Strategies in the design of Bioactive Compound J. K. Seydel
Latest after 1984 Deuts che Bibliofech.
2. Nucleic acid targeted Drug Design Propst & Thomas 1997 Marcel
Decker.
3. Structure based Drug Design Pandi veera Pandian 1997 Merck Decker
4. A Guide to chemical Basis of Drug Design Burger Alfred 1997 Wiley
interscience.
5. Computer aided Drug Design Perun 1st 1989 / Latest Marcel Decker
6. Computational Medicinal Chemistry for Drug Design Patrick Bultinck
1st 2004 Marcel Decker.
7. Nucleic acid targeted Drug Design Propst & Thomas 1997 Marcel Decker
8. Principles of Drug Design by Smith
9. Strategy of Drug Design by Brucell
10. The organic chemistry of the Drug Design and Drug action by Richard B. Silverman
11. Introduction to o Quantitative Drug Design by Y.C.Martin
12. Drug Design volumes by Ariens
13. QSAR: Hansch Analysis and Related Approaches by Hugo Kubinyi
14. Textbook of Drug Design and Discovery, Third Edition, Larsen, Liljeors and Madsen
Page 36 of 69
M
M.Pharm. Syllabus
ACEUTICAL CHEMISTRY
(
Subject: t: Laboratory Course 3 08 hrs / wk (44 Credits)
------------------------------------------------------------------------------------------------------------------
Mixture analysis of 2/3 organic compounds (At least 6)
1. Synthesis of drugs using 3/4 steps, and/ OR Synthon approach and their structure confir
confirmation.
(At least 3)
2. To perform the following reaction of synthetic importance (Any 3)
a. Birch reaction
b. Clemmensons reduction
c. Meerwin-Pondroff,s
Pondroff,s reduction
d. Grignard reaction
e. Oppeneaur oxidation
f. Benzylic acid rearrangement
g. Beckmann rearrangement
REFERENCES
1. Organic synthesis: Fisher and William Son (CBA Publisher)

2. Mann and Saunders, Practical Organic chemistry (Orient Longman)
A.I.Vogel, Practical Qualitative and Quantitative Organic Chemistry (Orient Longman)
4. Systematic Identification of Org. Compounds Shriner & Herman 1998 John Wiley & sons
5. Reaction Synthesis in Organic Chemistry Laboratory Tiezel/ Ether 1989
University Science.
Page 37 of 69
M
M.Pharm. Syllabus
ACEUTICAL CHEMISTRY
(
Subject: Laboratory Course 4 08 hrs / wk (4 Credits)
-----------------------------------------------------------------------------------------------------------------------
1. Synthesis of drugs mentioned in the theory using basic operations like molecular distillation,
fractional crystallization and purificati
purification
on by column chromatography, preparative TLC and
structural confirmation by spectroscopic methods. (At least 4)
2. Isolation, characterization like melting point, mixed melting point, molecular weight
determination, functional group analysis co chromatographi
chromatographicc techniques for identification of
isolated compounds and interpretation of UV&IR data of following (Any 8)
a. Eugenol from Clove
b. Curcumin from Turmeric
c. Sennosides from Senna
d. Hesperidine from Orange peel
e. Embelin from embela Ribes
f. Glycyrrhizin from glycyrrhiza glabra
g. Plumbigin from Plumbago Rosea
h. Solarin from potato
i. Naringen from grape fruit peel
j. Trimystin and Myristin from Nutmeg
k. Azylic acid from Castor oil
l. Pectin from Orange peel
m. Lycopene from Tomato peel
n. Epicatechin from Cashew w kernel, outer kernel
o. Piperin from Black pepper
REFERENCES
1. Mann and Saunders. Practical Organic Chemistry (orient Longman)

2. A. I. Vogel, Practical Qualitative and Quantitative Organic Chemistry
3. Modern methods of plant analysis Peech and M. V. Tracey
4. Phytochemistry Vol I & II by Miller, Jan, Nostrant, Rein Hid
5. Recent advances in Phytochemistry Vol. I & IV Scilicet, Runeckles
6. Natural Product Chemistry A laboratory guide by Rapheal Ikan
Page 38 of 69
M
M.Pharm. Syllabus
M. Pharm. (Seme
emester II) QUALITY ASSURANCE
(
Subject: Pharmaceutical Validation (4 Credits)
1. Introduction to Pharmaceutical Validation: Definition, Manufacturing Process Model,
scope of Validation, Advantage of Validation, Organization for Validation, Validation Master
plan, User Requirement Specification (URS), Design Qualification (D.Q.), Installation
Qualification
tion (IQ), Operational Qualification (OQ) & Process Performance Qualification (P.Q.)
of facilities.
2. Validation related documents: Validation and types of validation, protocols, methodology
and related GMP/ICH guidelines.
3. Validation of Equipment: Validation of following equipment
- Dry Powder Mixers
- Fluid Bed and Tray dryers.
- Tablet Compression Machine.
- Dry Heat Sterilization
- Autoclaves
- Capsule filling machines.
- Validation of existing equipment.
4. Vendor Certification
5. Utilities Validation: Validation of Pharmaceutical Water System & pure steam, Validation of
Compressed air
6. Cleaning Validation: Cleaning of Equipment, Cleaning of Facilities
7. Analytical Method Validation:: Basis concepts for development and validatio
validation of analytical
and bio analytical method as per ICH guidelines.
Validation of following analytical Instruments
- HPLC
- Dissolution test apparatus
- U.V./Visible spectrophotometers
8. Process Validation
Prospective, concurrent, retrospective & revali revalidation,
dation, Process validation of following
formulations
- Coated tablets
- Capsules
- Ampoules & Vials
- Ointment/Creams
- Liquid Orals
9. Computer System Validation
References:
1. S. Weinberg, Good laboratory practice Regulations, Marcel and Dekker.

2. J. Swarbrick Boylan, Encyclopedia of Pharmaceutical Technology, Marcel and
Dekker.
Page 39 of 69
3. J.R. Berry and R.A. Nash, Pharmaceutical process validation. Marcel and Dekker.
4. S.H. Will and J.R. Stoker, good manufactur
manufacturing Practices for Pharmaceutics Marcel Dekker.
5. R.F.
.F. Brewer, Design of experiments for process improvement and quality
Assurance Narrosa.
6. B. Othery. ISO 14000 and ISO 9000 Gower.

