Swami Ramanand Teerth Marathwada University, Nanded ...

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Swami Ramanand Teerth Marathwada University, Nanded School of Pharmacy

Post Graduate Course in Pharmacy (M. Pharmacy) (Semester Pattern) (Choice Based Credit System)

Effective from 2014-15

Teaching Scheme M. Pharm. Pharmaceutics Semester-I

Subject code

Subject Title

Contact Hours/Week

Credits

L

T

Total

MPH-101 Advance Analytical Techniques 3

01

-

4

4 MPH -102 Quality Assurance of Pharmaceutical

Products 3

01

-

4

4 MPHE Elective –I 3

01

-

4

4 MPHE Elective - II 3

01

-

4

4 MPH-103 Laboratory course -1 -

-

8

4

4 MPH-104 Laboratory course -2 - - 8 4 4

MPH-105 Seminar 1 Total

25

Semester II

Subject code

Subject Title

Contact Hours/Week

Credits

L

T

Total 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


-

8

4



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 08

Total 25

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Teaching Scheme

M. Pharm. Pharmaceutical Chemistry Semester-I

Subject code Subject Title

Contact Hours/Week

Credits

L

T

Total MPH-101 Advance Analytical Techniques 3

01

-

4

4 MPH -102 Quality Assurance of Pharmaceutical Products 3

01

-

4


01

-

4


01

-

4


-

8

4



24

Semester II Subject code Subject Title

Contact Hours/Week

Credits

L

T

Total MPH-221 Advanced Organic Chemistry 3

01

-

4

4 MPH-222 Advanced Medicinal Chemistry 3

01

-

4


01

-

4

4 MPH-223 Drug Design 3

01

-

4


-

8

4



25

Semester-III





Total 25

Semester-IV





Total 25

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ost Graduate Course in Pharmacy (M. Pharmacy) Semester Pattern) (Choice Based Credit System)


Teaching Scheme

M. Pharm. Quality Assurance Semester-I


Contact Hours/Week

Credits

L

T


01

-

4

4

MPH -102 Quality Assurance of Pharmaceutical Products 3

01

-

4


01

-

4

4

MPHE Elective - II 3

01

-

4


-

8

4


MPH-105 Seminar

1 Total

25


Contact Hours/Week

Credits

L

T

Total

MPH-231 Pharmaceutical Validation 3

01

-

4

4 MPH-232 Product development 3

01

-

4


01

-

4

4 MPH-233 Quality Management 3

01

-

4


-

8

4


MPH-236 Seminar

1 Total

25

Semester-III





Total 25

Semester-IV





Total 25

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Post Graduate Course in Pharmacy (M. Pharmacy) Semester Pattern) (Choice Based Credit System)


Teaching Scheme

M. Pharm. Pharmacology Semester-I


Contact Hours/Week

Credits

L

T


01

-

4

4 MPH -102 Quality Assurance of Pharmaceutical Products 3

01

-

4


01

-

4


01

-

4


-

8

4 MPH-104 Laboratory course -2 - - 8 4


25


Contact Hours/Week

Credits

L

T

Total MPH-241 Molecular Pharmacology 3

01

-

4

4 MPH-242 Clinical Pharmacokinetics 3

01

-

4


01

-

4

4 MPH-243 Pharmacological Screening Methods 3

01

-

4


-

8

4 MPH-245 Laboratory course -4 - - 8 4


25

Semester-III





Total 25

Semester-IV





Total 25

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Swami Ramanand Teerth Marathwada University, Vishnupuri, Nanded Post Graduate Course in Pharmacy (M. Pharmacy)

Credit System (Semester Pattern) (Choice Based Credit System) Effective from October 2014

List of Elective Courses/Subjects Semester-I

MPHE-101: Research Methodology & Biostatistics MPHE-102: Drug Regulatory Affairs MPHE-103: Pharmacovigilance & Pharmacoepidemiology MPHE-104: Drug Metabolites MPHE-105: Pharmacoinformatics

Semester-II

MPHE-206: Industrial Pharmacy MPHE-207: Natural Products MPHE-208: Biological Evaluation MPHE-209 Clinical Pharmacology & Toxicology MPHE-210 Pharmaceuticals Stability Studies MPHE-211 Quality Assurance Approach and Improvement MPHE-212: Sterile Products Formulation & Technology MPHE-213: Biomaterials for Drug Delivery MPHE-214 Polymers in Pharmaceutics

I & II Semester Full Marks for each theory course: Full marks for each lab course: Full Marks for seminar:

100

100 25

IIIrd Semester Full marks for Synopsis and Presentation: Full marks for Experimental /Research Work: Full marks for End term progress and Presentation of Work:

125

375 125

IVth Semester Full Marks for Seminar on Dissertation: Full Marks for Dissertation Full Marks for Viva-voce

125 300 200

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Examination Scheme

Theory Course

Continuous Internal Assessment (CIA) End Semester Assessment (ESA)

Total Marks for

Subject Unit Test 1 Unit Test 2 Home Assignme

nt

Max Marks Duration (Hr)

Max Marks Duration

(Hr) Max

Marks Duration

(Hr) Max

Marks

01 15 01 15 20 50 02 50 100

Lab Course

Continuous Internal Assessment (CIA) End Semester Assessment (ESA)

Total Marks

for Subject

Unit Test 1 Unit Test 2 Record Book / Viva voce

Max Marks

Duration (Hr)

Max Marks Duration

(Hr) Max

Marks Duration

(Hr) Max

Marks

08 20 08 20 10 50 06 50 100

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Swami Ramanand Teerth Marathwada University, Nanded

M.Pharm. Syllabus

M. Pharm. (Semester – I)

Pharmaceutics/Pharmaceutical Chemistry/Pharmacology/Quality Assurance (Compulsory & Common Subject)

Subject code: MPH-101

Subject : Advanced Analytical Techniques (TH) (4 Credits)

----------------------------------------------------------------------------------------------------------------------

