RAJIV
GANDHI PROUDHYOGIKI VISHWAVIDYALAYA
M.
Pharm MODERN ANALYTICAL TECHNIQUES (MPY 101)
First Year 1st
Semester
Theory
1. Theory, Instrumentation, Methods
and Applications of VU
Spectrophotometer.
2. Theory and Instrumentation of IR
and FT-IR, its advantage and
applications in Structural
elucidation.
3. NMR, C13 NMR, Origin of
spectra, Chemical shifts, Spin-spin coupling,
Coupling constant, Instrumentation and
application for Structural
elucidation.
4. Mass spectra, Instrumentation,
Fragmentation pattern and applications
for Structural elucidation.
Application of GC-Mass, HPLC-Mass for
complex mixtures.
5. Theory, Instrumentation and
application for the following:
i) Fluorescence
ii) X – Ray crystallography
iii) Atomic spectroscopy
iv) Ultra centrifugation
v) ESR
vi) Liquid Scintillation spectrometry
vii) Auto radio grapy
6. Separation Techniques; Fundamental
principles, Basic
instrumentation, Qualitative and
Quantitative Pharmaceutical
applications of Gas-liquid
Chromatography, HPLC, HPTLC, Gel
Chromatography, Electrophoresis and
Ion-pair Chromatography.
7. General Principle, instrumentation
and application of optical rotatory
dispersion (ORD) and Circular
dichroism (CD).
8. Immunoassay Techniques: Enzyme and
Radioimmunoassay
techniques. Theory, Methods and
applications.
9. Thermal methods: Thermo Gravimetry
(TG), Differential Scanning
Calorimetry (DSC), Differential
Thermal Analysis (DTA).
10. Principles and application of
light, Phase contrast, Scanning and
Transmission electron microscopy,
Cytometry and Flow cytometry.
Books and References
Recommended:
1. Florey, Analytical Profiles of
Drugs, Vol.1-16.
2. Sinder, Text Book
of HPLC.
3. McLafferty, Mass
Spectrometry.
4. Rao,C.N., Ultraviolet Visible
Spectroscopy for Chemical Application.
5. Silverstein,
Basseler, Morril, Spectophotometrc Identification of Organic
Compounds.
6. Rao,C.N., Chemical Application
of Infrared Spectroscopy.
7. Weissberger, Physical
Methods in Organic Chemistry.
8. Kiencz, B. and
Dierasi, C., Interpretation of Mass Spectra of Organic
Compounds.
9. Jackmann, Application of NMR
Spectra to Organic Compounds.
10.Willard, Merrit and
Dean, Instrumental Methods of Analysis.
11. Elliel, E.L., Stereochemistry
of Carbon Compounds.
12. Naahod, P., Physical Methods of
Structure Determination.
13. Stahl, Thin Layer
Chromatography.
14. Ewing, Instrumental Methods of
Chemical Analysis.
15. Block and Durrum, Paper
Chromatography and Electrophoresis.
16. Remington’s Pharmaceutical
Sciences.
17. Sirmer, Spectroscopic
Analysis.
BIOTECHNOLOGY
& BIOINFORMATICS (MPY 102)
1. Genetics: Structure &
Function of DNA, DNA Replication & Repair,
Expression of Genetic Information:
Structure & Function of RNA,
Transcription, Genetic code,
Translation, Post translational modification.
2. Recombinant DNA Technology: Constructing
Recombinant DNA
molecules Restriction enzymes,
Vectors, Gene Cloning, Genomic libraries,
Polymerase Chain reaction – based DNA
cloning, Restriction mapping,
Blotting techniques, DNA sequencing,
Pharmaceutical applications of
recombinant DNA.
3. Gene Therapy: General Introduction,
Potential target diseases for Gene
therapy, Gene transfer methods,
Clinical studies, Pharmaceutical
production & Regulation.
4. Basics of
Immunology, Monoclonal antibodies & Hybridoma
technology & its
Applications.
