NIPER -GUWAHATI

SYLLABUS
M.S. (Pharm.) Pharmaceutics

NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH

GUWAHATI
SilaKatamur (Halugurisuk), P.O.: Changsari
Dist: Kamrup, Assam, Pin: 781101, Assam, India
Website: www.niperguwahati.ac.in
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M.S. (Pharm.) Pharmaceutics

Course No. Course Name Credits

Semester-I
PE-510 Pharmaceutical Preformulation-I 1
PE-520 Biopharmaceutics and Pharmacokinetics (Open 2
Elective for other than PE/PTF/PC)
PE-530 Pharmaceutical Preformulation-II 1
PE-540/PT-580 Regulatory Consideration for Pharm Development 1
MC-511 Spectral Analysis 2
GE-510 Biostatistics 2
GE-520 Fundamentals of Intellectual Property (IP) and 1
Technology Management
GE-511 Seminar 1
LG-510 General Laboratory Experience 3
Elective 2
TOTAL CREDITS 16
Semester-II
PE-620 Drug Delivery I (Controlled Drug Delivery) 2
PE-630 Pharmaceutical Product Development-I 1
PE-640 Pharmaceutical Product Development-II 2
PE-650 Drug Delivery II (Targeted drug delivery and Novel 2
Carrier Systems)
PE-660 Solid State Pharmaceutics 1
PA-630 Stability Testing 1
GE-611 Seminar 1
LS-610 General Lab Experience in the Area of Specialization 2
Elective 2
TOTAL CREDITS 14
Semester-III
Project (22 weeks)
TH-598 Synopsis 5
TH-599 Presentation 3
TOTAL CREDITS 8
Semester-IV
TH-698 Thesis 9
TH-699 Defence of Thesis 3
TOTAL CREDITS 12
GRAND TOTAL CREDITS (I to IV Semesters) 50
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M.S. (Pharm.) Pharmaceutics

Semester - I
PE-510 :- Pharmaceutical Preformulation - I (1 Credit)
1. Preformulation studies: Preformulation studies of drug substances, proteins and
peptides. Fundamental and derived properties in preformulation profiling,
Preformulation work-sheet.
2. Role of pre-formulation in drug discovery: material properties in lead selection,
drugability' of new chemical entities, in silico and high throughput pre-formulation
studies.
3. Role of preformulation in drug development: Preformulation as a support for
formulation development, identification of ‘developmental challenges’ during
pharmaceutical development, dosage form specific studies.
4. Salt selection: Role of salt selection in drug discovery and development, theoretical
concepts for selection of counter ions for salt formation, 'pKa rule' for salt formation,
decision tree for salt selection, appropriate case studies.
5. Solubilization: Solubility and solubilization of non-electrolyte, drug solubilization
in surfactant systems, use of co-solvents for development of liquid formulations,
solid-state manipulations including use of metastable solid forms like amorphous
state.
Recommended Books/Literature:
1. Mark Gibson Pharmaceutical Preformulation and Formulation- A Practical Guide from
Candidate Drug Selection to Commercial Dosage Form.
2. Simon Gaisford, Mark Saunders(auth.) Essentials of Pharmaceutical Preformulation.
3. Moji C Adeyeye H G Brittain Preformulation solid dosage form development.
4. Jens T. Carstensen Pharmaceutical Preformulation.

PE-520:- Biopharmaceutics and Pharmacokinetics (2 Credits)

1. Introduction: Definitions, ADME, concentration time profile, plotting the data,
different fluid compartments and blood flow rate compartment models, biological
half-life, elimination rate constant. Biopharmaceutics and pharmacokinetics in drug
research.
2. GIT Absorption of drugs: Mechanism, physico-chemical, biological and
pharmaceutical factors affecting drug absorption through GIT. Techniques for the
GIT absorption assessment .
3. Drug disposition: Total body clearance, renal clearance, mechanism of clearance,
clearance ratio, factors affecting renal clearance, hepatic clearance, volume of
distribution and its significance.
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4. Protein and tissue binding: Factors affecting protein binding, kinetics of protein
binding, determination of rate constant and different plots (direct, scatchard and
reciprocal), Implication of protein binding on pharmacokinetic parameters.
5. Bioavailability and Bioequivalence: Definitions, federal requirements, methods of
determination of bioavailability using blood and urinary excretion data. Protocol
design for bioavailability assessment. Methods for bioequivalence determination.
Protocol design for bioavailability and bioequivalence assessment. Methods
for bioequivalence determination. Regulatory perspective of design acceptance and
BE determination - BCS based approach to avoid human PK study for BE
determination.
6. Pharmacokinetic characterization of drugs: Pharmacokinetics of drugs following
one/two compartment open models with first order elimination kinetics as applied to
rapid intravenous injection, Intravenous transfusion and oral administration.
Determination of absorption rate constant using Wagner-Nelson, Loo Riegelman
methods. Flip-flop models, method of residual. Urinary excretion data and its
application in pharmacokinetic characterization of drugs. Pharmacokinetics of
multiple dosing. Pharmacokinetics of modified/sustained release dosage forms.
7. Dosage regimen: Dosage regimen adjustment in patients with renal and hepatic
diseases. Drug dosage in elderly, children, and obese patients.
8. Non-Linear Pharmacokinetics: Various causes of non-linearity, Michaelis-Menten
kinetics, In-vivo estimation of Km and Vm. Lineweaver Burk equation.
9. Physiologic pharmacokinetics models: Mean Residence Time (MRT); Statistical
moment theory; Mean absorption time (MAT); Mean dissolution time (MDT);
Lagrange and spline method Application and limitations of physiologic
pharmacokinetic models.
10. Miscellaneous Topics: Chronopharmacokinetics, Drug toxicity and forensic
pharmacokinetics, kinetics of maternal-fetal drug transfer, pharmacokinetics v/s
pharmacological/ clinical response, metabolic kinetics
Recommended Books