7. D.H. Stamatis, Understanding ISO 9000 and implementing the basics to quality;
Marcel Dekker.
8. J. F. Despautz, Automation and validation of information in Pharmaceutical Processing Marcel and
Dekker.
9. F.J. Carleton and J.P. Agalloco validation of aseptic Pharmaceutical processes Marcel and Dekker.
10. S. C. Chowand J.P. Liu statistical Design and Analysis in Pharmaceutical Scienc
Sciences.
es. Marcel,Dekker.
11. DeSpautz.J.F.Automation and Validation of information in Pharmaceutical Processing Marcel
Dekker, New York.
Page 40 of 69
M
M.Pharm. Syllabus
M. Pharm. (Seme
(
Subject:
t: Product Development (4 Credits)
1. Pilot Plant Scale Up Techniques: Significance of pilot plant scale up study and large scale
manufacturing techniques (formula, equipment, process, stability and quality control) of some
important dosage forms such as tablets, capsules, injections, liquid orals, semisolids, ophthalmic
products, emulsions including multiple emulsions.
2. Optimization
on techniques in pharmaceutical Formulation and processing: Concept of optimization,
Optimization parameters, Classical optimization, Statistical design, and Optimization methods.
3. Preformulation Studies: pka and solubility, kinetic pH profile, partition coefficient, crystal
morphology, polymorphism, powder flow, surface characteristics, dissolution, compatibility studies,
protocol for performulation studies.
4. Solubilization Techniques: Determination of solubility, solubility parameters, methods of

solubilization
bilization including addition of cosolvent, surface active agents, complexation, dielectric constant,
hydrotrophy, chemical modification.
5. Drug stability: solution stability, solid state stability, parameters for physical stability testing,
programme, Acceterated studies and shelf life assignment.
6. Product development of solid, liquid, semisolid and parenteral dosage form

forms.
References:
a. N. G. Stanley Wooed; Enlargement and compaction of particle solids; Butterworths.

b. D. M. Parikh; Handbook of Pharmaceutical Granulation Technology; Marcel Dekker.
c. H. G. Brittain; Physical Characterization of Pharmaceutical solids; Marcel Dekker.
d. A. Kitahard and A. Watanabe;be; Electrical Phenomena at Interfaces; Marcel Dekker.
e. J. T. Cartensen; Drug Stability; Marcel Dekker.
f. G. Alderborn and C. Nystrom; Pharmaceutical Powder Compaction Technology; Marcel Marcel, Dekker.
g. A. Martin, P. Bustamante and A. H. Chun; Physical Pharmacy; WavWaverly.
h. Lieberman, Rieser and Banker; Pharmaceutical Dosage Forms; Disperse system; MarcelDekker.
i. M. N. Rubinstein; Pharmaceutical Technology, Drug stability, John Wiley and sons.
j. Martin Rhodes; Principles of Powder Technology, John Wiley and sons.
k. James J. Wells; Pharmaceutical Preformulation, Ellis Harwood Ltd.
l. P. J. Tarcha; Polymer for Controlled Drug Delivery, CRC Press.
m. P. H. List and P. C. Schmidt; Pharmaceutical Technology, CRS Press.
n. Robinson; Novel Drug Delivery Systems, Marcel Dekker.
o. N. K. Jain; Pharmaceutical
armaceutical product development, CBS publishers and distributors.
Page 41 of 69
p. K. E. Avis, H. A. Liberman and Lanchman; Pharmaceutical dosage forms: Parenteral Medications:
Vol. 1, 2, 3, Marcel Dekker.
q. Remingtons Pharmaceutical Sciences by Osol
r. Lachman, Theory & Practice
ctice of Industrial Pharmacy
s. Cartensens , Pharmaceutics of Solids and Solid dosage form
t. bean & Beckett, Advance in Pharm. Sciences
Page 42 of 69
Page 43 of 69
M
M.Pharm. Syllabus
M. Pharm. (Seme
(
Subject:
t: Quality Management (4 Credits)
1. Concept of Total Quality Management, Philosophy of GMPS and GLPS, ISO9000.
2. Organization and personnel, responsibilities, training hygene, personnel records.
3. Premises: Location, design, plant layout, construction, maintenance of sterilite areas, control of
contamination.
4. Equipment, selection, purchase specifications, maintenance clean in pla

place and sterilize in place.
5. Raw materials; purchase specifications, stores selection of vendors, controls on raw materials.
6. Manufacture of and controls on various dosage forms, manufacturing documents, Master Formula,
Batch formula records, Standard Operation
peration Procedure, Quality audits of manufacturing processes and
facilities.
7. In-process
process quality controls on various dosage forms sterile and nonsterile. Standard Operation
Producers for various operation like cleaning, filling, drying compression, coating,
ing, disinfection,
fumigation, sterilization, membrane filtration etc.
8. Six sigma methodology
9. Pharmaceutical Packaging: Introduction to pharmaceutical packaging, types of packaging material,

quality control of packaging material such as glass, plastic and rubber etc.
References:
1. B. Othery. ISO 14000 and ISO 9000 Gower.

2. D. H. Stamatis, Understanding ISO 9000 and implementing the basics to quality; Marcel
Dekker.
3. J. Swarbrick Boylan, encyclopedia of pharmaceutical technology, Marcel and Dekker.
4. J. R. Berry and R. A. Nash, Pharmaceutical process validation. Marcel and Dekker.
5. R. F. Brewer, Design of experiments for process improvement and quality Assurance Narrosa.
6. 6. S. Weinberg, Good laboratory practice Regulations, Marcel and Dekker.
7. 7. S. H. Will and
d J. R. Stoker, good manufacturing Practices for Pharmaceutics Marcel Dekker.
8. Risk Assessment and Risk Management in the Pharmaceutical Industry Clear and Simple,
James L. Vesper, PDA book store.
9. Kennedy T. Pharmaceutical Project Management Marcel Dekker Dekker,, New York.
10. Improving Quality through planned experimentation By Moen: Tata McGraw Hill, India
11. Assurance of Quality, Pharmaceutical Total Quality Approach, M. S. P. Khan,
Chitgaon, Bangladesh, Signet Press
Press-1990
Page 44 of 69
M
M.Pharm. Syllabus
M. Pharm. (Seme
(
Subject:
t: Laboratory Course 3 08 hrs / wk (4 Creedits)
1. Preformulation study
2. Product development: a case study
3. Determination of tensile strength of various films used for formulation and bulk
Packaging of pharmaceuticals
4. Testing of containers, closures, liners, glass, plastics used for packaging
5. Test for packaging

kaging materials, cartons, aluminium foils, strip packing, blister
packing, ampoules, vials etc.
6. Assessment of stability studies according to ICH guidelines
7. Prediction of shelf life by accelerated stability study
8. Validation of various equipments

ipments like autoclave, hot air oven, powder mixer, tablet
compression machine, fluidized bed dryer etc.
9. Validation of a process like cleaning of equipments, mixing, drying, compression
etc.
10. Designing and optimization of dosage forms by ffactorial design.
11. Design of experiments based on theory topics.
RECOMMENDED BOOKS:
Page 45 of 69
M
M.Pharm. Syllabus
M. Pharm. (Seme
(
Subject:
t: Laboratory Course 4 08 hrs / wk (4 Creedits)
1. Calibration of analytical instruments like UV
UV-Visible, IR Spectrophotometer, HPLC, HPTLC,
spectrofluorimeter, GC etc.
2. Determination of water content
3. Detection and determination of preservatives, antioxidants, coloring materials and excipients in

dosage forms.
4. Determination of related substances in excipients and drugs
5. Determination
ination of active constituents from crude drugs.
6. Quality control tests for some herbal formulation
7. Phase solubility analysis
8. Determination of -amino
amino acid using pH meter
9. Assay of API in sample using HPTLC/HPLC
10. Determination of max of given sample using spectrophotometer and validity of
Lamberts-Beer Law
11. Microbial limit test of various excipients like starch, acacia, gelatin etc.
12. Sterility testing of Pharmaceuticals
13. Design of experiments based on theory topics.
RECOMMENDED BOOKS:
Page 46 of 69
M
M.Pharm. Syllabus
M. Pharm. (S
Semester II) PHARMACOLOGY
(
Subject:
t: Molecular Pharmacology (4 Credits)
1. Introduction to Molecular Pharmacology, Techniques to study molecular