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-

liquid chromatography, HPLC, Gel chromatography, GC-MS, HPTLC, and 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, 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– Willard, Merritt, Dean, CBS-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-Part A and Part B – J. W. Munson, Marcel and Dekker (10) Indian Pharmacopoeia-2007 (11) Martindale: The complete Drug Reference – 2007 (12) Impurities Evaluation of Pharmaceuticals- Satinder Ahuja (13) Modern Instrumental Analysis, Vol 47(Comprehensive Analytical Chemistry) - Satinder Ahuja , Neil

Jespessen (14) Practical HPLC Method Development, 2nd Edition- Lloyd R. Snyder, Joseph J. Kirkland, Joseph L. Glajch

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Swami Ramanand Teerth Marathwada University, Nanded M.Pharm. Syllabus


Pharmaceutics/Pharmaceutical Chemistry/Pharmacology/Quality Assurance (Compulsory & Common Subject) Subject code: MPH-102

Subject : Quality Assurance of Pharmaceutical Products (QAPP) (4 Credits)

---------------------------------------------------------------------------------------------------------------------- 1. Good manufacturing practices: GMP in manufacturing processing and quality control of drugs, control

of facility, personal, production 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 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 Pharmaceutical Processing – J. F. Despautz,Marcel and Dekker (2) Validation of aseptic pharmaceutical processing – F. J. Carleton and J. P. Agalloco, 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 and Dekker (5) Design of Experiments for process improvement and quality Assurance – R. F. Brewer (6) Law and drug –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 and Dekker

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M. Pharm. (Semester – I) Pharmaceutics/Pharmaceutical Chemistry/Pharmacology/Quality Assurance (Compulsory & Common Subject) Subject code: MPH-103

Subject : Laboratory Course I (4 Credits) ----------------------------------------------------------------------------------------------------------------------

1. Combination Drug Analysis (any two)

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

Antihistamins.

2. Illustrations of theoretical principles using assay of drugs form in various pharmacopoeias (any

five).

This should cover titrimetric, gravimetric, spectro-photometric (including flame photometric)

methods. 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, 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

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M. Pharm. (Semester – I) Pharmaceutics/Pharmaceutical Chemistry/Pharmacology/Quality Assurance (Compulsory & Common Subject) Subject code: MPH-104

Subject : Laboratory Course 2 (4 Credits) ---------------------------------------------------------------------------------------------------------------------- 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, Digital pH meter, Digital balance, Potentiometer, HPLC, Gas

chromatography) (Minimum two practical).

3. Quality 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 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

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M.Pharm. Syllabus


Pharmaceutics/Pharmaceutical Chemistry/Pharmacology/Quality Assurance

(Elective)

Subject code: MPHE-101

Subject : Research Methodology and Biostatistics (TH) (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- internet getting patents and reprints of articles as

sources for literature survey. (2 hrs)

3. Selecting a problem and preparing a research proposal 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 packages in clinical trials

Documentation in clinical trails

5. Research report/paper writing/thesis writing / poster presentation: (10 hrs)

Different parts of research report or paper

Title-title of project with authors name

Abstract-statement of the problem, background list in brief, purpose and scope

Key words

Methodology-subject, apparatus/instrumentation and procedure

Results-tables, graphs, figures and statistical presentation

Discussion-support or non-support to hypothesis. Practical and theoretical implications

Acknowledgements

References

Errata

Importance of spell check

Use of foot notes

II. Methods and tools used in research: (5 hrs)

Research design (futures of good design, types of research designs, basic principles of

experimental design).

Qualitative studies, quantitative studies.

Simple data organization, descriptive data organization.

Limitations and sources of errors.

Enquiries in forms of questionnaire, opinionnaire and interviews

III. Presentation: (5 hrs)

Importance, types, different skills

Content of presentation format of model, introduction and endings.

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Posture, gesture, eye contact, facial expression, stage fright.

Volume, pitch, speed, pauses and languages

Visual aids and seating arrangements

Question and answer session

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

V. Biostatistics ( 10 hrs )

Statistical analysis of data including variance, standard deviation, students ‘t’ test and

ANOVA, co relation of data and its interpretation, computer data analysis, bio statistics for

clinical trials.

Scientific method in medicine

Scientific equations of therapy

VI. Home Assignment

1. Industrial 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- C. B. Gupta (20) A first course in Mathematical Statistics- C. E. Weatherborn (21) Introduction to Biostatistics-Mahajan

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M.Pharm. Syllabus



(Elective) Subject code: MPHE-102

Subject : Drug Regulatory Affairs (DRA) (TH) (4 Credits)

----------------------------------------------------------------------------------------------------- 1. Aims, objects and salient features of following legislations affecting

pharmaceutical industry. (5 hrs)

Industrial Development and Regulation Act 1951.

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)

Protection of patients and trademarks and design and copy rights and patent system in India. Present status of IPR future changes expected in Indian patents. What may be patented Who may apply for patent Preparation of patent proposal Registration of patent in India and foreign countries and vice versa ICH guidelines for clinical trials, therapeutic drugs monitoring drugs and bioequivalence. Exclusive marketing rights Black box IPR and IDMA views on patents Human health and patent laws latent lethality Indian patent act and copyright (Indian act)

8. Drug and Cosmetics Act 1940 (8 hrs) 9. Prevention of Food Adulteration Act 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 prospective by P. G. Willing and F.T.S. Tse.