1. Applied biopharmaceutics pharmacokinetics. LEON SHARGEL AND ANDREW B.C. YU, 2016, 7 th
Edition.
2. Foundation of Pharmacokinetics. Rescigno, A. 2003.
3. Handbook of Bioequivalence Testing. Sarfaraz K. Niazi. 2007, 1st Edition.
4. Biopharmaceutics and Relevant Pharmacokinetics. Wagner, J. G. 1970.
5. Textbook of Biopharmaceutics and Clinical Pharmacokinetics. Niazi, S.K. 1980.
6. Modeling in Biopharmaceutics, Pharmacokinetics, and Pharmacodynamics: Homogeneous and
Heterogeneous Approaches. Macheras, P. and A. Iliadis, 2016, 2nd Edition.
7. Comparative Pharmacokinetics: Principles, Techniques and Applications. Riviere, J.E., 2011,
2nd Edition.
8. Introduction to Biopharmaceutics. Gibaldi, M. 1971.
9. Biopharmaceutics and Pharmacokinetics: An Introduction. Notari, R. E.2008.
10. BA/BE guidance of US FDA and EMEA, BCS waiver guidance by USFDA
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PE-530:- Pharmaceutical Preformulation – II (1 Credit)

1. Complexation: Metal and organic molecular complexes, inclusion compounds with

reference to cyclodextrins, chemical characteristics of inclusion complexes, methods
of preparation of cyclodextrin complexes, applications in solubilization / taste
masking / enhancement of permeability / enhancement of oral bioavailability.
2. Rheology: Methods for evaluation of viscosity, concept of Viscoelastic, Newtonian/
non-Newtonian flow properties, thixotropy and their applications in development of
dosage form, implications of viscosity on performance of liquid dosage forms like
suspensions and emulsions, advanced techniques / equipment employed in the
rheological characterization of pharmaceutical products.
3. Micromeritics: Particle size distribution, evaluation methods including advanced
techniques like atomic force microscopy, significance of particle size in different
dosage forms including aerosols, parenterals and solid dosage forms. Specific
Surface Area - its evaluation and importance in drug product development.
4. Dissolution: Theories of dissolution, release rates and constants, selection of
dissolution media, bio-relevant media, Mechanisms of conventional release and
controlled release, Dissolution data handling and correction factors, Dissolution
equipment and IVIVC. IVIVC correlation levels, procedure for IVIVC correlation.
Multimedia dissolution profile and applicability for biowaiver to be added. ICH Q8
reference to be included for pharmaceutical development for regulatory requirement.
Setting of dissolution specification - the regulatory expectation.
Recommended Books/Literature
1. Physical Pharmacy by Alfred Martin, 06th Edition
2. Martin’s Physical Pharmacy and Pharmaceutical Sciences, Fifth Edition, edited by Patrick J. Sinko,
BI Publications Pvt. Ltd.
3. M.E. Aulton, Pharmaceutics, The Science & Dosage Form Design, Churchill Livingstone, Edinburgh.
4. Remington’s Pharmaceutical Sciences, Mack Publishing Company, Pennsylvnia.
5. EMEA reflection paper for setting the dissolution specification.