pharmacology such as Western Blotting, Immunostaining, Cloning, Cell Culture.
Recombinant DNA technology and its applications.
2. Gene therapy, antisense therapy, aptamers therapy, stem cell - Concept and recent
development in the treatment of vvarious diseases.
3. Transgenic mouse and its applications. Human genome mapping and its potential in
drug research.
4. Endogenous bioactive molecules as TNF , Interleukins, process of apoptosis,
TNF-,
arachidonic acid metabolites, COX
COX-22 regulators and their role in inflammation.
Endothelium derived vascular substanc
substances such as NO, endothelins and their
modulators.
5. Molecular Mechanism of drug action: Receptor occupancy and cellular signaling
system such as G-Protein,
Protein, cyclic nucleotides, calcium and phosphatidyl inositol, Ionic
channels and their modulators.
Recent trends on different classes of receptors and drugs acting on them.
_ Cholinergic receptors.
_ Dopamine receptors.
_ Serotonin receptors.
_ Hormone receptors.
_ GABA receptors.
_ Opioid receptors.
_ Purinergic receptors.
_ Glutamate receptors.
6. Molecular biology of cancer:: Causes of cancer and genetics of cancer, new strategies
for combating cancer.
References:
1. Goodman and Gilman, Pharmacological Basis of Therapeutics, Mc Graw Hill
2. Craig C R and Stitzel B E, Modern Pharmacology with Clinical Application,
LippincottWilliams & Wilkins.
3. Katzung B G, Basic and Clinical Pharmacology, Lange Medical Publisher, USA
Page 47 of 69
4. Melmon K L and Morelli, Clinical Pharmacology: Basic Principles of Therapeutics,
McMillan, New York
5. Bacq Z M, Fundamentals of Biochemical Pharmacology.
6. Grollman Pharmacology and Therapeutics, Lea & Tebiger, Philadelphi
Philadelphia.
7. Harrisons Principles of Internal Medicine, McGraw Hill.
8. Davidsons Principles and Practice of Medicine, Churchill Livingston.
9. Lawrnce D R and Bennette, Clinical Pharmacology.
10. Goldstein, Aranow & Kolman, Principles of Drug Action.
11. Rangg H P, Dale M N, Pharmacology, Churchill Livingston, UK
12. Drill V A, Pharmacology in Medicine, McGraw Hill, New York.
13. Review articles and Research articles from Medical and Pharmacological Journals
Page 48 of 69
M
M.Pharm. Syllabus
M. Pharm. (S
(
Subject:
t: Clinical Pharmacokinetics (4 Credits)
1. Introduction: Basic concepts of ADME profile of drugs, absorption rate constant,

volume of distribution, elimination rate constant, clearance, extraction ratio, area under
curve (AUC), protein and tissue binding. Calculation of parameters from plasma and
urine data.
2. Bioavailabilityy and Bioequivalence: Principles, objectives, protocols and variation
of bioavailability & bioequivalence, measurement, designing of bioavailability studies &
interpretation of results, Physiological, physico
physico-chemical
chemical & formulation factors affecting
bioavailability,
ilability, enhancing bioavailability of drug products.
3. Integration with Kinetics: Interrelation between kinetic parameters and
physiological variables, drug disposition, induction and inhibition of metabolism.
4. Basic concepts of compartment modeling with reference to some therapeutic agents.
5. Pharmacokinetics of multiple dosing & its determination, Chronopharmacokinetics,
individualization of drug therapy. Non Non-linear
linear pharmacokinetics like saturable
enzymatic process, examples of drugs that follow non-linearlinear pharmacokinetics and its
clinical implications.
6. Altered kinetics in pregnancy, child birth, infant and geriatrics; Kinetics of drugs & its
clinical implications in GI diseases, malabsorption syndrome, liver, cardiac, renal and
pulmonary diseases;
eases; genetic based altered drug kinetics, kinetics clinically harmful drug
interaction; some case studies of altered kinetics in above conditions.
References:
1. Malcolm Rowland and Thomas Tozer, Cli Clinical
nical Pharmacokinetics: Conceptand
Concept
Application, Lea andd Febiger, Philadelphia.
2. Abdou H M, Dissolution, Bioavailabilty & Bioequivalance, Mack Publishing
Company, Pennsylvania.
3. Shargel L and Yu ABC, Applied Biopharmaceutics & Pharmacokinetics, Connecticut,
Appleton Century Crofts.
4. Milo Gibaldi, Biopharmaceutics and Clinical Pharmacokinetics, Lea and Febiger,
Philadelphia.
5. Milo Gibaldi and Laurie Prescott, Hand Book of Clinical Pharmacokinetics, Adis
Health Science Press, New York.
Page 49 of 69
6. John Wagner and M Pernarowski, Biopharmaceutics and Relavant Pharmacokinetics,
Drug Intelligence Publication, Hamilton.
7. Robert E Notari, Biopharmaceutics and Clinical Pharmacokinetics, Marcel Dekker
Inc., New York.
8. Swarbick J, Current concept in Pharmaceutical Sciences: Biopharmaceutics, Lea and
Febiger, Philadelphia.
9. Niazi, Biopharmaceutics and Clinical Pharmacokinetics, Prentice Hall, London.
10. Gennaro A R, Remington: The Science & Practice of Pharmacy, Lippincott (Recent
edition).
11. Larry Bauer and P B Bauer, Clinical Pharmacokinetics, McGraw Hill.
12. Michael E Winter, Basic Clinical Pharmacokinetics, Lippincott Willams and
Wilkins.
13. Brahmankar D M and Jaiswal S B, Biopharmaceutics and Pharmacokinetics: A
Treatise,Vallabh Prakashan, Delhi.
14. Larry Bauer, Applied Clinical Pharmacokinetics, McGraw Hill Medical
Page 50 of 69
M
M.Pharm. Syllabus
M. Pharm. (S
(
Subject:
t: Pharmacological Screening Methods (4 Credits)
1. Drug Discovery Process: Principles, techniques and strategies used in new drug
discovery, basic concepts of combinatorial chemistry, high through screening, cell
lines, and their applications; Standard techniques used in laboratory animals,
euthanasia of experimental animals, Regulations for laboratory animal care and ethical
requirements.
2. Principles of toxicity evaluations, ED50, LD50 and TD value estestimation.

imation. International
guidelines and regulatory agencies for toxicity studies like ICH, OECD, FDA, WHO
etc. Statistical methods used in biological standardization.
3. Preclinical screening of the drugs acting on

