NIPER HYDERABAD

I Semester
PE-510 Dosage Form Design Parameters (1 credit)
1) Physicochemical aspects
a) pKa b) Partition Coefficient c) Solubility d) Reaction kinetics and mechanisms.
2: Biological aspects
a) Role of physicochemical parameters on drug absorption and their Implications.
b) Routes of administrations and implication on bioavailability.
c) Physicochemical aspects of drugs and first pass metabolism.
3: Dissolution
a) Theories of dissolution, release rates and constants.
b) Mechanisms of conventional release and controlled release.
c) Dissolution data handling and correction factors.
d) Dissolution equipments.
e) IVIVC.
Recommended books:
1. Martin's Physical Pharmacy and Pharmaceutical Scinces by P.J. Sinko
2. Pharmaceutical Dosage Forms and Drug Delivery, by Mahato R.I. and Narang A.S

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 absorptionassessment.
3. Drug disposition: Total body clearance, renal clearance, mechanism of clearance,clearance
ratio, factors affecting renal clearance, hepatic clearance, volume of distributionand its
significance.
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.
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 ofabsorption rate
constant usingWagner-Nelson, Loo Riegelman methods. Flip-flop models,method of residual.
Urinary excretion data and its application in pharmacokineticcharacterization of drugs.
Pharmacokinetics of multiple dosing.

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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-Mentenkinetics, n-
vivo estimation ofKmand Vm. Case studies.
9. Physiologic pharmacokinetics models: Mean Residence Time; Statistical
MomentTheory;Application and limitations of physiologic pharmacokinetic models.
10. MiscellaneousTopics: Chronopharmacokinetics, Drugtoxicity and forensic pharmacokinetics,
kinetics of maternal-fetal drug transfer, pharmacokinetics v/spharmacological/ clinical response,
metabolic kinetics.

Recommended books:
1. Applied Biopharmaceutics & Pharmacokinetics, by Shargel, L., S. Wu-Pong
2. Biopharmaceutics and Pharmacokinetics: An Introduction by Notari, R. E.
3. Introduction to Biopharmaceutics, by Gibaldi, M.
4. Biopharmaceutics and Relevant Pharmacokinetics, by Wagner, J. G.
5. Textbook of Biopharmaceutics and Clinical Pharmacokinetics by Niazi, S.K.
6. Handbook of Bioequivalence Testing, by Niazi, S. K.
7. Modeling in Biopharmaceutics, Pharmacokinetics, and Pharmacodynamics: Homogeneous
and heterogeneous Approaches, by Macheras, P. and A. Iliadis
8. Comparative Pharmacokinetics: Principles, Techniques and Applications, by Riviere, J. E
9. Foundations of Pharmacokinetics, by Rescigno, A.
10. Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications, by
Rowland,M.and T. N. Tozer

MC-510 Basics of Drug Action (2 credits)

(Refer to Page No. 02)

MC-511 Spectral Analysis (2 credits)

(Refer to Page No. 03)

NP-510 Separation Techniques (1 credit)

(Refer to Page No. 14)

BT-510 Biotechnology in Pharmaceutical Sciences (1 credit)

(Refer to Page No. 28)

GE-510 Biostatistics (2 credits)

(Refer to Page No. 15)

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

Management (1 credit)
(Refer to Page No. 16)

GE-511 Seminar (1 credit)

(Refer to Page No. 17)