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M.Pharm. Syllabus




Subject : Pharmacovigilance & Pharmacoepidemiology (TH) (4 Credits)

------------------------------------------------------------------------------------------------- --

1: Introduction to Pharmacovigilance:

Introduction, Definition, requirement of Pharmacovigilance needed, Objectives of

Pharmacovigilance, Agencies concerned with Pharmacovigilance, Reporting ADRs,

and changes to recommendations for use, Methods involved in

Pharmacovigilance, Pharmacovigilance plans, Scope of Pharmacovigilance, Indian scenario,

Pharmacovigilance and pharmacogenomics

2: Safety monitoring process & good Pharmacovigilance Practices (GPP):

The Monitoring Process, The Role of Institutional Review Boards and Data Safety

Monitoring Boards, Quality Assurance Monitoring, Ending Trials Early: Protecting the

Interests of Participants and the Public.GPP, Overview of Risk Management Goals and

Guidance, Adverse events, serious adverse events, Reporting of AE & SAE,

Pharmacovigilance

3: Good reporting practices and safety signals:

Risk management process, Signals, Case report, Case series, Causality, Data mining,

reporting rates Vs incidence rates, Pharmacovigilance plans, Pharmaco-

epidemiologic safety studies

4: Pharmacoepidemiology, Registers, Surveys:

Pharmacoepidemiology, Guidelines for Good Pharmacoepidemiology Practices (GPP),

Pharmacovigilance Methods, Use of health care databases in

pharmacoepidemiology, Registries, Surveys, Pharmacoeconomics and

pharmacoepidemiology, Pharmacoepidemiology and pharmacokinetics,

International drug monitoring, Using eHealth information for comprehensive

Pharmacovigilance surveillance, Pharmacoepidemiology in India,

Pharmacovigilance and India

References:

1. Textbook of therapeutics Drug and Disease Management: Eric T Herfindel, Dick R.

Gourley, 6th ed.

2. Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision

Making: Janet Woodcock, Frederick Ognibene, John Overbeke.2003; Welly

Publication.

3. Medical Transcription Guide: Do's and Don'ts (Medical Transcription Guide):

Marilyn Takahashi Fordney, Marcy Otis Diehl.

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M.Pharm. Syllabus




Subject : Drug Metabolites (TH) (4 Credits)

--------------------------------------------------------------------------------------------------- 1. Review of drugs metabolism & metabolites. Importance in drug design and discovery,

use of software/ study of current available software

2. Chemical changes / biochemical changes takes place while drugs metabolism along with

chemistry of metabolites.

3. Introduction to metabolite identification in body (urine, serum, organs etc)

a. Various analytical techniques to identify metabolites

b. Chromatography (HPLC, GC), spectroscopic (NMR, MS)

c. Hyphenated (LC-MS, GC-MS) Tandem (MS-MS)

d. Emerging- proteomics, Metabolomic etc

4. Metabolites in disease conditions

Overview of occurrence of drugs / endogenous metabolite during following

disease/disorder conditions along with their physiological/pathological role-

a. Diabetes mellitus

b. Cancer

c. Epilepsy

d. Infectious conditions like bacterial, fungal & viral

e. Cardiovascular disorders

f. Pregnancy, lactation like special condit ions

g. Endogenous metabolites and diseased condition

I. Vitamins (Vit D –cancer, bone health; Vit E-atherosclerosis, etc)

II. Enzymes

III. Hormones

5. Metabolites of imp category of drugs related to above mentioned conditions

6. Metabolites of important phytochemicals like papavarine, nicotine, taxol, isoflavones,

omega 3 fatty acids etc

7. Guidelines for Safety Testing of Drug Metabolites

8. Effect of modification of drugs formulation on occurrence/formation of metabolites

9. Age and genetic related variation in formation of drugs metabolites and its clinical

significance.

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References:

1. Metabolomic in Practice: Successful Strategies to Generate and Analyze ... edited

by Michael Lämmerhofer, Wolfram Weckwerth

2. Guidance for Industry Safety Testing of Drug Metabolites U.S. Department of Health

and Human Services Food and Drug Administration Center for Drug Evaluation

and Research (CDER) February 2008 Pharmacology and Toxicology

3. Guidance for Industry Safety Testing of Drug Metabolites U.S. Department of Health

and Human Services Food and Drug Administration Center for Drug Evaluation

and Research (CDER) February 2008 Pharmacology and Toxicology

4. Identification and Quantification of Drugs, Metabolites and Metabolizing Enzymes

by LC-MS Edited by Swapan Choudhary Hardbound, 354 Pages Published:

November 2005 ISBN 13: 978-0-444-51710-4

5. High Throughput Bioanalytical Sample Preparation By David

Wells Hardbound, 640 Pages Published: January 2003 ISBN 13: 978-0-444-

51029-7

6. Biotransformation and Metabolite Elucidation of Xenobiotics: Characterization

and Identification Ala F. Nassar (Editor) ISBN: 978-0-470-50478-9 328 pages

November 2010 Copyright © 2000-2014 by John Wiley & Sons, Inc., or related

companies. All rights reserved.

7. Reactive Drug Metabolites, Volume 55, Amit Kalgutkar, Deepak Dalvie, R. Scott

Obach, Douglas A. Smith, Raimund Mannhold (Series Editor), Hugo Kubinyi (Series

Editor), Gerd Folkers (Series Editor) ISBN: 978-3-527-33085-0, 402 pages, October

2012, Copyright © 2000-2014 by John Wiley & Sons, Inc., or related companies.

All rights reserved.

8. Mass Spectral and GC Data of Drugs, Poisons, Pesticides, Pollutants and

Their Metabolites, 4th Edition Hans H. Maurer, Karl Pfleger, Armin A. Weber ISBN:

978-3-527-32992-2 1642 pages August 2011 Copyright © 2000-2014 by John Wiley

& Sons, Inc., or related companies. All rights reserved.

9. Metabolome Analysis: An Introduction Silas G. Villas-Boas, Jens Nielsen,

Jorn Smedsgaard, Michael A. E. Hansen, Ute Roessner-Tunali ISBN: 978-0-471-74344-

6 319 pages February 2007 Copyright © 2000-2014 by John Wiley & Sons, Inc., or

related companies. All rights reserved.

10. All related reference books/ journal articles under Pharmacology, Medicinal

Chemistry, Pharmaceutical Analysis, Pharmacognosy & Phytochemistry etc.