Vaccines – Conventional
vaccines, Modern Vaccine technologies,
Genetically improved live vaccines,
Genetically improved subunit
vaccines, Pharmaceutical considerations.
5. Fundamentals of
Cell biology:
Cell organization and
plasma membrane: Transport
of
substances across the membrane.
Cellular
reproduction: The
Cell cycle, Mitosis & Meiosis,
Apoptosis.
Cell Signaling: Communication between
cells and their
environment
6. Molecular biology
of cancer: Causes
of Cancer & Genetics of Cancer,
New strategies for combating cancer.
7. Molecular, Structural and
Chemical Biology in pharmaceutical
research: Molecular biology of
disease and invivo transgenic models,
Genomic protein targets and
recombinant therapeutics, Structural biology
and rational drug design, Chemical
biology and Molecular diversity, Gene
therapy & DNA/ RNA targeted
therapeutics. Future of pharmaceutical
research.
8. Introduction to Bioinformatics: Biological
databases, Sequence
analysis, Protein structure, Genetic
and physical mapping, Application of
bioinformatics in pharmaceutical
industries.
9. Biostatistics – Graphical
representation of Data, Descriptive statistics,
Normal distribution, Probability
distribution, Sampling & Sampling plans.
Recommended Readings
1. Lehninger ., Principles of
Biochemistry
2. Karp, G.,Cell & Molecular
Biology.
3. Crommelin, D.J., A., and Sindelar
R.D., Pharmaceutical
Biotechnology.
4. Templeton N.S., and Lasic. D.D., Gene
Therapy.
5. Benjamin Lewin, Genes.
6. Watson and Trooze, Recombinant
DNA Techniques
7. Lesk., Introduction to
Bioinformatiics.
8. Watson, Molecular
Biology of cell.
9. Old and Primrose, Principles
of Gene Manipulations.
10. Watson, J.D., Gilman, M., Recombinant
DNA Technology
11. Baxevanis, A.D.,
Frana, Duelette, B.F.,Bioinformatics
12. Alberts, B., Johnson,
A., Lewin, J., Raff, M., Roberts, K., Walter, P.,
molecular biology of
the cell
13. Paul, W.E, Fundamentals
of Immunology
14. Klug, W.S., Cummings,
M.R., Essentials of Genetics
15. Glick, B.R.,
Pasternak, J.J., Molecular Biotechnology
16. Walker, J.M., Ripley,
R., Molecular biology and Biotechnology
17. Bolton, S.,
Pharmaceutical Statistics.
DRA, INTELLECTUAL
PROPERTY RIGHTS AND QUALITY
ASSURANCE
(MPY -103)
Theory
1. Requirements of GMP, CGMP, GLP,
USFDA, WHO guidelines and
ISO 9000 Series.
2. Drugs and Cosmetics Acts and Rules,
Drug Regulatory Affairs.
3. Documentation – Protocols, Forms
and Maintenance of records in
Pharmaceutical industry.
4. Clinical Trials and toxicological
evaluation of drugs. Preparation of
documents for New Drug Approval and
Export Registration.
5. Processing and its application,
Intellectual Property Rights (Patent,
Copy right and Trade marks).
6. Sewage disposal and Pollution
control.
7. Concepts in Validation, Validation
of manufacturing, Analytical and
Process validation and its
Application.
8. Basic concept of Quality Control
and Quality Assurance systems,
Source and Control of Quality
variation of Raw materials, Containers,
Closures, Personnel, Environmental,
etc.
9. In process quality control tests,
IPQC problems in Pharmaceutical
industries. ICH Guidelines
10. Sampling plans, Sampling and
Characteristic curves.
11. Master formula generation and
Maintenance, Standard Operating
Procedure (SOP) for different dosage
forms.
Books and References
Recommended:
1. Willing, Tuckerman
and Hitching, Good Manufacturing Practices for
Pharmaceuticals.
2. Drugs and Cosmetic
Acts and Rules.
3. Bharathi, Drugs and Pharmacy
Laws in India.