PE 540:- Regulatory considerations for Pharmaceutical Development

(1 Credit)
1. International regulatory trends in pharmaceutical industry, Regulated and emerging
markets.
2. Role of regulatory affairs department in pharmaceutical organization:
regulatory audits, interactions with various other departments, single point contact
with regulatory agencies.
3. Types of regulatory filings for pharmaceutical products: Goals of regulatory
registration procedures investigational new drug applications, introduction to various
type of regulatory filings. DMF submission and CTD/eCTD.
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4. New drug applications : stages involved in NDA, different phrases of clinical trials,
purpose of IND, types and categories of IND applications information to be given in
IND applications.
5. Chemistry, manufacturing and control (CMC) information in NDA: information
related to drug substance like manufacturing process, specifications, description of
tests methods. Information related to drug product: description of method of
manufacturing, specifications and acceptable limits. Information related to placebo.
6. Hybrid NDA: a difference from NDA, historical background, literature based hybrid
NDAs and other sources of information for hybrid NDA, examples of types of
products considered under hybrid NDA.
7. Abbreviated New Drug applications (ANDAs): historical developments leading to
creation of ANDA process, Hatch Waxman Act, patent term restoration, criteria for
patent term extension, various types of Hatch Waxman Exclusivities, concept of
therapeutic equivalence, ANDA review process.
8. Paragraph IV certification ANDAs : different ANDA Patent certification options,
Medicare Modernization Act, implications of this act on 30 month stay period and
180 day exclusivity, triggering and forfeiture of 180 day exclusivity, shared
exclusivity.
9. ANDA with suitability petition: case studies of drug products considered
appropriate for filing under suitability petition.
10. Case studies related to above mentioned topics
Recommended Books/ Literature:
1. Javed Ali, Sanjula Baboota. Regulatory Affairs in the Pharmaceutical Industry, 2021, 1st Edition,
Elsevier, ISBN: 9780128222119.
2. Sandy Weinberg. Guidebook for Drug Regulatory Submissions, Wiley, ISBN: 978-0-470-37138-1.
3. David Mantus, Douglas J. Pisano. FDA Regulatory Affairs: Third Edition, CRC Press; 3rd edition,
ISBN: 978-1841849195.

MC-511:- Spectral Analysis (2 Credits)

1. Ultra Violet (UV) and visible spectroscopy:
a) Energy levels and selection rules: Definitions, molecular orbital approach for
energy absorption, various modes of transitions.
b) Correlation of structural variation with UV absorption: Factors influencing the
position and intensity of absorptions, Inductive and resonance effects, effect of ring
size, influence of stereochemical factors.
c) Predicting UV absorption: Woodward-Fieser, Fieser-Kuhn and Nelson rules;
d) Other factors: Non-conjugative effect, solvent effect, S-Cis band.
2. Infrared (IR)spectroscopy:
a) Characteristic regions of the spectrum: Various modes of vibrations, Energy
levels.
b) Correlation of structure with IR spectra: Influence of substituents, ring size,
hydrogen bonding, vibrational coupling and field effect on frequency.
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c) Applications: Determination of stereochemistry. Spectral interpretation with

examples
3. Nuclear Magnetic Resonance (NMR)spectroscopy:
a) Fundamentals: Physical basis, magnetic nuclei, resonance, relaxation processes,
signal-sensitivity.
b) Instrumentation: Continuous-Wave (CW) instrument, Pulsed Fourier Transform
(FT) instrument, Functions, Relation with sensitivity, Sampling.
c) 1H NMR, correlation of structure with spectra: Chemical environment and
shielding, chemical shift and origin of its concept, reference compound, local
diamagnetic shielding and magnetic anisotropy, relation with chemical shift,
chemical and magnetic non-equivalence, spin-spin splitting and its origin, Pascal's
triangle, coupling constant, mechanism of coupling, integral, NMR solvents and their
residual peaks, protons on heteroatoms, quadrupole broadening and decoupling,
effect of conformations and stereochemistry on the spectrum, Karplus relationship,
diastereomeric protons, Heteronuclear coupling to F and P, virtual coupling, long
range coupling-epi, peri, bay effects. Shift reagents-mechanism of action, spin
decoupling and double resonance. Explanation of spectra of some compounds and
drugs.
d) 13C NMR correlation of structure with spectra: Chemical environment, shielding
and carbon-13 chemical shift, calculation, proton-coupled C Spetra, Proton-
decoupled C spectra, Nuclear Overhauser Enhancement (NOE), Problem with
integration, Distortionless Enhancement by Polarization Transfer (DEFT),
Heteronuclear coupling for carbon to deuterium, carbon to F, carbon to P.
Explanation of spectra of some compounds and drugs.
4. Mass spectrometry (MS): Molecular ion and metastable peak, fragmentation
patterns, nitrogen and ring rules, McLafferty rearrangement, electron and chemical
ionization modes, applications.
Recommended Books:

1. Spectroscopy by Donald L Pavia, Gary M Lampman, George S Kriz, James A Vyvyan.

2. Organic spectroscopy by William Kemp.
3. Spectroscopic Methods in Organic Chemistry by Dudley H. Williams & Ian Fleming.
4. Spectrometric Identification of Organic Compounds by Robert M. Silverstein, Francis X. Webster &
David J. Kiemie
5. Applications of Absorption Spectroscopy of Organic Compounds by Dyer.
6. Fundamentals of Molecular Spectroscopy by Colin N. Banwell & Elaine M. McCash
7. Spectroscopy by Pavia, Donald L. Lampman, Gary M. Kriz, George S.