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M.Pharm. Syllabus




Subject : Pharmacoinformatics (TH) (4 Credits)

1. Chemoinformatics: Introduction, molecular structures, representation and manipulation

of 2D and 3D structures, generation of 3D structures visualization techniques, molecular

databases, virtual screening, chemical libraries, molecular descriptors, calculation

of descriptors reflecting physical and chemical properties of molecules,

molecular similarities and complementarities, selection of structurally diverse and

representative sets, molecular properties, solubility partition coefficient, drug like

properties, data analysis, quantitative and qualitative structure activity relationship,

prediction of ADME properties, application of Chemoinformatics in drug research.

2. Programming in C, C++, character manipulation, programming techniques for data

base management and developing database oracle.

3. Programming in database environment, development of databases, relational databases,

information retrieval systems, general search methods, Means-ends analysis, depth

first search, breath first search, optimal search, branch and bound etc. Oracle

database environment.

4. Web based search engines and the details of their search algorithms especially

pertaining to bio-computing.

5. Molecular modeling : Energy minimization, geometry optimization, conformational

analysis, global conformational minima determination, approaches and problems,

bioactive vs. global minimum conformations, automated methods of conformational

search, advantages and limitations of available software, molecular graphics, computer

methodologies behind molecular modeling including artificial intelligence methods.

6. Structure activity relationships in drug design: qualitative vs. quantitative approaches,

advantages and disadvantages, random screening, nonrandom screening, drug

metabolism studies, clinical observations, rational approaches to lead discovery,

homologation, chain branching, ring chain transformations, bio-isosterism, insights

into molecular recognition phenomenon, structure based drug design, ligand based

drug design.

7. QSAR: Electronic effects, Hammett equations, lipophilicity effects, Hansch equation,

steric effects, Taft equation, experimental and theoretical approaches for determination of

physicochemical parameters, parameter inter-dependence, case studies, regression

analysis, extrapolation vs. interpolation, linearity vs. non linearity, importance of

biological data in the correct form, 3D-QSAR –example CoMFA and CoMSIA

References:

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Westhead, D.R, Parish, J.H. and Twyman, R. M., Instant notes in bio informatics, BIOS

scientific publishers, 2002. (ISBN. 1859962726)

Attwood, T.K. and parry-smith, D.J., Introduction to bioinformatics, Addison-Wesney-

Longman Ltd. 1999 (ISBN 0582327881)

Baxevanis, A.D. and Ouellette, B.F.F., Bioinformatics; A practical guide to the analysis of genes and proteins, John Wiley, 1998 (ISBN 047119196)

Mount, D.W, Bioinformatics: Sequence and genome analysis, cold spring harbor

laboratory press. (ISBN 0879695978)

Lesk, A.M., Introduction to bioinformatics, 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 press, 1998.

(ISBN 0521629713)

Baldi, P. and Brunak, S., Bioinformatics: The machine learning approach, MIT, 1998

(ISBN 026202442X.)

Brandon, C.I. and Tooze J., Introduction to protein structure, Garland pub., 1991. (ISBN

0815302703)

Lesk, A.M., Introduction to protein architecture: The structural biology of proteins, Oxford University press 2001. (ISBN 0198504748)

Creighton, T.E., Protein Structure: A practical approach. Irl. Pr., 1997. (ISBN

0199636184)

Schultz, G.E., Principles of protein structure, Springer Verlag, 1978 (ISBN:

0387903348)

Sternberg, M (Ed), Protein structure prediction- A practical approach, Oxford university

press, London 1996.

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SEMESTER-II

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M.Pharm. Syllabus

M. Pharm. (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; Advantages 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-

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, Applications of Polymers in formulation of controlled drug delivery

systems, Biodegradable and Nonbiodegradable polymers, Properties of following commonly used

polymers- Starch, Gelatin, Chitosan, Albumin, Cellulose derivatives and Poloxamers.

3. TRANSDERMAL DRUG DELIVERY SYSTEMS 6 Hours

Permeation through skin, Factors affecting permeation, Basic components of TDDS, 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, Advantages and Disadvantages, Structure of oral

mucosa, Trans-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, 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

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Concepts, Advantages 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 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 (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 / 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

Delhi, First edition, 2002.

4. Remington’s 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. Bentley’s Textbook of Pharmaceutics; By E.A.Rawline, ELBS Publications.

10. Microencapsulation and Related Drug Process; By Patric B.Deasy.

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M.Pharm. Syllabus




Subject: 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-Chemical and Pharmaceutical dosage

form factors; Methods of determining 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, Volume of distribution,

3. PROTEIN BINDING 3 Hours

Plasma protein binding: factors affecting, significance and kinetics of protein binding.

4. METABOLISM OF DRUGS 5 Hours

Definition, brief overview of Phase I (Oxidative, reductive and hydrolytic reactions) and Phase II reactions

(Conjugation) of Biotransformation. Factors affecting biotransformation.

5. EXCRETION OF DRUGS 5 Hours

Definition, Renal and non-renal excretion, Concept of clearance - Renal clearance, Organ clearance &

Hepatic clearance.

6. BASIC CONCEPTS OF PHARMACOKINETICS 14 Hours

Basic considerations, Pharmacokinetic models, Compartment modeling: one compartment model - IV

bolus, IV infusion, Extra-vascular; Multi Compartment models; Two compartment model - IV bolus, IV

infusion, Extra-vascular, Three Compartment model in brief.

7. NON-LINEAR PHARMACOKINETICS 4 Hours

Cause of non-linearity, Michaelis-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. Remington’s Pharmaceutical Sciences; By Mack publishing company, Pennsylvania.

3. Pharmacokinetics; By Milo Gibaldi, Donald Perrier; Marcel Dekker, Inc.

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4. Handbook of clinical Pharmacokinetics; 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- A Treatise; By D.M.Brahmankar and Sunil B.Jaiswal., 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 Publishing Company,

Pennsylvania, 1989.