Autonomic nervous system: Parasympathomimetics, Parasympatholytics,
Sympathomimetics, Sympatholytics
Central nervous system- Sedatives, hypnotics, anxiolytics, antidepressants,
antipsychotics, analgesics, antipyretics, anticonvulscents, antiparkinsonian
Cardiovascular system- Cardiac glycosides, antiarrhythmic, antithypertensives,
Respiratory system- bronchodilators, antitussives, Antiasthmatics
Gastrointestinal tract
Immune system- Fc-receptors
receptors on T and B lymphocytes, Antibody dependent
ndent and
cellular cytotoxicity - Anti-inflammatory
inflammatory
Endocrine system- Hypoglycemics, AntiAnti-thyroid agents
Urinary system- Diuretics
Reproductive system- antifertility agents, androgens
4. Alternatives to animal screening procedure, cell line handlin

handling,g, maintenance and
propagation of cell lines, their uses and limitations, in
in-vitro
vitro testing of drugs.
References:
1. Laurence D R and Bacharach A L, Evaluation of Drug Activities: Pharmacometrics,
Academic Press, London & New York.
2. Nodine J H and Siegler P E, Animal and Clinical Pharmacological Techniques in Drug
Evaluation, Year Book Medical Publishers.
Page 51 of 69
3. Turner R A and Hebbron P, Screening Methods in Pharmacology, Vol I & II,
Academic Press, New York.
4. Vogal H G, Drug Discovery and Evaluation, Pharmacological Assays, Springer_verlog
Berlin Heidelberg.
5. Goldstein A, Aronow L and Kalman S M, Principles of Drug Actions: The basis of
Pharmacology, John Wiley and sons, New York.
6. Kulkarni S K, Handbook of Experimental Pharmacology, Vallabh Praka
Prakashan,
shan, Delhi.
7. Ghosh M N, Fundamentals of Experimental Pharmacology, Scientific Book Agency,
Kolkatta.
8. Sheth U K, Dadkar N K and Kamat U G, Selected topics in Experimental
Pharmacology, Kotari Book Depot, Mumbai.
9. Jann Hau, Handbook of Laboratory Animal Science, Animal Models, Vol I and II.
10. Perry W L M, Pharmacological Experiments on Isolated preparations, E & S
Livingstone, London.
11. Burn J H, Practical Pharmacology, Blachwell Scientific Co., Oxford.
12. Jaju B P, Pharmacology: A Practice Ex
Excersise
cersise Book, Jaypee Brothers, New Delhi.
13. Parmar N S and Shivkumar, Pharmacological Screening Methods.
14. Review articles published in various medical and pharmaceutical journals and
CPCSEA, OECD, FDA, WHO, ICH guidelines from respective website.
Page 52 of 69
M
M.Pharm. Syllabus
M. Pharm. (S
(
Subject:
t: Laboratory Course 3 08 hrs / wk (4 Credits)
1. Experiments based on determination of physicochemical properties of drugs&
dosage forms.
2. Comparison of dissolution of different marketed products of drug.
3. To determine K , biological half
half-life,
life, AUC and other pharmacokinetic parameters
a
of drug/s by urinary excretion method.

4. Calculation of various pharmacokinetic parameters after an IV bolus dose
5. To determine protein-binding
binding of drugs.
6. To study the influence of urinary pH on drug excretion.
7. Calculation of K , K , t , C and T from the given data.
a e max max
8. Calculation of AUC and bioequivalence from the given data

9. Experiment based on bio-availability
availability studies of different drug formulations
10. To perform bioequivalence testing on marketed preparations.
11. Toxicological:
a) Regulations and guidelines of toxicity studies.
b) Method of calculation of LD50
c) Observation of behavioral changes in animals during acute and sub
sub-acute
toxicity study of test drugs.
12. Statistical evaluation of given data/s and finding level of significance.
significance
13. Hand on experience on online/offline/op
online/offline/open source statistical and pharmacokinetic
softwares.
Page 53 of 69
M
M.Pharm. Syllabus
M. Pharm. (S
(
Subject:
t: Laboratory Course 4 08 hrs / wk (4 Credits)
*Module-11 is compulsory. From module
module-2 to 5 any ten practicals
racticals shall be conducted
covering all four modules. Right side figure indicates maximum practical conduced from
that module.
Module-1:: Prerequisite and introductory practicals (03)

1. CPCSEA regulations, Maintenance of experimental animals, Animal house facility
asper regulations, Procedure for registration of animal house facility, Diffe
Different
forms, Constitution, role and responsibility of IAEC.
2. Introduction to experimental animals, Methods of breeding, Biological (Scientific
name, special characteristics, food and water intake, uses, strains etc.), normal
physiological and biochemical val values of various parameters
3. Handling and drugg administration to experimental animals.
4. Use of anesthetics, Demonstrations of methods of collection of blood from
experimental animals, various methods of euthanasia and cannulation of veins,
arteries, trachea, Identification of phases of estrous cycle in rats.
Module-2: Screening of drugs (05)
To perform neurobehavioral study using various screening methods
1. To study locomotor activity by using Actophotometer.
2. To study analgesic effect by using Eddys hot plate /Analgesiometer
Analgesiometer/ tail flick
latency test.
3. To study the effect of carrageen induced Paw edema in rats by using digital
Plethysmometer.
4. To study the anticonvulsant effect of Phenobarbitone against chemicall
chemically and
electrically induced convulsions in rats.
5. To study effect of Pentobarbitone sodium on righting reflex in mice.
6. To study Anti-anxiety
anxiety effect of diazepam in mice usin
usingg elevated plus maze
apparatus/ Irwins method
method/ Elevated plus maze/ Water maze/ Zero maze.
aze.
7. To study the Apomorphine induced compulsive behaviour (Stereotype) in mice.
8. To study the muscle relaxant property of Diazepam in mice using ratarod.
9. To study Acetic acid induced writhings in mice.
10. To study Clonidine induced twitches in mice.
11. To study Pole climb avoidance in rats.
12. To study Neuroleptics induced catalepsy in rats
rats.
Module-3: Bioassays of drugs (03)
Page 54 of 69
To study DRC, CRC, potency andb andbioassays of agonist and antagonist (e.g.
( Ach,
Histamine, oxytocin, Pancuranium, 55-HT, Atropine, cyproheptidin etc.)) on different
isolated tissue preparations like,
Rat ileum
Guinea pig ileum
Rat stomach strip
Rat anococcygeus muscle
Guinea pig trachea and other suitable preparations
Module-4:: Software and data acquisition based practicals (04)

