Revised Regulations for the

Master of Pharmacy Degree Program

(w.e.f. June 2016)

Credit Based Semester System

Pharmacy Council of India

Combined Council's Building, Kotla Road,
Aiwan-E-Ghalib Marg,
New Delhi-110 002
 Table – 7: Course of study for M. Pharm. (Pharmaceutics)

Course Course Credit Credit Marks

Code Hours Points Hrs./wk
Semester I
MPA101T Modern Pharmaceutical Analytical 4 4 4 100
Techniques
MPH101T Modified Release Drug Delivery 4 4 4 100
System
MPH102T Modern Pharmaceutics 4 4 4 100
MPH103T Pharmaceutical Regulatory Affair 4 4 4 100
MPH104P Pharmaceutics Practical I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MPH201T Molecular Pharmaceutics(Nano 4 4 4 100
Tech and Targeted DDS)
MPH202T Advanced Biopharmaceutics & 4 4 4 100
Pharmacokinetics
MPH203T Computer Aided Drug Delivery 4 4 4 100
System
MPH204T Cosmetic and Cosmeceuticals 4 4 4 100
MPH205P Pharmaceutics Practical I 12 6 12 150
- Seminar/Assignment 7 4 7 100
Total 35 26 35 650

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M. PHARM. PHARMACEUTICS (MPH)

36
 MODERN PHARMACEUTICAL ANALYSIS (MPA101T)

Scope

This subject deals with various advanced analytical instrumental techniques for
identification, characterization and quantification of drugs. Instruments dealt are NMR, Mass
spectrometer, IR, HPLC, GC etc.

Objectives

After completion of course student is able to know,

 The analysis of various drugs in single and combination dosage forms
 Theoretical and practical skills of the instruments

THEORY 60 HOURS

1. UV-Visible spectroscopy: Introduction, Theory, Laws, Instrumentation 11 Hrs

associated with UV-Visible spectroscopy, Choice of solvents and solvent
effect and Applications of UV-Visible spectroscopy.
IR spectroscopy: Theory, Modes of Molecular vibrations, Sample handling,
Instrumentation of Dispersive and Fourier - Transform IR Spectrometer,
Factors affecting vibrational frequencies and Applications of IR spectroscopy
Spectroflourimetry: Theory of Fluorescence, Factors affecting fluorescence,
Quenchers, Instrumentation and Applications of fluorescence
spectrophotometer.
Flame emission spectroscopy and Atomic absorption spectroscopy:
Principle, Instrumentation, Interferences and Applications.

2 NMR spectroscopy: Quantum numbers and their role in NMR, Principle, 11 Hrs
Instrumentation, Solvent requirement in NMR, Relaxation process, NMR
signals in various compounds, Chemical shift, Factors influencing chemical
shift, Spin-Spin coupling, Coupling constant, Nuclear magnetic double
resonance, Brief outline of
principles of FT-NMR and 13C NMR. Applications of NMR spectroscopy.

3 Mass Spectroscopy: Principle, Theory, Instrumentation of Mass 11 Hrs

Spectroscopy, Different types of ionization like electron impact, chemical,
field, FAB and MALDI, APCI, ESI, APPI Analyzers of Quadrupole and
Time of Flight, Mass fragmentation and its rules, Meta stable ions, Isotopic
peaks and Applications of Mass spectroscopy

37
4 Chromatography: Principle, apparatus, instrumentation, chromatographic 11 Hrs
parameters, factors affecting resolution and applications of the following:
a) Paper chromatography b) Thin Layer chromatography
c) Ion exchange chromatography d) Column chromatography
e) Gas chromatography f) High Performance Liquid chromatography
g) Affinity chromatography

5 Electrophoresis: Principle, Instrumentation, Working conditions, factors 11 Hrs

affecting separation and applications of the following:
a) Paper electrophoresis b) Gel electrophoresis c) Capillary electrophoresis d)
Zone electrophoresis e) Moving boundary electrophoresis f) Iso electric
focusing
X ray Crystallography: Production of X rays, Different X ray methods,
Bragg‘s law, Rotating crystal technique, X ray powder technique, Types of
crystals and applications of X-ray diffraction.

6 Immunological assays : RIA (Radio immuno assay), ELISA, 5 Hrs

Bioluminescence assays.

REFERENCES
1. Spectrometric Identification of Organic compounds - Robert M Silverstein, Sixth edition,
John Wiley & Sons, 2004.
2. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler, Timothy A.
Nieman, 5th edition, Eastern press, Bangalore, 1998.
3. Instrumental methods of analysis – Willards, 7th edition, CBS publishers.
4. Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4th edition, CBS
Publishers, New Delhi, 1997.
5. Organic Spectroscopy - William Kemp, 3rd edition, ELBS, 1991.
6. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi, 3rd Edition, CBS
Publishers, New Delhi, 1997.
7. Pharmaceutical Analysis- Modern methods – Part B - J W Munson, Volume 11, Marcel
Dekker Series

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 DRUG DELIVERY SYSTEM (MPH101T)

SCOPE
This course is designed to impart knowledge on the area of advances in novel drug
delivery systems.