4. Patel, Industrial
Microbiology.
5. Loftus, B.T. and Nash,R.A., Pharmaceutical
Process Validation.
6. Bolton, S., Pharmaceutical
Statistics.
7. Banker, G.S. and Rhodes, C.T., Modern
Pharmaceutics.
8. OPPI, Quality
Assurance.
9. Carletiori, Validation of
Aseptic Pharmaceutical Process.
10. Garfield, Quality Assurance
Principles for Analytical Laboratories.
11. Indian
Pharmacopoeia.
12. British
Pharmacopoeia.
13. United State
Pharmacopoeia.
PRODUCT
DEVELOPMENT AND FORMULATION (MPY-104)
Theory
1. Preformulation
studies: Study
of physical, chemical and
pharmaceutical factors influencing
formulation of drugs.
2. Formulation
additives: Study
of formulation additives, Drug –
Excipient, Excipient - Excipient
interactions and Incompatibilities.
3. Solubilization: Theory of
solubilization, methods of solubility
enhancement and factor influencing
solubility. Solids dispersion.
4. Dissolution
Technology: Design
of dissolution apparatus, dissolution
media, dissolution testing of
different types of dosage formulations,
data interpretation, in-vitro and
in-vivo correlation.
5. Tablets: Recent advances in
tablet technology and automation in
manufacturing process, formulation and
evaluation of dispersible,
effervescent, floating and multilayers
tablets.
6. Formulation
consideration and evaluation: Parenterals and
Ophthalmics.
7. Polymers: Classification,
General method of synthesis, Properties,
Characterization, Evaluation and
Application in pharmacy. A detail
account of biodegradable polymers.
8. Nutraceuticals: Introduction,
formulations, uses, recent developments
and law governing nutraceuticals.
9. Pharmaceutical
packaging: Packaging
materials, type and tests of
containers and closures, Pilot plant
scale up technique.
10. Drug stability: Stability study
programmes for formulations.
Determination of Expiry date (shelf
life) and Overage calculations.
Stability indicating assays and ICH
guidelines for stability.
11.
OptimizationTechniques: Computers in pharmacy, Optimization
techniques, Computer aided drug
formulations.
Books and References
Recommended:
1. Swarbrick, J. and Boyran, J. C., Encyclopedia
of Pharmaceutical
Technology” Vol.1-3, Marcel
Dekkar, Inc., New York.
2. Gennaro, A.R., Remington’s “The
Science and practice of
Pharmacy”, Lippincot, Wiliams
& Wilkins, Philadelphia.
3. Aulton, M.E., “Pharmaceutics-
The science of doses form design”,
Churchill Livingstone, London.
4. Carstersen, J.T., “Drug
stability: Principal & practice”, Marcel
Dekker, Inc., NY
5. Banker and Rhodes, Modern
Pharmaceutics. Marcel Dekker Inc. NY.
6. Liium, L. and Davis, S.S.,
“Polymers in controlled drug delivery”,
Wright Bristol.
7. Kibbe, “ Hand book of
Pharmaceutical Excipients., Pharmaceutical
Press, London.
8. Lachmen, L. &
Lieberman, H.A., “ Theory and Practice of Industrial
Pharmacy”, Verghese publishing
house, Bombay.
9. Martin, Physical
Pharmacy.
10. Lieberman, H.A. &
Lachmen, L., “ Pharmaceutical Dosage forms –
Dispersed Systems’’ Vol.1-3 ,Marcel
Dekker, Inc., NY.
11. Avise, K. E. &
Lachmen, L., “ Pharmaceutical Dosage forms –
“Parenteral
Medications’’ Vol.1-3
,Marcel Dekker, Inc., NY.
12. Lieberman, H.A. &
Lachmen, L., “ Pharmaceutical Dosage forms –
Tablets’’ Vol.1-3 ,Marcel
Dekker, Inc., NY.
13. Yalkowsky,S.H.” Techniques
of Solubilization of drugs”, Marcel
Dekker, Inc., NY.
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