A. EP-DOG
DOG (Simulation of dog blood pressure experiment)
B. To study working of BioPac or any other data acquisition system and setting of
Physiologic and animal experimentation like,
1. To record temperature using thermal transducer
2. To measure blood pressure uusing Blood pressure transducer
3. To measure drug response curve using isotonic transducer
4. Measurement of isometric contraction using force displacement transducer.
5. To measure a change in volume using volume transducer
6. To measure a respiration using a respira
respiratory transducer
7. To study various transducers and couplers
8. To study ECG using ECG coupler with BioPac
9. To measure vital capacity, forced expiratory volume etc., using isotonic
transducer and spirometer
spirometer.
Module-5: Invasive/ In-vivo

vivo experiments (01)
1. Determination of effect of different drugs on rat blood pressure experiments.
2. To study proliferative phase in inflammation using cotton wool granuloma.
3. To study antisecretory and ulcer protective effect of Cimetidine in pylorus ligated
rats.
Page 55 of 69
M
M.Pharm. Syllabus
M.. Pharm. (Semester II)
PHARMACEUTICS
ARMACEUTICS / PHARMACEUTICAL CHEMISTRY / PHARMACOLOGY
ACOLOGY
/ QUALITY ASSURANCE
(Elective Subject)
Subject code: MPHE - 206
Subject: Industrial Pharmacy (4 Credits)
C
1. PREFORMULATION 10 Hours
Introduction, organoleptic properties, purity, particle size, shape, and surface area. Solubilisation,
surfactants and its importance, temperature, pH, co co-solvency;
solvency; Techniques for the study of crystal
properties and polymorphism. Physicochemical characteristics of new drug molecules with respec respect to
different dosage forms.
2. COMPACTION AND COMPRESSION 6 Hours
Compaction of powders with particular reference to distribution and measurement of forces within the
powder mass undergoing compression including
including- physics of tablet compression; Effect of particle size,
moisture content, lubrication etc on strength of tablets.
3. OPTIMIZATION TECHNIQUES IN PHARMACEUTICAL FORMULATION AND PROCESSING 5 Hours
Concept of optimization, Optimization parameters, Classical optimization, Statistical design, and
Optimization methods.
4. PILOT PLANT SCALE UP TECHNIQUES 10 Hours
Significance of pilot plant scale up study and large scale manufacturing techniques (formula,
equipment, process, stability and quality control) of some important dosage forms such as tab tablets,
capsules, injections, liquid orals, semisolids, ophthalmic products, emulsions including multiple
emulsions.
5.. METHODS OF ENHANCING BIOAVAILABILITY 7 Hours
Solubilization,
ation, Prodrugs, and enhancement of dissolution characteristics, cyclodextrin, permeation
enhancer, solid dispersion, surfactant, bioavailability enhancers.
6. SURFACTANT SYSTEM 7 Hours

Introduction, micellization,
zation, thermodynamics and kinetics of micelle formation, classification.,.
Pharmaceutical aspects of Solubilization
Solubilization, Solubilization in non-aqueous
aqueous system, interactions with
polymers and oppositely charged species. Surfactants in emulsions and suspensions. drug absorption,
antibacterial activity.
HOME ASSIGNMENT:
Optimization & Pilot plant scale up techniques for Tablets & Capsules
Capsules- an overview.
Automation & Effluent testing and Treatment in Pharmaceutical industries.
Industrial hazards- Monitoring and preventive systems (Safety measures)
REFERENCE BOOKS:
1. Theory and Practice of Industrial Pharmacy By Lachmann and Libermann.
2. Pharmaceutical dosage forms: Tablets Vol. 11-3 by Leon Lachmann.
Page 56 of 69
3. Pharmaceuticalal Dosage forms: Disperse systems, Vol, 11-2; By Leon Lachmann.
4. Pharmaceutical Dosage forms: Parenteral medications Vol. 11-2; Leon Lachmann.
5. Modern Pharmaceutics; By Gillbert and S. Banker.
7. Advances inn Pharmaceutical Sciences Vol. 11-5; By H.S. Bean & A.H. Beckett.
8. Physical Pharmacy; By Alfred martin
9. Bentleys Textbook of Pharmaceutics Rawbins.
10. Good manufacturing practices for Pharmaceuticals: A plan for total quality
control, Second edition; By Sidney H. Willig.
11. Drug formulation manual; By D.P.S. Kohli and D.H.Shah. Eastern publishers,
New Delhi.
12. Pharmaceutical Preformulations; By J.J. Wells.
Page 57 of 69
M
M.Pharm. Syllabus
PHARMACEUTICS / PHARMACEUTICAL CHEMISTRY / PHARMACOLOGY
ACOLOGY /
QUALITY ASSURANCE
(Elective Subject)
Subject:
t: Natural Products (4 Crredits)
1. NATURAL PRODUCTS AS LEADS FOR NEW PHARMACEUTICALS 5 hrs
a. Introduction
b. Primary and secondary metabolites in plants
c. Study of natural products as leads like cannabinoids, etoposide, teniposide, khellin, artemisin
etc.
2. ALKALOIDS 8 hrs
a. Detailed chemistry and properties of alkaloids
b. Isolation, purification and structural elucidation of morphine, vinc
vincristine,
ristine, reserpine, ephedrine
and atropine.
3. STEROIDS 8 hrs
a. General introduction
b. Stereochemistry, nomenclature and structural elucidation of sterols (cholesterol), sapogenin
(diosgenin), and solasodine.
4. FLAVONOIDS 4 hrs
Detailed chemistry and properties of Flavonoids and chemical account of rutin & quercetin
5. ANTIBIOTICS 12 hrs
a. - Lactum Antibiotics
Mechanism of action, penicillins, cephalosporins, nocardicilins and monoba
monobactums,
ctums, carbopenams
and penams, - Lactamaseinhibitors and other -Lactum agents
b. Non Lactum Antibiotics
Aminogycosides, macrolides, linomycins & polypeptide antibiotics
6. ROLE OF RECOMBINANT DNA TECHNOLOGY AND DRUG DISCOVERY 8 hrs

Cloning DNA, expression of clonal DNA, manipulation of DNA sequence information new biological
targets for drug developments, novel biotechnology derived pharmaceutical products. Antibody,
antisense oligonucleotide therapy and gene therepy.
HOME ASSIGNMENT
Advances of the active constituents of some drugs used in the following indigenous system of medicines.
v Diabetic Therepy- Gymnes sylvestre, salacia reticulate, pterocarpus marsupiam, swertia, chirata,
trigonella, foenum-graccum
v Liver Disfunction- phyllanthus niruri
v Antitumor- curcuma longa linn, taxol, teniposide, etoposide.
Page 58 of 69
REFERENCES
1. Natural product chemistry by Nakanishi Goggolo
2. Modern methods of plant analysis Peech and M. V. Tracey
3. Phytochemistry Vol I & II by Miller, Jan, Nostrant, Rein Hid
4. Recent advances in Phytochemistry Vol. I & IV Scilicet, Runeckles
5. Natural Product Chemistry A laboratory guide by Rapheal Ikan.
6. The alkaloid chemistry
try and physiology by THF Manske
7. Introduction to molecular Phytochemistry CH Wells, Chapmannstall
8. Organic chemistry of natural products Vol I & II by Gurudeep Chatwal
9. Organic chemistry of natural products Vol I & II by O. P. Agarawal
10. Organic chemistry Voll I & II by I. L. Finar
11. Elements of Biotechnology by P. K. Gupta
12. Pharmaceutical Biotechnology by S. P. Vyas and V. K. Dixit
13. Biotechnology by Purohit and Mathoor
14. Phytochemical methods by Harborne
Page 59 of 69
M
M.Pharm. Syllabus
ACOLOGY
/ QUALITY ASSURANCE
(Elective Subject)
Subject:
t: Biological Evaluation ( Credits)
(4
1. Microbiological limit tests.
2. Sterility tests : Methodology & Interpretation
3. Tests for effectiveness of antimicrobial preservatives.
4. Preclinical Drug Evaluation acute (LD50), Subacute & chronic toxicity, Evaluation of a Compound for
its biological activity, and ED 50 determination, special toxicity tests like teratogenecity and
mutagenecity, clinical trials
5. Biological standardization:: General principles, scope and limitations of bioassay, Bioassays