GE-510 :- Biostatistics (2 Credits)

1. Statistics: Introduction, its role and uses. Collection; Organization; Graphics and
pictorial representation of data; Measures of central tendencies and dispersion.
Coefficient of variation.
2. Probability: Basic concepts; Common probability distributions and probability
distributions related to normal distribution.
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3. Sampling: Simple random and other sampling procedures. Distribution of sample

mean and proportion.
4. Estimation and Hypothesis testing: Point and interval estimation including fiducial
limits. Concepts of hypothesis testing and types of errors. Student-t and Chi square
tests. Sample size and power.
5. Experimental design and analysis of variance: Completely randomized,
randomized blocks. Latin square and factorial designs. Post- hoc procedures.
6. Correlation and regression: Graphical presentation of two continuous variables;
Pearson's product moment correlation coefficient, its statistical significance.
Multiple and partial correlations. Linear regression; Regression line, coefficient of
determination, interval estimation and hypothesis testing for population slope.
Introduction to multiple linear regression model. Probit and logit transformations.
7. Non-parametric tests: Sign; Mann-Whitney U; Wilcoxon matched pair; Kruskal
wallis and Friedman two way anova tests. Spearman rank correlation.
8. Statistical techniques in pharmaceutics: Experimental design in clinical trials;
Parallel and crossover designs. Statistical test for bioequivalence. Dose response
studies; Statistical quality control.
Recommended Books:
1. Fundamentals of Biostatistics by Bernard Rosner.
2. Pharmaceutical Statistics: Practical and Clinical Applications by Bolton and Bon.
3. Statistical Misconceptions by Huck GE-520 Fundamentals of Intellectual Property (IP) and
Technology

GE-520 :- Fundamentals of Intellectual Property (IP) and Technology

Management (1 Credit)
1. Intellectual property: Concepts and fundamentals; Concepts regarding intellectual
property (IP), intellectual property protection (IPP) and intellectual property rights
(IPR); Economic importance, mechanisms for protection of intellectual property-
patents, copyrights, trademark; Factors effecting choice of IP protection; Penalities
for violation; Role of IPin pharmaceutical industry; Global ramifications and
financial implications.
2. Trade related aspects of intellectual property rights: Intellectual property and
international trade; Concept behind WTO (World Trade Organisation), WIPO
(World Intellectual Property Organisation) GATT (General Agreement on Tariff and
Trade), TRIPs (Trade Related Intellectual Property Rights),TRIMS(Trade Related
Investment Measures) and GATS(General Agreement on Trade in Services);
Protection of plant and animal genetic resources; Biological materials; Gene
patenting; Biotechnology / drug related IPR issues; Status in India and other
developing countries; Case studies and examples; TRIPS issues on herbal drugs.
3. Nuts and bolts of patenting, copyright and trademark protection criteria for
patentability, types of patents; Indian Patent Act, 1970; WTO and modifications
under TRIPS: Filing of a patent application; Precautions before patenting-
disclosures / non-disclosures, publication-article / thesis; Prior art search-published
patents, internet search patent sites, specialized services-search requests, costs;
Patent application-forms and guidelines, fee structure, time frames, jurisdiction
aspects; Types of patent applications- provisional, non provisional, PCT and
convention patent applications; International patenting-requirement procedures and
costs; Financial assistance for patenting- introduction to schemes by NRDC and
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TIFAC; Publication of patents-gazette of India, status in Europe and US; Patent