10. Biopharmaceutics and Clinical 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 13, James Swarbrick, James. C.Boylan. Marcel

Dekker Inc, New York, 1996.

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M.Pharm. Syllabus




Subject: Advanced Pharmaceutics & Cosmeticology (4 Credits)

---------------------------------------------------------------------------------------------------------------------- 1. STERILIZATION PROCESS 8 Hours

Principle, Advantages, Disadvantages, Applications of different sterilization methods, equipments.

Sterility testing: Principle, general 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 STUDIES 9 Hours

Definition, Objective of bioavailability, Parameters of bioavailability, Determination of AUC. Estimating

absorption rate of drugs; Measurement of bioavailability- Pharmacokinetic methods and

Pharmacodynamic methods. Drug dissolution rate & 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 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, foam, aerosol

cosmetics and their Performance, physicochemical and microbiological 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.

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4. Advances in Pharmaceutical Sciences Vol. 1-5; By H.S. Bean & A.H. Beckett.

5. Physical Pharmacy; By Alfred martin

6. Bentley’s Textbook of Pharmaceutics – Rawbins.

7. Pharmaceutical Preformulations; By J.J. Wells.

8. Harry’s Cosmeticology.

9. Textbook of Cosmeticology by B.M.Mittial.

10. Textbook of Cosmeticology by P.P.Sharma.

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M.Pharm. Syllabus




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 polymer membranes.

3. Study on In-vitro dissolution of various sustained release formulations of

marketed products.

4. Preparation of matrix tablets using various polymers, like polyvinyl 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 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 dispersion 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, 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

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M.Pharm. Syllabus




Subject: Laboratory Course 4 08 hr / wk (4 Credits)

----------------------------------------------------------------------------------------------------------------------- 1. Pre-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 and 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 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 topics.

RECOMMENDED BOOKS:

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

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M.Pharm. Syllabus

M. Pharm. (Semester – II) PHARMACEUTICAL CHEMISTRY



Subject: 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 active compounds,

conformations in cyclic compounds, optical isomerism, shapes of cyclohexanes and 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-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-

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

Green Chemistry

Allylic bromination, ozonolysis, free radical reactions, use of diazomethane and peracids in

synthesis

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 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

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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- Peterskyes Orient Longman, New Delhi.

8. Reactive intermediates in Organic chemistry- Tandom and Gowel.

9. Molecular reaction and 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- by Eliel

14. Text Book of Organic chemistry – by Morrison and Boyd

15. Text Book of Organic chemistry – by S. K. Ghosh

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M.Pharm. Syllabus




Subject: 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 Alzheimer’s 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, Citrenalol, propanolol

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6. PRODRUG DESIGN 6 hrs

Introduction, chemical bond, gastrointestinal absorption, parenteral administration, distribution,

transdermal absorption, pharmacokinetics and biopharmaceutical aspects, rational of prodrug design and

practical considerations

HOME ASSIGNMENT

Recent advances and trends 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 I-IV, Academic Press.

8. Combinational 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

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M.Pharm. Syllabus




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 of QSAR

b. Drug-Receptor Interactions

c. Quantitative model parameters: lipophilicity, electronic and steric factors

d. Hansch Analysis, Free Wilson analysis, relationship between them and their application.

e. Statistical methods-regression analysis, partial-least square analysis (PLS) and other

multivariate statistical methods

f. 2D and 3D QSAR approaches

5. MOLECULAR MODELING 20 hrs

a. introduction to Molecular Modeling- concepts and methods

b. Molecular mechanics-Force 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-Steepest, desent, conjugate gradients, Newton methods (Non

mathematical)

g. Conformational Analysis

i) Systematic search

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ii) Monte Carlo Simulations

iii) Molecular Dynamics Simulations

h. Ligand design based on 3D structure

HOME ASSIGNMENT

Study of software for QSAR, Docking, Molecular modeling and protein 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 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

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M.Pharm. Syllabus




Subject: Laboratory Course 3 08 hrs / wk (4 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 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 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)

3. 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.

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M.Pharm. Syllabus





-----------------------------------------------------------------------------------------------------------------------

1. Synthesis of drugs mentioned in the theory using basic operations like molecular distillation,

fractional crystallization and purification 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 chromatographic 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 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

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M.Pharm. Syllabus

M. Pharm. (Semester – 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 (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 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 & revalidation, 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.

3. J.R. Berry and R.A. Nash, Pharmaceutical process validation. Marcel and Dekker.

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4. S.H. Will and J.R. Stoker, good manufacturing Practices for Pharmaceutics Marcel Dekker. 5. R.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 Sciences. Marcel,Dekker. 11. DeSpautz.J.F.’Automation and Validation of information in Pharmaceutical Processing’ Marcel

Dekker, New York.

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M.Pharm. Syllabus




Subject: 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 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

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 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; 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, Dekker.

g. A. Martin, P. Bustamante and A. H. Chun; Physical Pharmacy; Waverly.

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 product development, CBS publishers and distributors.

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p. K. E. Avis, H. A. Liberman and Lanchman; Pharmaceutical dosage forms: Parenteral Medications: Vol.

1, 2, 3, Marcel Dekker.

q. Remington’s Pharmaceutical Sciences by Osol

r. Lachman, Theory & Practice of Industrial Pharmacy

s. Cartensens , Pharmaceutics of Solids and Solid dosage form

t. bean & Beckett, Advance in Pharm. Sciences

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M.Pharm. Syllabus




Subject: Quality Management (4 Credits)

1. Concept of Total Quality Management, Philosophy of GMP’S 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 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 Procedure, Quality audits of manufacturing processes and

facilities.

7. In-process quality controls on various dosage forms sterile and nonsterile. Standard Operation

Producers for various operation like cleaning, filling, drying compression, coating, 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 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, 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-1990

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M.Pharm. Syllabus





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 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 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 factorial design.