Bioa of some
official drugs
6. Radioimmunoassay: General principles,

iples, scope and limitation. Radioimmunoassay of some drugs like
insulin, digitalis etc.
7. Pyrogens-Production, chemistry and properties of bacterial pyrogens and endotoxins, Mechanism of

action of pyrogens, Pharmaceuticals aspects, Pyrogen test of IP compared to that of BP & USP,
Interpretation of data, comparison of LAL and official pyrogen tests.
References:
1. S. J. Turco; Sterile dosage forms: their preparation and clinical application; Lee and Febiger.
2. Principles of Clinical Research, by G. Ignazio, Routledge; 1 edition (March 30, 2001).
3. Guide to Clinical Trials, by Bert Spilker, Lippincott Williams & Wilkins; 1st edition 1991.
4. Clinical pharmacy practice; C.W. Blissit
5. Clinical pharmacy & therapeutics;
rapeutics; Walker Edwards, Churchill Livingston
6. Analysis drug treatment
7. Bontempo J.A., development of Bio Bio-Pharmaceutical
Pharmaceutical Parenteral Dosage Forms Marcel Dekker,
Nerw York.
8. Kamalesh Kohli, Clinical Pharmacotherapecutics,
Pharmacotherapecutics edited by, Elsevier Publication.
9. J.H.
.H. Burn, D.J. Finney & L.G. Goodwin, Biological standardization
10. Issha G. Kamat, Dadkar, N.K. & Seth, Selected topics on Experiment Pharmacology.
11. L. A. Trissel: Handbook on injectable drugs; American Society for Hospital Pharmacist
Publication.
12. S. J. Turco; Sterile Dosage Forms: their Preparation and Clinical Applications; Lee and Febiger.
Page 60 of 69
Page 61 of 69
M
M.Pharm. Syllabus
ACOLOGY
/ QUALITY ASSURANCE
(Elective Subject)
Subject:
t: Clinical Pharmacology & Toxicology (44 Credits)
1. Introduction to clinical pharmacology, importance of clinical pharmacokinetics,
therapeutic-monitoring
monitoring of drugs.
2. Organization, types of clinical research; design and organization of phasephase--I to IV of
clinical studies, ethics of clinical trials
trials.
3. Drug-drug, drug-food, drug-pollutants
pollutants interactions
interactions.
4. Principles of pediatric, geriatric pharmacology; drug therapy in pregnancy and
lactation.
5. Neuropharmacology: Clinical aspects of drug therapy of Epilepsy, Parkinsons
disease, migraine,
ine, myasthenia gravis and Alzheimers disease
disease.
6. Endocrinology: Concept of Homeostasis, molecular mechanism of hormone action,
calcium homeostasis, neurohypophysial hormones, endocrine role of pineal gland.
Clinical aspects of drug therapy of diabetes, goiter, Infertility, Erectile dysfunction.
dysfunction
7. Immunopharmacology: Current concept in theory and research of vaccines, sera,
tissue transplantation; Immunostimulants, immunomodulators, immunosuppressants,
drug therapy for immune disorder and immunological investigations.
8. Current concept and research in drug therapy in cardiovascular, gastric, renal,
respiratory and hepatic disorders.
9. Infectious Pharmacology: General guidelines and clinical linical aspects of drug therapy of
infectious disorders.
11. Toxicology: General principles of toxicology, toxicological evidence, common
household poisons, qualitative & quantitative aspects of toxic effects, detoxification &
disposition Single dose and repeat dose toxicity studies; factors influencing such
studies like species, sex, size, route and dose level; regulatory requirements,
determination of effective dose & LD 50 as per international guidelines, invitro
methods of toxicology; basic concepts of toxicokinetics. Brife review of Organ and
system toxicology, Reproductive toxicology assessment, Mutagenicity and
Carcinogenicity.
References:
1. Goodman and Gilman, Pharmacological Basis of Therapeut
Therapeutics,
ics, Mc Graw Hill
Page 62 of 69
2.Craig
Craig C R and Stitzel B E, Modern Pharmacology with Clinical Application, Lippincott
Williams & Wilkins.
3. Katzung B G, Basic and Clinical Pharmacology, Lange Medical Publisher, USA
4. Melmon K L and Morelli, Clinical Pharmacology: Bas Basic
ic Principles of Therapeutics,
Mc Millan, New York
5. Bacq Z M, and Capek R, Fundamentals of Biochemical Pharmacology, Pregmon Press,
Oxford.
6. Grollman Pharmacology and Therapeutics, Lea & Tebiger, Philadelphia.
7. Harrisons Principles of Internal Medici
Medicine, McGraw Hill.
8. Davidsons Principles and Practice of Medicine, Vol I and II, Churchill Livingston.
9. Lawrnce D R and Bennette, Clinical Pharmacology.
10. Goldstein, Aranow & Kolman, Principles of Drug Action.
11. Rang H P, Dale M N, Pharmacology, Chu Churchill Livingston, UK
12. Crossland Lewiss Pharmacology, Churchill Livingstone, Edinburgh, London.
13. Drill V A, Pharmacology in Medicine, McGraw Hill, New York.
14. Roger and Walkar, Clinical Pharmacy and Therapeutics, Churchill Livingstone,
London.
15. Patten J, Neurological Differential Diagnosis.
16. Koda-Kimble,
Kimble, Applied Therapeutics: The clinical uses of Drugs.
17. Herfidal E T and Hirschman J L, Clinical Pharmacy and Therapeutics.
18. Review articles and Research articles from Medical and Pharmacolo
Pharmacological
gical Journals
19. Niesink R J M, De Vries L and Hollinger M A, Toxicology: Principles and
Applications, CRC Press.
20. Gupta P K and Salunke DK, Modern Toxicology, Vol. I, II, and III, Metropolitan,
New Delhi.
21. Gad SC, Safety assessment for Pharmaceuticals, Van Nostrand Reinhold, New York.
22. Benichou C, Adverse Drug Reaction: A practical guide to diagnosis and management,
Chichester, West Sussex, England.
23. Cobert B L, Manual of drug safety and Pharmacovigilance, Sudbury, Jones and
Bartlett Publisher.
Page 63 of 69
M
M.Pharm. Syllabus
ACOLOGY
/ QUALITY ASSURANCE
(Elective Subject)
Subject:
t: Pharmaceuticals Stability Studies (4 Crredits)
Stability aspects: Basic concept pt and objectives of stability study.
Regulatory requirement for stability studies: A very brief introduction to FDA and
WHO guidelines. Detail stuudy of ICH guidelines [Q1A (R2), Q1B, Q1C, Q1 Q1D,
Q1E, Q1F, Q5C].
Kinetic principles appliedd for stability evaluation and their applica cations in
predicting shelf life and haalf life of pharmaceutical formulations. Impoortance of
accelerated stability study.
Degradation pathways (Deegradation by hydrolytic, oxidative, reducttive,
photolytic, etc) and stabilizaation methods for formulation.
Stability indicating aassays and its importance
Stability testing and dating of solid and liquid dosage forms:
Different approach hes for stability testing of solid and liquids,
kinetic principles, physical andnd chemical stability testing of pharmaceutical al dosage
forms and packages.
Product life-cycle managem ment
Product liability and compen nsation
Stability issues related to prooteins and insulin type formulations
Stability issues related too herbal formulations, extracts, fractions and a
natural products/isolated com mpounds.
Stability issues for vaccines and biological products
REFERENCES:
1. Drug Stability, J.T. Carstenseen, Marcel Dekker, New York.
2 . Chemical Stability of Pharmaaceuticals-A Handbook for Pharmacists, Kenneth th Connors,
John Wiley and Sons, Inc.
3. Good Drug Regulatory Practtices: a Regulatory Affairs Quality Manual (Good od Drug
Development Series) Helen ne I. Dumit
4. United States Pharmacopoeeia-27(NF-22), United State of Pharmacoppeal convention,
c
INC, 12601 Twinbrook Parkw way, Rockville, MD 20852.
5. The International Pharmaco opoeia Vol. 1,2,3,4, General methods of analysiss and quality
specifications for pharmaceu utical substances, excipients, dosage forms.
6. Phytochemical Methods, J.B B.Harborne, Chapman and Hall, London and New ew York. 7.
Pharmacopoeal standards fo or Ayurvedic Formulation (Council of Research in Indian
Medicine and Homeopathy). ).
Page 64 of 69
M
M.Pharm. Syllabus
ACOLOGY
/ QUALITY ASSURANCE
(Elective Subject)
Subject:
t: Quality Assurance Approach & Improvement (4 Credits)
Quality improvement processs
Quality in research and deveelopment
Complaints and recalls: evaaluation of complaints, recall procedure, relatted
records and documents.
Quality control laboratory responsibilities and laboratory practices. Routine
controls on instruments, reeagents, sampling plans, standard test procedu dures and
protocols, control on animaal house, data generation and storage, qualityy control
documentation and audits off QC facilities.
Finished product release, quaality review, quality audits and batch release
documents. Validation annd security measures for electronic data and commputer
assisted process. Calibr
bration and validation of master plan
Cosmetics, biotechnologicall, microbiological products & regulations, meddical
device regulations; fraud andd professional misconduct
REFERENCES:
1. Encyclopedia of Pharmaceut utical Technology Vol.1-3, Swarbric, J and Bolyln
n, J.
C., Marcel Dekker, Inc., New
ew York.
2. United States Pharmacopoeeia-27(NF-22), 2004, United State of
Pharmacoppeal convention,, INC, 12601 Twinbrook Parkway, Rockville, MD D
20852.
3. The International Pharmaco opoeia Vol. 1,2,3,4, General methods of analysiss
and quality specifications fo
or pharmaceutical substances, excipients, dosagge
forms.
4. Pharmacopoeal standards fo or Ayurvedic Formulation (Council of Research in
Indian Medicine and Homeop opathy).
5. Jurans Quality Handbookk, 5th Ed, by J M Juran, A B Godfrey,
McGrawHill International Ed dition
6. Official books like IP, BP, USP,
P, etc of recent editions
Page 65 of 69
M
M.Pharm. Syllabus
ACOLOGY
/ QUALITY ASSURANCE
(Elective Subject)
Subject:
t: Sterile Products Formulation & Technology (4
4 Credits)
1. Biopharmaceutical Factors Inffluencing Bioavailability: Physicochemical innfluences
on bioavailability, Physiologic ffactors influencing drug absorption, Dosaage form
considerations, Drug absorption annd bioavailability from intramuscular injectioon. Drug
absorption from subcutaneous innjection, Biopharmaceutics of intrathecal innjections,
parenteral administration of peptidees and proteins, Parenteral drug delivery system
ms.
2. Preformulation Research: Introduction, Drug substance physicoochemical