annuity; Patent attomeys technical aspects, criteria for selection, addresses, fee, rights
and responsibilities of a patentee; Practical aspects regarding maintaining of a
PATENT FILE; Patent infrigment- meaning, scope, litigation, case studies and
examples; Patenting by research students, lecturers and scientists University /
organisational rules in India and abroad; Thesis research paper publication, credit
sharing by workers, financial incentives; Useful information sources for patents
related information-internet sites, brouchers, periodicals, CD roms; Significance of
copyright protection for researchers; Indian Copyright Law and digital technologies-
Beme convention, WIPO copyright treaty (WCT), WIPO performance and
Phonogram Treaty (WPPT); Protection for computer data bases, multi media works;
Trade marks legislation and registration system in India-an introduction, meaning of
trademark criteria for eligibility; filling application for trademark registration; Trade
secrets-scope modalities and protection; Case studies-drug related patents
infringements.
4. Technology Development/transfer/commercialisation related aspects:
Technology development-meaning; Drug related technology development;
Toxicological studies, bioequivalence (BU), clinical trials-phase-I, phase-II and
phase-III; Approved bodies and agencies; Scale-up, semi-commercialisation and
commercialisation-practical aspects and problems; Significance of transfer of
technology (TOT), bottlenecks; Managing technology transfer-guidelines for
research students, scientists and related personnal; TOT agencies in India-APCTD,
NRDC, TIFAC, BCIL, TBSE/SIDBI; TOT related documentation-confidentiality
agreements, licensing, MOUs, legal issues; Compulsary licensing excess to medicine
issues; DOHA declaration, POSTWTO product patentregime from 2005; Challenges
for Indian pharmaceutical industry in the context of globalisation of IP; Drug
registration and licensing issues-national and global; Drug master file submissions,
SOPS; Related registration and marketing issues; Case studies antiretroviral drugs
and others.
5. Funding sources for commercialization of technology: Preparation of a project
report, financial appraisal, business models; GOI schemes and incentives; NRDC,
TePP, HGT, TDB schemes. PATSER; Venture capitalists, banks. Incubator concept-
Case studies with respect to IIT,CCMB, IMTECH, NIPER. Documentation and
related aspects.
6. Ethics and values in IP: IP and ethics-positive and negative aspects of IPP; Societal
responsibility; Avoiding unethical practices; Echo-responsibility-economic, social
and environmental benifits of modern biotechnology; Voluntary adoption of
pollution control strategies. 49 60 Courses of Study 2015.
Recommended Books:

1. Law Relating to Intellectual Property by B.L.Wadhera.

2. IPR Handbook for Pharma Students and Researchers by P.Bansal.
3. The Patents Act, 1970 (Bare Act with Short Notes) (New Delhi: Universal Law Publishing Company
Pvt. Ltd. 2012).
4. Patent Agent Examination by Sheetal Chopra and Akash Taneja.
5. Making Innovation Happen- A simple and Effective Guide to Turning Ideas into Reality by Michael
Morgan.
6. Making Breakthrough Innovation Happen by Porus Munshi.
7. Innovation X- Why a Company's Toughest Problems are its Greatest Advantage by Adam
Richardson.
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8. Legal Drafting for the Layman by Nabhi Kumar Jain.

9. How to Write and Publish a Scientific Paper by Rober A Day.
10. Concise Law Dictionary-with Legal Maxims, Latin Terms and Words and Phrases by Justice
Y.V.Chandrachud.
11. Biomedical Research- From Ideation to Publication by G.Jagadeesh and others.

GE-511 :- Seminar (1 Credit)

1. Introduction, Information retrieval systems.
2. Writing term papers and reports.
3. Organization of scientific material, thesis, dissertation and references.
4. Reading research papers.
5. Skills in oral presentation.
Each student has to present a seminar before end of the semester.

LG-510 :- General Laboratory Experience (3 Credits)

1. Analytical Techniques (75 hours):

a) Spectral analysis workshop (45 hours).
b) Separation techniques (30 hours).
2. Computer and application in pharmaceutical sciences (100 hours): Introduction
to computers, basic unit and functions, H/W and S/W, operating systems, word
processing, spread sheet, graphic programs, dbase, windows, statistical S/W
programs and packages. Steps involved in S/W development, computer languages
with emphasis to FORTRAN language and programming, hands on experience in
pharmaceutical software systems. Use of computers in information retrieval systems.
3. Pharmacology (25 hours): Animal handling, route of administration of drugs, dose
response relationship, acute toxicity testing of drugs, analgesic activity of a
compound, estimation of protein and haematological parameters.
4. Biotechnology in pharmaceutical sciences (20 hours): Day -1: Preparation for
plasmid miniprep. Day-2: Plasmid miniprep and restriction digestion. Day-3: Gel
electrophoresis and molecular weight calculation. Day-4: Discussion of result and
viva.
5. Specialization (50 hours):
a) To prepare granules by dry granulation using Roller compactor.
b) To optimize wet granulation process and perform scale up using Rapid
Mixer Granulator (RMG)
c) Study the dissolution behaviour/ drug release pattern of various
conventional, sustained release, enteric coated and nanoparticulate dosage
form and establishment of dissolution kinetics. Study of various factors
affecting dissolution / drug release
d) Study of drug protein binding and effect of competitive agent on binding
kinetics
e) Plotting and interpretation of pharmacokinetics data and calculation of
various pharmacokinetic parameter
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M.S. (Pharm.) Pharmaceutics