11. Design of experiments based on theory topics.

RECOMMENDED BOOKS:


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M.Pharm. Syllabus





1. Calibration of analytical instruments like 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 of active constituents from crude drugs.

6. Quality control tests for some herbal formulation

7. Phase solubility analysis

8. Determination of α-amino acid using pH meter

9. Assay of API in sample using HPTLC/HPLC

10. Determination of λmax 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:


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M.Pharm. Syllabus

M. Pharm. (Semester – II) PHARMACOLOGY



Subject: 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 various diseases.

3. Transgenic mouse and its applications. Human genome mapping and its potential in

drug research.

4. Endogenous bioactive molecules as TNF-α, Interleukins, process of apoptosis,

arachidonic acid metabolites, COX-2 regulators and their role in inflammation.

Endothelium derived vascular substances such as NO, endothelins and their

modulators.

5. Molecular Mechanism of drug action: Receptor occupancy and cellular signaling

system such as G-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

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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, Philadelphia.

7. Harrisons Principles of Internal Medicine, McGraw Hill.

8. Davidson’s Principles and Practice of Medicine, 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, 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

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M.Pharm. Syllabus




Subject: 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. Bioavailability and Bioequivalence: Principles, objectives, protocols and variation of

bioavailability & bioequivalence, measurement, designing of bioavailability studies &

interpretation of results, Physiological, physico-chemical & formulation factors affecting

bioavailability, 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-linear pharmacokinetics like saturable enzymatic

process, examples of drugs that follow non-linear 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; 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, Clinical Pharmacokinetics: Conceptand

Application, Lea and 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.

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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

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M.Pharm. Syllabus




Subject: 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 estimation. 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 on T and B lymphocytes, Antibody dependent and

cellular cytotoxicity - Anti-inflammatory

Endocrine system- Hypoglycemics, Anti-thyroid agents

Urinary system- Diuretics

Reproductive system- antifertility agents, androgens

4. Alternatives to animal screening procedure, cell line handling, maintenance and

propagation of cell lines, their uses and limitations, in-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.

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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 Prakashan, 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 Excersise 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.

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M.Pharm. Syllabus





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 Ka, biological half-life, AUC and other pharmacokinetic parameters

of drug/s by urinary excretion method.

4. Calculation of various pharmacokinetic parameters after an IV bolus dose

5. To determine protein-binding of drugs.

6. To study the influence of urinary pH on drug excretion.

7. Calculation of Ka, K

e, t

½, C

max and T

max from the given data.

8. Calculation of AUC and bioequivalence from the given data

9. Experiment based on bio-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-acute

toxicity study of test drugs.

12. Statistical evaluation of given data/s and finding level of significance.

13. Hand on experience on online/offline/open source statistical and pharmacokinetic

softwares.

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M.Pharm. Syllabus





*Module-1 is compulsory. From module-2 to 5 any ten practicals 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, 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 values of various parameters

3. Handling and drug 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 Eddy’s hot plate /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 chemically and

electrically induced convulsions in rats.

5. To study effect of Pentobarbitone sodium on righting reflex in mice.

6. To study Anti-anxiety effect of diazepam in mice using elevated plus maze

apparatus/ Irwin’s method/ Elevated plus maze/ Water maze/ Zero maze.

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.

Module-3: Bioassays of drugs (03)

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To study DRC, CRC, potency andbioassays of agonist and antagonist (e.g. Ach, Histamine,

oxytocin, Pancuranium, 5-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 (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 using 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 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.

Module-5: Invasive/ In-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.

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M.Pharm. Syllabus

M. Pharm. (Semester – II) PHARMACEUTICS / PHARMACEUTICAL CHEMISTRY / PHARMACOLOGY

/ QUALITY ASSURANCE

(Elective Subject)

Subject code: MPHE - 206

Subject: Industrial Pharmacy (4 Credits)

1. PREFORMULATION 10 Hours

Introduction, organoleptic properties, purity, particle size, shape, and surface area. Solubilisation,

surfactants and its importance, temperature, pH, co-solvency; Techniques for the study of crystal

properties and polymorphism. Physicochemical characteristics of new drug molecules with 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- 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 tablets, capsules, injections,

liquid orals, semisolids, ophthalmic products, emulsions including multiple emulsions.

5. METHODS OF ENHANCING BIOAVAILABILITY 7 Hours

Solubilization, Prodrugs, and enhancement of dissolution characteristics, cyclodextrin, permeation

enhancer, solid dispersion, surfactant, bioavailability enhancers.

6. SURFACTANT SYSTEM 7 Hours

Introduction, micellization, thermodynamics and kinetics of micelle formation, classification.,.

Pharmaceutical aspects of Solubilization, Solubilization in non-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- 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. 1-3 by Leon Lachmann.

3. Pharmaceutical Dosage forms: Disperse systems, Vol, 1-2; By Leon Lachmann.

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4. Pharmaceutical Dosage forms: Parenteral medications Vol. 1-2; Leon Lachmann.

5. Modern Pharmaceutics; By Gillbert and S. Banker.


7. Advances in Pharmaceutical Sciences Vol. 1-5; By H.S. Bean & A.H. Beckett.

8. Physical Pharmacy; By Alfred martin

9. Bentley’s 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.

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M.Pharm. Syllabus

M. Pharm. (Semester – II) PHARMACEUTICS / PHARMACEUTICAL CHEMISTRY / PHARMACOLOGY /

QUALITY ASSURANCE

(Elective Subject)


Subject: Natural Products (4 Credits)

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, vincristine, 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. ß- Lactum Antibiotics

Mechanism of action, penicillins, cephalosporins, nocardicilins and monobactums, carbopenams

and penams, β- Lactamaseinhibitors and other ß -Lactum agents

b. Non ß –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.

Diabetic Therepy- Gymnes sylvestre, salacia reticulate, pterocarpus marsupiam, swertia, chirata,

trigonella, foenum-graccum

Liver Disfunction- phyllanthus niruri

Antitumor- curcuma longa linn, taxol, teniposide, etoposide.