properties, General modes of drug ug degradation, Preformulation studies for proteins
and peptides, Preformulation screenning of parenterals packaging components.
3. SVP and LVP: Introductionn to SVP, Formulation principle, Special types of

Parenteral (Suspension, Emulsionn, Dried Forms), Container effect on forrmulation,
Stability evaluation. Introductionn to LVP, Concept of formulation, Forrmulation
development, Solution Quality.
4. Sustained/Controlled Releasee Parenterals Drug products:
Biophaarmaceuti
cs, Biocompability of polymeric maaterials, Sustained/controlled release dosage form
ms: -
Aqueous solutions, Aqueous suspeensions, O il solutions, Oil suspensions,
Biocompatible carrier, Liposomes, Nanoparticles,
N Infusion devices, Prodrug.
5. Design Consideration For Pareenteral Production Facility: Introduction, Sitee

selection, Facility area use planning,
ng, Design concepts.
6. Environmental control: Inntroduction, Control of contamination,

Environmental contamination controol system design, Clean rooms, Personnel conta
tamination
control.
7. Quality Control: Sterility testinng, FDA guidelines on sterility testing, Pyroggen

testing, Particulate matter testing, annd Package integrity testing.
References:
1. K. E. Avis, H. A. Liebermann
mann and Lachman; Pharmaceutical dosage forms:
Parenteral Medications: Vol.1,
1, 2, 3, Marcel Dekker.
rms: their preparation and clinical application; 4th Edition.
2. S. J. Turco Sterile Dosage Forms:
Lee and Febiger.
3. N. K. Jain; Controlled and Noveel drug delivery: CBS Publication.
Page 66 of 69
4. J. R. Robinson and H. L. Lee; ee; Controlled drugs delivery: Fundamentals and
Applications; Marcel Dekker.
. 5 . S.P. Vyas and R. K. Khar, Controlled drug delivery: concepts and advances;
advan
Vallabh Prakashan.
6. M. J. Akers, Parenteral Quality Co
ontrol. Third Edition. Marcel Dekkers.
Page 67 of 69
M
M.Pharm. Syllabus
ACOLOGY
/ QUALITY ASSURANCE
(Elective Subject)
Subject:
t: Biomaterials for Drug Delivery (44 Credits)
1. Biomaterials: Introductionn, classification, mechanical, surface, electrocchemical,
& physiochemical propertties of biomaterials: metallic, ceramic, poolymeric,
composite, biodegradable hyydrogels, and biologic biomaterials.
2. Biodegradable polymers: Mechanisms of polymer degradation, factorrs

affecting biodegradability, various
v methods to study biodegradability: ennzyme
assays, plate tests, respiratiion tests, gas (CO2 or CH4) evolution testts,
radioactively labeled polym mers. Study of segmented co-polyesters witth
prolonged strength retentioon profiles, polyaxial crystalline fiber forming
ng co-
polyester, polyethylene glyccol-based co-polyesters, cyanoacrylate-based systems
as tissue adhesives, chitoosan-based systems.
3. Development and appliccations of new systems: Fabrication of crystalline c

fiber-forming aliphatic copolyesters,
c medical absorbable devicess, tissue
engineering systems, syntheetic vascular constructs, implantable insulin controlled
c
release systems, absorbable delivery systems, tumor immunotherapeutic sysstems.
4. Testing of biomateriaals: Biocompatibility, blood compatibiliity and

tissue compatibility of bioomaterials. In-vitro and in-vivo testing of toxicity,
sensitization, carcinogenicityy, mutagenicity testing of biomaterials.
5. Regulatory aspects of biiomaterials: Regulatory aspects of biomaterrials and

their approval status in various countries. Toxicity and interac action of
biomaterials with body com
mponents.
References:
1. Sujata V. Bhatt, Biomaterials, Springer,