Semester - II
PE-620:- Drug Delivery– I (Controlled Drug Delivery)
(2 Credits)
1. Influence of drug properties and routes of drug administration on design of
sustained and controlled release systems: Rationale for controlled drug delivery,
physico-chemical properties and biological factors influencing the design and
performance of sustained/controlled release products.
2. Polymeric materials in controlled drug delivery: Polymer classification, physical
and chemical characterization techniques of biomaterials, biocompatibility testing of
biomaterials and their pharmaceutical/biomedical applications in tissue engineering
3. Biopharmaceutic and pharmacokinetic aspects of peroral Controlled Drug
Delivery Systems: Strategies and design, factors affecting controlled release drug
delivery system, Computation of desired release rate and dose for CRDDS,
Pharmacokinetic design for DDS; in-vitro/in-vivo considerations, Intermittent zero
order and first order release.
4. Peroral controlled release delivery: Design and fabrication of oral systems,
dissolution controlled release, diffusion and dissolution controlled release, Ion-
exchange resins, pH-independent formulations, osmotically controlled release,
altered density formulations, Case studies.
5. Parenteral drug delivery: Major routes of parenteral administration; selection,
design and development, biopharmaceutics of sustained/controlled release parenteral
drugs products, polymer microspheres and their biocompatibility and dispersed
DDS.
6. Transdermal / skin drug delivery system: Principles of skin permeation, factors
affecting percutaneous absorption of drug, sorption promoters, absorption
enhancement by energy input- Iontophoresis, sonophoresis, electroporation, and heat
assisted TDDS. Pharmacokinetics of skin permeation, design, development and
evaluation of transdermal patches, overview of micro needles in transdermal drug
delivery.
7. Implantable Therapeutics Systems - Historical background; Advantages,
disadvantage and applications; Types of implantable therapeutic systems including
self-regulated and implantable pump systems; non-biodegradable and biodegradable
polymers used for implantable systems, Tissue and blood compatibility testing.
8. Proteins / peptides drug delivery systems: Enzyme, epithelial/endothelial barriers,
pharmacokinetics, different routes of delivery, practical considerations, Carrier
mediated transport of peptides and its analogues; problems associated with delivery
of proteins and peptides.
9. Controlled release formulations for alternate routes of administration:
Consideration for controlled release in pulmonary/nasal drug delivery, bioadhesive
systems and controlled ocular delivery (Ocusert systems).
10. Role of controlled release in veterinary formulations: Background and present
scenario, formulation considerations, major hurdles and challenges, future prospects.

Recommended Books/Literature:
1. Controlled and Novel Drug Delivery, Jain, N.K. 1997.
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2. Advances in Novel and Controlled Drug Delivery, Jain, N.K., CBS publisher.
3. Novel Drug Delivery Systems Chien, Y.W, Taylor & Francis, Second Edition.
4. Controlled and Novel Drug Delivery, Robinson, J.R. & Lee, V.H.I. Taylor & Francis, 2nd edition.
5. Targeted & Controlled Drug Delivery, Vyas S.P. & Khar R.K, CBS Publisher.
6. Applied Biopharmaceutics& Pharmacokinetics, by Shargel, L., S. Wu-Pong.
7. Biopharmaceutics and Pharmacokinetics: An Introduction by Notari, R. E.
8. Introduction to Biopharmaceutics, by Gibaldi, M.

PE-630 :- Pharmaceutical Product Development – I (2 Credits)

1. Development of dosage forms: Four stage development including preformulation,
prototype development, scale up studies and commercialization, Post commercial
monitoring of the product (Pharmacovigilance) as product lifecycle management
2. Design of materials and product specifications: Creation and optimization of
material and product specifications. In-process, product release and regulatory
specifications.
3. Quality by design (QbD): Fundamentals of pharmaceutical quality by design,
identification of critical quality attributes, critical material attributes, critical process
parameters and quality risk management. Identification of QTPP; and formulation by
design.
4. Methods of optimization – OVAT and Design of experiments (DOE). Experimental
designs, Screening design and modelling design, factorial design(s) and Taguchi
design, Central composite design, Box-Behnken Design and Plackett- Burman
design, mixture designs, response surface methodology. Applications of systematic
optimization techniques.
5. Process analytical technology (PAT) and other control strategies for QbD.
6. Pharmaceutical Packaging: Pack types for different dosage forms, packaging
materials like glass and plastic, selection of proper material, labelling, preformulation
screening of package components; barrier, child resistance and temper evident
packaging systems; regulatory perspectives.
7. Testing of packaging materials – equipment used, extractable and leachable.
8. Documentation protocols: Forms and maintenance of records in product
development department including clinical batches.
Recommended Books/Literature:
1. Javed Ali, Sanjula Baboota. Regulatory Affairs in the Pharmaceutical Industry, 2021, 1st Edition,
Elsevier, ISBN: 9780128222119.
2. Sandy Weinberg. Guidebook for Drug Regulatory Submissions, Wiley, ISBN: 978-0-470-
37138-1.
3. David Mantus, Douglas J. Pisano. FDA Regulatory Affairs: Third Edition, CRC Press; 3rd edition,
ISBN: 978-1841849195.