REFERENCES

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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 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 Vol 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

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M.Pharm. Syllabus


/ QUALITY ASSURANCE

(Elective Subject)


Subject: Biological Evaluation (4 Credits)

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 of some

official drugs

6. Radioimmunoassay: General principles, 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; Walker Edwards, Churchill Livingston

6. Analysis drug treatment

7. Bontempo J.A.,’ development of Bio-Pharmaceutical Parenteral Dosage Forms’ Marcel Dekker,

Nerw York.

8. Kamalesh Kohli, Clinical Pharmacotherapecutics, edited by, Elsevier Publication.

9. J.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.

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M.Pharm. Syllabus


/ QUALITY ASSURANCE

(Elective Subject)


Subject: Clinical Pharmacology & Toxicology (4 Credits)

1. Introduction to clinical pharmacology, importance of clinical pharmacokinetics,

therapeutic-monitoring of drugs.

2. Organization, types of clinical research; design and organization of phase-I to IV of

clinical studies, ethics of clinical trials.

3. Drug-drug, drug-food, drug-pollutants interactions.

4. Principles of pediatric, geriatric pharmacology; drug therapy in pregnancy and

lactation.

5. Neuropharmacology: Clinical aspects of drug therapy of Epilepsy, Parkinson’s

disease, migraine, myasthenia gravis and Alzheimer’s 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.

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 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 Therapeutics, Mc Graw Hill

of 66

2.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: Basic 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 Medicine, McGraw Hill.

8. Davidson’s 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, Churchill Livingston, UK

12. Crossland Lewis’s 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, 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 Pharmacological 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.

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M.Pharm. Syllabus


/ QUALITY ASSURANCE

(Elective Subject)


Subject: Pharmaceuticals Stability Studies (4 Credits)

Stability aspects: Basic concept and objectives of stability study.

• Regulatory requirement for stability studies: A very brief introduction to FDA and

WHO guidelines. Detail study of ICH guidelines [Q1A (R2), Q1B, Q1C, Q1D, Q1E,

Q1F, Q5C].

• Kinetic principles applied for stability evaluation and their applications in

predicting shelf life and half life of pharmaceutical formulations. Importance of

accelerated stability study.

• Degradation pathways (Degradation by hydrolytic, oxidative, reductive,

photolytic, etc) and stabilization methods for formulation.

• Stability indicating assays and its importance

Stability testing and dating of solid and liquid dosage forms: • Different approaches for stability testing of solid and liquids, kinetic

principles, physical and chemical stability testing of pharmaceutical dosage forms and packages.

Product life-cycle management

Product liability and compensation

Stability issues related to proteins and insulin type formulations

Stability issues related to herbal formulations, extracts, fractions and

natural products/isolated compounds.

Stability issues for vaccines and biological products

REFERENCES:

1. Drug Stability, J.T. Carstensen, Marcel Dekker, New York. 2 . Chemical Stability of Pharmaceuticals-A Handbook for Pharmacists, Kenneth Connors,

John Wiley and Sons, Inc. 3. Good Drug Regulatory Practices: a Regulatory Affairs Quality Manual (Good Drug

Development Series) – Helene I. Dumit 4. United States Pharmacopoeia-27(NF-22), United State of Pharmacoppeal convention,

INC, 12601 Twinbrook Parkway, Rockville, MD 20852. 5. The International Pharmacopoeia Vol. 1,2,3,4, General methods of analysis and quality

specifications for pharmaceutical substances, excipients, dosage forms. 6. Phytochemical Methods, J.B.Harborne, Chapman and Hall, London and New York. 7. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian

Medicine and Homeopathy).

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M.Pharm. Syllabus


/ QUALITY ASSURANCE

(Elective Subject)


Subject: Quality Assurance Approach & Improvement (4 Credits)

Quality improvement process

Quality in research and development

Complaints and recalls: evaluation of complaints, recall procedure, related

records and documents.

Quality control laboratory – responsibilities and laboratory practices. Routine

controls on instruments, reagents, sampling plans, standard test procedures and

protocols, control on animal house, data generation and storage, quality control

documentation and audits of QC facilities.

Finished product release, quality review, quality audits and batch release

documents. Validation and security measures for electronic data and computer

assisted process. Calibration and validation of master plan

Cosmetics, biotechnological, microbiological products & regulations, medical

device regulations; fraud and professional misconduct

REFERENCES:

1. Encyclopedia of Pharmaceutical Technology Vol.1-3, Swarbric, J and Bolyln, J. C., Marcel Dekker, Inc., New York.

2. United States Pharmacopoeia-27(NF-22), 2004, United State of Pharmacoppeal convention, INC, 12601 Twinbrook Parkway, Rockville, MD 20852.

3. The International Pharmacopoeia Vol. 1,2,3,4, General methods of analysis and quality specifications for pharmaceutical substances, excipients, dosage forms.

4. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian Medicine and Homeopathy).

5. Juran’s Quality Handbook, 5th Ed, by J M Juran, A B Godfrey, McGrawHill International Edition

6. Official books like IP, BP, USP, etc of recent editions

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M.Pharm. Syllabus


/ QUALITY ASSURANCE

(Elective Subject)


Subject: Sterile Products Formulation & Technology (4 Credits)

1. Biopharmaceutical Factors Influencing Bioavailability: Physicochemical influences

on bioavailability, Physiologic factors influencing drug absorption, Dosage form

considerations, Drug absorption and bioavailability from intramuscular injection. Drug

absorption from subcutaneous injection, Biopharmaceutics of intrathecal injections,

parenteral administration of peptides and proteins, Parenteral drug delivery systems.

2. Preformulation Research: Introduction, Drug substance physicochemical properties,

General modes of drug degradation, Preformulation studies for proteins and peptides,

Preformulation screening of parenterals packaging components.

3. SVP and LVP: Introduction to SVP, Formulation principle, Special types of Parenteral

(Suspension, Emulsion, Dried Forms), Container effect on formulation, Stability evaluation.