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, d base, 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 an 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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II Semester
PE-620 Drug Delivery Systems (2 credits)
1. Influence of Drug Properties and Routes of Drug Administration on the design of sustained and
controlled release systems: Rationale for controlled drug delivery,physiochemical properties
and biological factors influencing the design and performance of sustained/controlled release
products.
2. Biopharmaceutic and pharmacokinetic aspects of PO CRDDS: Strategies and design, factor
effecting controlled release drug delivery systems, 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.
3. Peroral controlled-release delivery: Design and fabrication of oral systems, dissolution controlled
release, diffusion controlled release, diffusion and dissolution controlled release, ion-exchange
resins, pH-independent formulations, osmotically controlled release, altered density
formulations, Case studies.
4. Parenteral drug delivery: Major routes of parenteral administration; selection, design and
development, biopharmaceutics of sustained/controlled release parenteral drug products,
polymer microspheres and their biocompatibility and dispersed DDS.
5. Transdermal/skin drug delivery system Principles of skin permeation, factors affecting
percutaneous absorption of drugs, sorption promoters, absorption enhancement by energy
input - iontophoresis, sonophoresis and electroporation, pharmacokinetics of skin permeation,
development and evaluation of transdermal devices, Case studies.
6. Implantable Therapeutic Systems:Introduction, Historical Development, Approaches to
development of Implantable therapeutic systems, Benefits of controlled drug administration
via implantation, Medical aspects of Implantation.
7. Drug targeting:. Different levels of targeting-first order, second order and third order targeting,
active and passive targeting,EPReffect, receptor mediated endocytosis, prodrug based drug
targeting, brain targeting, tumor targeting.
8. Overview of different carrier systems for drug delivery: Microparticles, liposomes, niosomes,
polymeric nanoparticles, solid lipid nanoparticles, carbon nanotubes etc.
9. Protein/peptide drug delivery systems: Enzyme, epithelial/endothelial barriers,
pharmacokinetics, different routes of delivery, practical considerations.
10. Regulatory Assessement of controlled release products: Potential pharmacodynamic and
bioavailability problems of oral controlled release products, dissolution rate assessment,
biopharmaceutic considerations in the regulatory assessment

Recommended books:
1. Drug Delivery Systems, by KKJain.
2. Pharmaceutical Perspectives of Cancer Therapeutics, byYLu and R.I. Mahato.
3. Targeted Delivery of Small and Macromolecular Drugs, byA.S. Narang and R.I. Mahato.
4. Controlled Drug Delivery, Fundamentals andApplications, by Robinson and Lee.

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5. Controlled Drug Delivery Concepts &Advances, by SPVyas andRKKhar.

6. Targeted and Controlled Drug Delivery: Novel Carrier Systems, by SPVyas andRKKhar.

PE-630 Pharmaceutical Product Development-I (2 credits)

1. Preformulation studies: Preformulation studies of drug substances, proteins and peptides.
Fundamental and derived properties in pre-formulation profiling, Preformulation work sheet.
2. Role of pre-formulation in drug discovery: Material properties in lead selection, high throughput
pre-formulation studies, 'drugability' of new chemical entities, tools to assist in lead selection.
3. Role of preformulation in drug development: Preformulation as a support for formulation
development, identification of challenges during formulation 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, case study.
5. Complexation: Metal and organic molecular complexes, inclusion compounds with reference
to cyclodextrins, chemical characteristics of inclusion complexes, applications in solubilization
/ taste masking / enhancement of permeability / enhancement of oral bioavailability, methods
of preparation of cyclodextrin complexes.
6. 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 forms like amorphous state and drugderivatization.
7. Rheology: Thixotropy, methods for evaluation of viscosity, implications of viscosity on
performance of liquid dosage forms like suspensions and emulsions.
8. 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.
9. Development of dosage forms: Four stage development including preformulation / prototype
development / scale up studies / commercialization, biological basis and opportunities, dosage
form and its implications; Manipulation of physiological processes.
10. Case studies will be discussed after each topic with current literature, case study dealingwith
use of preformulation data for lead selection and dosage form decisions.

Recommended books:
1. Performulation in Solid Dosage Form Development, Edited by Moji Christianah Adeyeye and
HarryG. Brittain
2. Handbook of Performulation, Edited by Sarfaraz K. Niazi
3. Handbook of Pharmaceutical Salts, Edited by P.Heinrich Stahl and Camille G.Wermuth.

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, basicmaterials for ointment
bases, diluents and pharmaceutical solvents, regulatory perspectives: GRAS, IIG; new

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developments in excipient science, functional and coprocessedexcipients, international

patented excipients. Implication of quantitative selection of each excipient in product
development.
2. Drug-excipient interaction: Drug-excipient interaction and incompatibilities, physical, chemical,
pharmaceutical and therapeutic, analytical techniques to characterize drug excipient
incompatibility.
3. Solid dosage forms: Tablets, benefits, improved tablet production, advances in materials, material
handling and granulation; process automation. Processing problems in tablet and
troubleshooting. Specialized tablets: Formulation and evaluation of effervescent, oro dispersible
and chewable tablets.
4. Tablet coating: Coating pans, sugar coating, film coating, advanced coating technologies,
aqueous based film coating, solvent free coating, coating defects.
5. 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.
6. 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.
7. Aerosols: Components of aerosol package, containers, nebulizers, pressured metered dose
inhalers, dry powder inhalers, formulation aspects, types of propellants used, stability testing
of pharmaceutical aerosols, Quality control and testing evaluation of pharmaceutical aerosols.
8. Package development: Package types for different dosage forms, packaging materials like
glass and plastic, selection of proper material, labelling, preformulation screening of package
components, regulatory perspectives.
9. Design of materials and product specifications: Factory design, laying down and optimization
of material and product specifications, process and in-process controls
10. Documentation protocols: Forms and maintenance of records in product development
department including clinical batches.