PE-640:- Pharmaceutical Product development-II (2 Credits)

1. Formulation additives: Study of different types of additives e.g. antioxidants and
preservatives, coloring and flavouring agents, emulsifying and suspending agents,
basic materials for ointment bases, diluents and pharmaceutical solvents, regulatory
perspectives: GRAS, IIG; new developments in excipient science, functional and co-
processed excipients, international patented excipients. Implications of quantitative
selection of each excipient in product development.
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2. Drug-excipient interaction: Drug-excipient interaction and incompatibilities like

physical, chemical, pharmaceutical and therapeutic, analytical techniques to
characterize drug-excipient incompatibility.
3. Improved tablet production: Advances in materials, material handling, granulation
equipments and granulation technologies; process automation. Processing problems
in tablet and troubleshooting.
4. Tablet coating: Advances equipment for coating, sugar coating, film coating,
advanced coating technologies, aqueous based film coating, solvent free coating,
coating defects.
5. Specialized tablets: Formulation and evaluation of effervescent, orodispersible and
chewable tablets, Regulatory expectation of Target Product Profile (TPP).
6. Liquid and poly-disperse systems: Suspensions: theoretical considerations,
flocculated and deflocculated suspensions, adjuvants utilized, evaluation of
suspension stability. Emulsions: descriptive theory of emulsification, formulation
aspects, stability evaluation, advances in emulsion technology-multiple, micro and
nano emulsions.
7. Sterile products and admixtures: Formulation development, vehicles and other
additives, containers and closures, evaluation of stability and sterility, requirements
of facilities for production, recent advances and developments.
8. Drug Nano-crystals: Generation – ‘top down approach, ‘bottoms up approach’ and
‘mixed approaches’, stabilization of nano-crystals and their applications.
9. Inhalation Products: Nebulizers, Inhalers – Metered Dose Inhalers (MDI) and Dry
Powder Inhalers (DPIs) : Formulation aspects, types of excipients / propellants,
devices used and stability aspects.
10. Herbal Formulation Development: Importance of herbal formulations, Challenges,
Formulation considerations, testing of herbal formulations, Regulatory guidelines,
Stability considerations and future prospects.
Recommended Books/Literature:
1. Pharmaceutical dosage forms- -tablets I edited by Herbert A. Lieberman, Leon Lachman, Joseph B.
Schwartz. -- 2nd ed., rev.
2. Pharmaceutical Coating Technology, edited by Graham Cole.
3. M.E. Aulton, Pharmaceutics, The Science& Dosage Form Design, Churchill Livingstone, Edinburgh.
4. Remington’s Pharmaceutical Sciences, By Mack Publishing Company, Pennsylvania.
5. Shape /Size guidance by US-FDA.
6. Score line guidance by US FDA.
7. Chewable Tablet guidance by US FDA.
8. USFDA guidance for orodispersible /orally disintegrating Tablets.
9. Indian Herbal Pharmacopoeia.

PE-650 :- Drug Delivery -II (Targeted Drug Delivery and Novel Carrier Systems)
(2 Credits)
1. Fundamentals of targeted drug delivery: Need of targeted drug delivery, ligand-
receptor interaction, levels of targeting, active and passive targeting, EPR effects,
receptor-mediated endocytosis, multifunctional approach in targeted drug delivery.
2. Chemical drug delivery systems: Prodrug concept for drug design, drug targeting
and antibody-directed enzyme prodrug therapy (ADEPT), soft drug design, Lipid-
drug/ polymer-drug conjugate.
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3. Targeted brain delivery: Overview of brain, specific targets for brain delivery,
concept of nose to brain delivery, types and key elements: Ideal carrier system and
approach with case studies depicting utility in various brain diseases.
4. Targeted Tumor Delivery: Structural features of tumor vasculature, levels of tumor
targeting, tumor ligands for targeted drug delivery, biopharmaceutical characteristics
of delivery systems for tumor-specific delivery.
5. Colloidal and Supramolecular drug delivery systems: Preparation and
characterization, biopharmaceutical considerations, evaluation, and applications in
drug delivery of the following delivery vectors: a) Liposomes and niosomes b) Solid
lipid nanoparticles and nanostructured lipid carriers c) Polymeric nanoparticles –
PLGA, chitosan, albumin, gelatin, alginate etc. d) Carbon nanotubes, (e)
microspheres (f) microemulsions (g) SEDDS and SNEDDS.
6. Overview of Specialized drug delivery systems: Transfersomes, Ethosomes,
Layersomes, Bilosomes, Emulsomes, Virosomes, Cubosomes, Aquasomes,
Pharmacosomes. Dendrimers, Polymeric micelles and Resealed Erythrocytes.
7. Stimuli-responsive drug delivery systems: Magnetically, thermal and pH-assisted
drug delivery systems.
8. Miscellaneous targeting approaches: Fundamentals of gene delivery, Overview of
colon, liver, macrophage, mitochondrial and M cells targeting.
Recommended Books/Literature:
1. Controlled and Novel Drug Delivery, Jain, N.K. 1997.
2. Advances in Novel and Controlled Drug Delivery, Jain, N.K., CBS publisher.
3. Novel Drug Delivery Systems Chien, Y.W, Taylor & Francis, Second Edition.
4. Controlled and Novel Drug Delivery, Robinson, J.R. & Lee, V.H.I. Taylor & Francis, 2nd edition.
5. Targeted & Controlled Drug Delivery, Vyas S.P. & Khar R.K, CBS Publisher.