Introduction to LVP, Concept of formulation, Formulation development, Solution Quality.

4. Sustained/Controlled Release Parenterals Drug products:

Biopharmaceuti

cs, Biocompability of polymeric materials, Sustained/controlled release dosage forms: -

Aqueous solutions, Aqueous suspensions, O il solutions, Oil suspensions,

Biocompatible carrier, Liposomes, Nanoparticles, Infusion devices, Prodrug.

5. Design Consideration For Parenteral Production Facility: Introduction, Site selection, Facility area use planning, Design concepts.

6. Environmental control: Introduction, Control of contamination,

Environmental contamination control system design, Clean rooms, Personnel contamination

control.

7. Quality Control: Sterility testing, FDA guidelines on sterility testing, Pyrogen

testing, Particulate matter testing, and Package integrity testing.

References:

1. K. E. Avis, H. A. Liebermann and Lachman; Pharmaceutical dosage forms:

Parenteral Medications: Vol.1, 2, 3, Marcel Dekker.

2. S. J. Turco Sterile Dosage Forms: their preparation and clinical application; 4th Edition.

Lee and Febiger.

3. N. K. Jain; Controlled and Novel drug delivery: CBS Publication.

4. J. R. Robinson and H. L. Lee; Controlled drugs delivery: Fundamentals and

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Applications; Marcel Dekker.

. 5 . S.P. Vyas and R. K. Khar, Controlled drug delivery: concepts and advances;

Vallabh Prakashan.

6. M. J. Akers, Parenteral Quality Control. Third Edition. Marcel Dekkers.

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M.Pharm. Syllabus


/ QUALITY ASSURANCE

(Elective Subject)


Subject: Biomaterials for Drug Delivery (4 Credits)

1. Biomaterials: Introduction, classification, mechanical, surface, electrochemical,

& physiochemical properties of biomaterials: metallic, ceramic, polymeric,

composite, biodegradable hydrogels, and biologic biomaterials.

2. Biodegradable polymers: Mechanisms of polymer degradation, factors

affecting biodegradability, various methods to study biodegradability: enzyme

assays, plate tests, respiration tests, gas (CO2 or CH4) evolution tests,

radioactively labeled polymers. Study of segmented co-polyesters with

prolonged strength retention profiles, polyaxial crystalline fiber forming co-

polyester, polyethylene glycol-based co-polyesters, cyanoacrylate-based systems

as tissue adhesives, chitosan-based systems.

3. Development and applications of new systems: Fabrication of crystalline fiber-

forming aliphatic copolyesters, medical absorbable devices, tissue engineering

systems, synthetic vascular constructs, implantable insulin controlled release

systems, absorbable delivery systems, tumor immunotherapeutic systems.

4. Testing of biomaterials: Biocompatibility, blood compatibility and tissue

compatibility of biomaterials. In-vitro and in-vivo testing of toxicity, sensitization,

carcinogenicity, mutagenicity testing of biomaterials.

5. Regulatory aspects of biomaterials: Regulatory aspects of biomaterials and their

approval status in various countries. Toxicity and interaction of biomaterials with

body components.

References:

1. Sujata V. Bhatt, Biomaterials, Springer, 2002.

2. Buddy D. Ratner, Fredrick J. Schoen, Allan S. Hoffman, and Jack E. Lemons

“Biomaterials Science: An introduction to Materials in medicine, Academic Press, 2004.

3. Jonathan Black, Biological Performance of materials, Taylor & Francis,2006

4. C.P.Sharma & M.Szycher, Blood compatible materials and devices, Technomic Publishing

Co. Ltd., 1991.

5. Piskin & A.S Hoffmann, Polymeric Biomaterials (Eds), Martinus Nijhoff Publishers,

1986 6. J. B. Park, Biomaterials - Science and Engineering, Plenum Press, 1984.

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M.Pharm. Syllabus

M. Pharm. (Semester – II)

PHARMACEUTICS / PHARMACEUTICAL CHEMISTRY / PHARMACOLOGY /

QUALITY ASSURANCE

(Elective Subject)


Subject: Polymers in Pharmaceutics (4 Credits)

1. Classification of polymers, synthesis of polymers, general methods of preparation

of polymers like solution bulk, suspension and emulsion polymerizations. Properties

of following commonly used polymers such as Starch, cyclodextrins, chitosan,

gelatin, albumin, Cellulose derivatives, acrylates and poloxamers.

2. Characterization of polymers: Molecular weight and Molecular weight distribution

of polymers, flow characteristics, crystallinity, solubility and thermodynamics of

polymers solutions, biodegradability and biocompatibility testing of polymers.

3. Factors affecting selection of polymers, Effect of additives on polymer properties, Effect

of environmental conditions on polymer properties, Polymer properties influencing

drug permeation, Factors influencing kinetics of solute release.

4. Natural & Synthetic Acrylates and their applications

5. Biodegradable polymers and their application in pharmaceuticals

6. Application of polymers in sustained & controlled release drug delivery system (

Oral, Mucosal, Transdermal)

7. Applications of polymers in new drug delivery systems.

References:

1. J. Brandrup, E.H. Immergur; Polymer Handbook; John Wiley and Sons.

2. Charles G. Gebelein, T.C. Chin and V. C. Yang; Cosmetic and Pharmaceutical Applications

of Polymers; Plenum Press, New work.

3. D.S. Soane; Polymer Applications of Biotechnology; Prentice Hall Inc.

4. J. R. Robison and V. H. Lee; Controlled Drug delivery- Fundamentals and Applications;

Marcel Dekker.

5. N.K. Jain; Controlled and Novel Drug Delivery; CBS

publication. 6. P. J. Tarcha; Polymers for controlled Drug

Delivery; CRC Press

7. A. F. Kydonieus: Controlled Release Technologies: Methods, Theory and Applications, Vol. I

& II CRC press Inc.

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