OBJECTIVES

Upon completion of the course, student shall be able to understand

 The various approaches for development of novel drug delivery systems.
 The criteria for selection of drugs and polymers for the development of
 The formulation and evaluation of Novel drug delivery systems..

THEORY 60 Hrs
10 Hrs
1. SR/CR formulation: Introduction & basic concepts, advantages/ disadvantages,
factors influencing, Physicochemical & biological approaches for SR/CR
formulation, Mechanism of Drug Delivery from SR/CR formulation. Polymers
:introduction, definition, classification, properties and application Dosage Forms
for Personalized Medicine: Introduction, Definition, Pharmacogenetics, Categories
of Patients for Personalized Medicines: Customized drug delivery
systems,Bioelectronic Medicines,3D printing of pharmaceuticals, Telepharmacy.
10 Hrs
2. Rate Controlled Drug Delivery Systems: Principles & Fundamentals, Types,
Activation; Modulated Drug Delivery Systems;Mechanically activated, PH
activated , Enzyme activated, and Osmotic activated Drug Delivery
Systems Feedback regulated Drug Delivery Systems; Principles & Fundamentals

.
3. Gastro-Retentive Drug Delivery Systems: Principle, concepts advantages and
disadvantages, Modulation of GI transit time approaches to extend GI transit.
Buccal Drug Delivery Systems: Principle of muco adhesion, advantages and
disadvantages, Mechanism of drug permeation,Methods of formulation and its
evaluations.
10 Hrs
4. Occular Drug Delivery Systems: Barriers of drug permeation, Methods to
overcome barriers.
6 Hrs
5. Trans Dermal Drug Delivery Systems: Structure of skin and barriers, Penetration
enhancers, Transdermal Drug Delivery Systems, Formulation and evaluation
10 Hrs
6. Protein and Peptide Delivery: Barriers for protein delivery. Formulation and
Evaluation of delivery systems of proteins and other macromolecules.

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 8 Hrs
7. Vaccine delivery systems: Vaccines, uptake of antigens, single shot vaccines,
mucosal and transdermal delivery of vaccines.
6 Hrs

REFERENCES
1. Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and expanded,
Marcel Dekker, Inc., New York, 1992.
2. Robinson, J. R., Lee V. H. L, Controlled Drug Delivery Systems, Marcel
Dekker,Inc., New York, 1992.
3. Encyclopedia of controlled delivery, Editor- Edith Mathiowitz, Published by
WileyInterscience Publication, John Wiley and Sons, Inc, New York!
Chichester/Weinheim
4. N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers & Distributors,
New Delhi, First edition 1997 (reprint in 2001).
5. S.P.Vyas and R.K.Khar, Controlled Drug Delivery - concepts and advances,
Vallabh Prakashan, New Delhi, First edition 2002

JOURNALS
1. Indian Journal of Pharmaceutical Sciences (IPA)
2. Indian drugs (IDMA)
3. Journal of controlled release (Elsevier Sciences) desirable
4. Drug Development and Industrial Pharmacy (Marcel & Decker) desirable

40
 MODERN PHARMACEUTICS (MPH102T)

Scope
Course designed to impart advanced knowledge and skills required to learn various
aspects and concepts at pharmaceutical industries

Objectives
Upon completion of the course, student shall be able to understand
 To understand the elements of preformulation studies.
 To understand the Active Pharmaceutical Ingredients and Generic drug Product
development
 To learn Industrial Management and GMP Considerations.
 To understand Optimization Techniques & Pilot Plant Scale Up Techniques
 To study Stability Testing, sterilization process & packaging of dosage forms.

THEORY
60 HRS

10 hrs
1. Preformation Concepts – Drug Excipient interactions - different methods,
kinetics of stability, Stability testing.
Theories of dispersion and pharmaceutical Dispersion (Emulsion and Suspension,
SMEDDS) preparation and stability
Large and small volume parental – physiological and formulation consideration,
Manufacturing and evaluation
10 Hrs
2. Optimization techniques in Pharmaceutical Formulation: Concept and
parameters of optimization, Optimization techniques in pharmaceutical formulation
and processing. Statistical design, Response surface method, Contour designs,
Factorial designs and application in formulation.

10 Hrs
3. Validation : Introduction to Pharmaceutical Validation, Scope & merits of
Validation, , Validation and calibration of Master plan, ICH & WHO guidelines for
calibration and validation of equipments, Validation of specific dosage form, Types
of validation. Government regulation, Manufacturing Process Model, URS, DQ, IQ,
OQ & P.Q. of facilities

10 Hrs
4. cGMP & Industrial Management: Objectives and policies of current good
manufacturing practices, layout of buildings, services, equipments and their
maintenance Production management: Production organization, , materials

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 management, handling and transportation, inventory management and control,
production and planning control, Sales forecasting, budget and cost control,
industrial and personal relationship. Concept of Total Quality Management

10 Hrs
5. Compression and compaction: Physics of tablet compression, compression,
consolidation, effect of friction, distribution of forces, compaction profiles.
Solubility enhancement techniques.
10 Hrs
6. Study of consolidation parameters; Diffusion parameters, Dissolution parameters
and Pharmacokinetic parameters, Heckal plats, Similarity factors – f2 and f1,
Higuchi and peppas plot, Linearity Concept of significance, Standard deviation , chi
square test , student T-test , Anova test.