PE-660:- Solid State Pharmaceutics (2 Credits)

1. Levels of solid state properties: Molecular / particle / bulk level properties,
interdependence of various levels on each other, role of different levels during
pharmaceutical development and process development.
2. Molecular level: Crystalline form, concept of long range order, supramolecular
arrangements, building blocks of crystals, unit cell, basic types of unit cells,
demonstration of unit cells using crystal visualization softwares.
3. Polymorphism: Definition, significance of polymorphism in drug product
performance, packing / conformational polymorphism, thermodynamics of
polymorphs, enatiotropy / monotropy, concept of transition temperature, Burger and
Ramberger rule.
4. Crystallization process: Molecular aggregation events in crystallization, energetic
of crystallization, enthalpy entropy balance, types of nucleation, Ostwald's step rule,
experimental protocols for polymorph screening.
5. Implications of polymorphism in pharmaceutical development: Regulatory
concerns related to polymorphism, introduction to latest regulatory position on
polymorphism.
6. Amorphous state: Definition, long range order versus short range order, disorder in
the amorphous state, concept of glass transition temperature (Tg), thermodynamic
necessity for Tg, entropy crisis.
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7. Role of amorphous state in drug delivery: Solubility advantage, spring parachute

effect during solubility studies, physical instability of the amorphous form,
techniques for stabilization of amorphous form, amorphous solid dispersions.
8. Co-crystals: Introduction, synthons used for formation of co-crystals and
applications in drug delivery, Regulatory expectation of co-crystals.
9. Particulate level properties: Crystal habit, generation of different crystal habits,
implications of crystal habit on product performance and processing.
10. Bulk level: Bulk density, compressibility, flow properties, cohesivity, electrostatics,
aggregation, agglomeration, role in formulation development and processing.
Recommended Books/Literature:
1. Polymorphism in Pharmaceutical Solids Edited by Harry Brittain.
2. Solid State Characterization of Pharmaceuticals Edited by Angeline and Mark Zarkrzewski
3. Crystal Engineering: A textbook, Edited by G. R. Desiraju, J. J.Vittal and A. Ramanan.
4. USFDA guidance for Co crystals.

PA-630:- Stability Testing (2 Credits)

11. Drug development cycles and stability testing: Role and types of stability studies
during different stages of drug and product development.
12. Drug stability testing guidelines: International, Regional, and National drug
stability guidelines.
13. WHO vs. ICH drug stability testing guidelines: Comparison of different aspects
in WHO guideline, and critical comparison with ICH parent guideline Q1A(R2).
14. Specific discussion on following ICH guidelines: Q1B, Q1C, Q1D, Q1E and Q5C.
15. Additional topics:
a) Stress testing and stability-indicating method development: Role, regulatory
aspects, protocols/approaches, practical considerations.
b) Stability testing of phytopharmaceuticals and Herbal products: Regulatory
requirements including EMA for herbal products.
c) Stability test equipment: Types of stability chambers (walk-in, stand-alone),
design considerations, qualification and other critical issues.
d) Stability testing for Shipping & Distribution: Stability testing during transport.
e) Stability testing of drug delivery systems.
Recommended Books/Literature:
10. ICH (www.ich.org) and WHO (www.who.int) guidelines
11. Pharmaceutical Stress Testing (Predicting Drug Degradation) by Steven Baertschi a. and Karen
Alsante
12. Drug Stability (Principles and Practices) by S. James, Jens ThurØCarstensen
13. Stability-indicating HPLC Methods for Drug Analysis by Quanyun A. Xu, Lawrence A. Trissel
14. Stability of Drugs and Dosage Forms by Sumic Yoshioka, Valentino Stella
15. Physical Pharmacy and Pharmaceutical Sciences by Patrick Sinko, Alfred Martin
16. New Drug Approval Process (Chapter 7) by Richard Guarino
17. Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and
Best Practices by Kim Huynh-Ba
18. Stability and Characterization of Protein & Peptide of Drugs by Y. John Wang
19. Peptide and Protein Drug Analysis by Ronald Reid
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GE-611:- Seminar (1 Credit)

Students are required to submit a written record and present details of the project to
be pursued in semester-III & IV. This should include the purpose and basis of the
project, stating aims, objectives and probable outcomes, be able to supplement these
with necessary information, literature review towards it and process for the project
itself.