Recommended books:
1. Handbook of Pharmaceutical Excipients, by Rowe, R.C.,P. J. Sheskey
2. Pharmaceutical Excipients: Characterization by M. Dekker. Bugay,D.E. andW.P. Findlay
3. Pharmaceutical Manufacturing Handbook: Production and Processes, by Gad, S.C
4. Selected Pharmaceutical Excipients: Physicochemical Properties, Analytical Techniques
Utilized and their Excipient-Excipient Interactions by Rane, S. C.
5. Encyclopedia of PharmaceuticalTechnology, by Swarbrick, J. and J.C. Boylan
6. Packaging of Pharmaceuticals and Healthcare Products, by Lockhart, H. and F.A. Paine
7. Pharmaceutical PackagingTechnology, by Dean, D.A., R. Evans
8. Pharmaceutical Packaging Handbook, Informa Healthcare by Bauer,E. J.
9. Pharmaceutical Manufacturing Handbook: Regulations and Quality, Wiley-Interscience by Gad,
S. C.WHOPublications:

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10. Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials.

11. Good Manufacturing Practices and Inspection,World Health Organization.
12. Modern Pharmaceutics, Marcel Dekker by Banker, G.S. and C.T. Rhodes
13. Pharmaceutical Dosage Forms, by Lieberman, H.A. and L. Lachman
14. Pharmaceutical Dosage Forms: Parenteral Medications, byAvis, K. E., H.A. Lieberman

PE-650 Biomaterials (2 credits)

1. Introduction to biomaterials: Fundamentals of polymer science and polymer classification.
2. Synthesis and modification methods of biomaterials: Polymerization methods, polymer
fabrication.
3. Physical and chemical characterization techniques of biomaterials: Thermal, spectroscopic,
microscopic and laser based techniques.
4. Manipulating biomaterials in various forms depending upon end use specification: Hydrogels,
micro and nano particles, films, fibres.
5. Host reaction to biomaterials and their evaluation: Inflammation, wound healing,foreign body
response, systematic toxicity
6. Biocompatibility testing of biomaterials:assessment of tissue compatibility, assessment of
tissue compatiability, testing blood materials interactions.
7. Degradation of biomaterials in biological environment: Chemical and biochemical degradation
of polymers; Degradative effects of biological environment.
8. Use of polymers in controlled release of active agents:Diffusion controlled devices, Solvent-
controlled devices and chemically controlled devices.
9. Regulatory considerations:Assessment of safety and long term toxicity evaluation, toxicity
considerations on repetitive accumulation of polymeric materials.
10. Pharmaceutical and biomedical applications: Drug delivery, tissue engineering.

Recommended books:
1. Handbook of Biodegradable Polymers, byAbraham J. Domb, David M. Wiseman
2. Biodegradable Polymers in Clinical Use and Clinical Development, by Domb, Kumar andAzra
3. Surface modification of Biomaterials: MethodsAnalysis andApplications, Edited byRWilliams

PE-660 Solid State Pharmaceutics (1 credit)

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, definition, 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.

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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.
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. Particulate level properties: Crystal habit, generation of different crystal habits, implications of
crystal habit on product performance and processing.
9. Bulk level: Bulk density, compressibility, flow properties, cohesivity, electrostatics, aggregation,
agglomeration, role in formulation development and processing.

Books recommended:
1. Polymorphism in Pharmaceutical Solids Edited by Harry Brittain
2. Solid State Characterization of Pharmaceuticals Edited byAngeline and Mark Zarkrzewski
3. Crystal Engineering:Atextbook, Edited by G. R. Desiraju, J. J.Vittal andA. Ramanan

PC-610 Drug Metabolism (1 credit)

(Refer to Page No. 29)

PC-611 Pharmacological Screening and Assays (1 credit)

(Refer to Page No. 30)

GE-611 Seminar (1 credit)

(Refer to Page No. 23)

LS-610 General Laboratory Experience -10 hours/week (2 credits)

Preparation and evaluation of biomaterials for different DDS, development and evaluation of drugdelivery
systems, formulation development and evaluation.

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