REFERENCES
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.
4. Pharmaceutical Dosage forms: Parenteral medications Vol. 1-2; By Leon Lachmann.
5. Modern Pharmaceutics; By Gillbert and S. Banker.
6. Remington’s Pharmaceutical Sciences.
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. Quality Assurance Guide; By Organization of Pharmaceutical producers of India.
12. Drug formulation manual; By D.P.S. Kohli and D.H.Shah. Eastern publishers, New
Delhi.
13. How to practice GMPs; By P.P.Sharma. Vandhana Publications, Agra.
14. Pharmaceutical Process Validation; By Fra. R. Berry and Robert A. Nash.
15. Pharmaceutical Preformulations; By J.J. Wells.
16. Applied production and operations management; By Evans, Anderson, Sweeney and
Williams.

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 REGULATORY AFFAIRS (MPH103T)

Scope

Course designed to impart advanced knowledge and skills required to learn the
concept of generic drug and their development, various regulatory filings in different
countries, different phases of clinical trials an submitting regulatory documents
filing process of IND, NDA and ANDA
 To know the approval process of
 To know the chemistry, manufacturing controls and their regulatory importance
 To learn the documentation requirements for
 To learn the importance and

Objectives:

Upon completion of the course, it is expected that the students will be able to understand

 The Concepts of innovator and generic drugs, drug development process

 The Regulatory guidance’s and guidelines for filing and approval process
 Preparation of Dossiers and their submission to regulatory agencies in different
countries
 Post approval regulatory requirements for actives and drug products
 Submission of global documents in CTD/ eCTD formats
 Clinical trials requirements for approvals for conducting clinical trials
 Pharmacovigilence and process of monitoring in clinical trials.

THEORY
60 Hr

1. Documentation in pharmaceutical industry: Master formula record, DMF (Drug

Master File), distribution records. Generic drugs product development Introduction
, Hatch- Waxman act and amendments , CFR (CODE OF FEDERAL
REGULATION) ,drug product performance, in-vitro ,ANDA regulatory approval
process, NDA approval process, BE and drug product assessment, in –vivo, scale
up process approval changes, post marketing surveillance, outsourcing BA and BE
to CRO

1
2 hrs
2. Regulatory requirement for product approval: API, biologics, novel, therapies
obtaining NDA, ANDA for generic drugs ways and means of US registration for
foreign drugs
12 hrs

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 3. CMC, post approval regulatory affairs.Regulation for combination products and
medical devices.CTD and ECTD format, industry and FDA liaison.
ICH - Guidelines of ICH-Q,S E,M.
Regulatory requirements of EU, MHRA, TGA and ROW countries.
12
hrs

4. Non clinical drug development: Global submission of

IND,NDA,ANDA.Investigation medicinal products dossier, dossier (IMPD) and
investigator brochure (IB)

12 hrs
5. Clinical trials: Developing clinical trial protocols. Institutional review board/
independent ethics committee Formulation and working procedures informed
Consent process and procedures. HIPAA- new, requirement to clinical study
process, pharmacovigilance safety monitoring in clinical trials.
12 hrs

REFERENCES

1. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and
IsaderKaufer,Marcel Dekker series, Vol.143
2. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert
P.Martin, Drugs and the Pharmaceutical Sciences,Vol.185, Informa Health care Publishers.
3. New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino,
MD,5th edition, Drugs and the Pharmaceutical Sciences,Vol.190.
4. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons.Inc.
5. FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics/edited
By Douglas J. Pisano, David Mantus.
6. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay
A.Rozovsky and Rodney K. Adams
7. www.ich.org/
8. www.fda.gov/
9. europa.eu/index_en.htm
10. https://www.tga.gov.au/tga-basics

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PRACTICALS (MPH104P)

1. Analysis of pharmacopoeial compounds and their formulations by UV Vis

spectrophotometer
2.Simultaneous estimation of multi component containing formulations by UV
spectrophotometry
3.Experiments based on HPLC
4.Experiments based on Gas Chromatography
5.Estimation of riboflavin/quinine sulphate by fluorimetry
6.Estimation of sodium/potassium by flame photometry
7. To perform In-vitro dissolution profile of CR/ SR marketed formulation

8.Formulation and evaluation of sustained release matrix tablets

9.Formulation and evaluation osmotically controlled DDS

10.Preparation and evaluation of Floating DDS- hydro dynamically balanced DDS

11.Formulation and evaluation of Muco adhesive tablets.
12.Formulation and evaluation of trans dermal patches.
13.To carry out preformulation studies of tablets.

14.To study the effect of compressional force on tablets disintegration time.

15.To study Micromeritic properties of powders and granulation.

16.To study the effect of particle size on dissolution of a tablet.

17.To study the effect of binders on dissolution of a tablet.
18.To plot Heckal plot, Higuchi and peppas plot and determine similarity factors.

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