S 2002.
2. Buddy D. Ratner, Fredrick J. SSchoen, Allan S. Hoffman, and Jack E. Lemons
Biomaterials Science: An intro
troduction to Materials in medicine, Academic Press, 2004.
3. Jonathan Black, Biological Perf
rformance of materials, Taylor & Francis,2006
4. C.P.Sharma & M.Szycher, Bloo od compatible materials and devices, Technomic Pu ublishing
Co. Ltd., 1991.
5. Piskin & A.S Hoffmann, Polymemeric Biomaterials (Eds), Martinus Nijhoff Publishers,
shers,
1986 6. J. B. Park, Biomaterials - SScience and Engineering, Plenum Press, 1984.
Page 68 of 69
M
M.Pharm. Syllabus
M Pharm. (Semester II)
M.
PHARMACEUTICS / PHARMACEUTICAL CHEMISTRY / PHARMACOLOGY ACOLOGY /
QUALITY ASSURANCE
(Elective Subject)
Subject:
t: Polymers in Pharmaceutics (4 Cred
dits)
1. Classification of polymers, syn
ynthesis of polymers, general methods of prreparation
of polymers like solution bulk, suspension and emulsion polymeerizations.
Properties of following comm monly used polymers such as Starch, cycloodextrins,
chitosan, gelatin, albumin, Celllulose derivatives, acrylates and poloxamers.
2. Characterization of polymers: Molecular weight and Molecular weight disstribution
of polymers, flow characterisstics, crystallinity, solubility and thermodynaamics of
polymers solutions, biodegradaability and biocompatibility testing of polymers..
3. Factors affecting selection of polymers, Effect of additives on polymer prroperties,

Effect of environmental connditions on polymer properties, Polymer propertiesp
influencing drug permeation, Fac
actors influencing kinetics of solute release.
4. Natural & Synthetic Acrylates and

a their applications
5. Biodegradable polymers and thheir application in pharmaceuticals
6. Application of polymers in susstained & controlled release drug delivery syste
tem (
Oral, Mucosal, Transdermal)
7. Applications of polymers in new

w drug delivery systems.
References:
1. J. Brandrup, E.H. Immergur; Polymer

mer Handbook; John Wiley and Sons.
2. Charles G. Gebelein, T.C. Chin and V. C. Yang; Cosmetic and Pharmaceutical App pplications
of Polymers; Plenum Press, New wwwork.
3. D.S. Soane; Polymer Applications of Biotechnology; Prentice Hall Inc.
4. J. R. Robison and V. H. Lee; Conttrolled Drug delivery- Fundamentals and Applicatiions;
Marcel Dekker.
5. N.K. Jain; Controlled and Novel Drrug Delivery; CBS
publication. 6. P. J. Tarcha; Polymers
ers ffor controlled Drug
Delivery; CRC Press
7. A. F. Kydonieus: Controlled Release
ease Technologies: Methods, Theory and Applications,
ons, Vol. I
& II CRC press Inc.
Page 69 of 69

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SWAMI RAMANAND TEERTH MARATHWADA UNIVERSITY,

PG Course in Pharmacy (M. Pharmacy)

Teaching & Examination Scheme

MPHE-101: Research Methodologogy & Biostatistics

MPHE-206: Industrial Pharmacy

Continuous Internal Assessment (CIA) End Semester Total

Continuous Internal Assessment (CIA) End Semester Total

2. Separation Techniques: Fundamental principles, theory, instrumentation and applications of Gas

3. Thermal Analysis: Theory, Instrumentation and applications of Thermogravimetric Analysis (TGA)

Immunochemical Techniques: Immunoelectrophoresis,

1. Good manufacturing practices

3. Quality control of pharmaceutical dosage forms: Solid and semi-solid

4. ICH Stability Guidelines (3 hrs)

5. Schedule M and Schedule Y (14 hrs)

2. The Indian Patent Act 1970 and Amendments.

1. Combination Drug Analysis (any two)

Vitamins, Sulphas, Analysis of Antipyretics and Analgesics, Steroidal anti-inflammatory

This should cover titrimetric, gravimetric, spectro

2. Validation of an analytical method: Calibration of instruments as per official procedure (UV,FTIR,

III. Presentation: (5 hrs)

IV. Cost Analysis of Projects and Clinical Trials (3 hrs)

VI. Home Assignment

(1) Research in education John W. Best Jems V. Kahn

(18)Lecture notes on patent TIFAC: DOC: 022, TIFAC July 2002.

l Consumer Protection Act.

2. Australian TGA guidelines (2 hrs)

2: Safety monitoring process & goo

3: Good reporting practices and ssafety signals:

4: Pharmacoepidemiology, Registters, Surveys:

1. Textbook of therapeutics Drrug and Disease Management: Eric T Herfinde

6. OCCULAR DRUG DELIVERY SYSTEMS 3 Hours

All books mentioned as reference books for theory should be used.

a. Antiviral Agents and agents under development of HIV infection.

3. PROTEINS AND PEPTIDE DRUGS 6 hrs

4. COMBINATORIAL CHEMISTRY 8 hrs

Introduction to chirality and Techniques used in asymmetric synthesis of

Vitamin C, Ampicillin, dextra-propoxyphen,

v Recent advances and trends

1. Burger: Medicinal Chemistry series, John Wiley & Sons N.Y.

1. Organic synthesis: Fisher and William Son (CBA Publisher)

1. Mann and Saunders. Practical Organic Chemistry (orient Longman)

1. S. Weinberg, Good laboratory practice Regulations, Marcel and Dekker.

6. B. Othery. ISO 14000 and ISO 9000 Gower.

4. Solubilization Techniques: Determination of solubility, solubility parameters, methods of

6. Product development of solid, liquid, semisolid and parenteral dosage form

a. N. G. Stanley Wooed; Enlargement and compaction of particle solids; Butterworths.

2. Organization and personnel, responsibilities, training hygene, personnel records.

4. Equipment, selection, purchase specifications, maintenance clean in pla

8. Six sigma methodology

9. Pharmaceutical Packaging: Introduction to pharmaceutical packaging, types of packaging material,

1. B. Othery. ISO 14000 and ISO 9000 Gower.

2. Product development: a case study

4. Testing of containers, closures, liners, glass, plastics used for packaging

5. Test for packaging

packing, ampoules, vials etc.

6. Assessment of stability studies according to ICH guidelines

7. Prediction of shelf life by accelerated stability study

8. Validation of various equipments

compression machine, fluidized bed dryer etc.

9. Validation of a process like cleaning of equipments, mixing, drying, compression

10. Designing and optimization of dosage forms by ffactorial design.

11. Design of experiments based on theory topics.

All books mentioned as reference books for theory should be used

2. Determination of water content