INDUSTRIALPHARMACY(MIP)
MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES (MIP 101T)
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
UV-Visible spectroscopy: Introduction, Theory, Laws, Instrumentation 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.
NMR spectroscopy: Quantum numbers and their role in NMR, Principle, 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.
11
Hrs
11
Hrs
Mass Spectroscopy: Principle, Theory, Instrumentation of Mass 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
Chromatography: Principle, apparatus, instrumentation, chromatographic parameters, factors affecting resolution and applications of the following:
Paper chromatography b) Thin Layer chromatography
c) Ion exchange chromatography d) Column chromatography
e) Gas chromatography f) High Performance Liquid chromatography
g) Affinity chromatography
Electrophoresis: Principle, Instrumentation, Working conditions, factors affecting separation and applications of the following:
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: Radioimmunology assay (RIA), ELISA (Theory & practical) and knowledge on Bioluminescence assays.
11
Hrs
11
Hrs
11
Hrs
Hrs
REFERENCES
1. Spectrometric Identification of Organic compounds - Robert M Silverstein,
th
edition, John Wiley & Sons, 2004.
Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler, Timothy A. Nieman, 5th edition, Eastern press , Bangalore, 1998.
t h
Instrumental methods of analysis – Willards, 7 edition, CBS publishers.
th
Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4 edition, CBS Publishers, New Delhi, 1997.
Organic Spectroscopy - William Kemp, 3rd edition, ELBS, 1991.
Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi, 3rd Edition, CBS Publishers, New Delhi, 1997.
Pharmaceutical Analysis- Modern methods – Part B - J W Munson, Volume 11, Marcel Dekker Series
PHARMACEUTICAL FORMULATION DEVELOPMENT (MIP 102T)
Scope
This course is designed to impart knowledge and skills necessary to train the students on par with the routine of Industrial activities in R&D and F&D.
Objectives
On completion of this course it is expected that students will be able to understand-
The scheduled activities in a Pharmaceutical firm.
The pre formulation studies of pilot batches of pharmaceutical industry.
The significance of dissolution and product stability
THEORY 60 Hrs
1. Preformulation Studies: Molecular optimization of APIs (drug substances), crystal morphology and variations, powder flow, structure modification, drug-excipient compatibility studies, methods of determination.
Formulation Additives: Study of different formulation additives, factors influencing their incorporation, role of formulation development and processing, new developments in excipient science. Design of experiments – factorial design for product and process development.
Solubility: Importance, experimental determination, phase- solubility analysis, pH-solubility profile, solubility techniques to improve solubility and utilization of analytical methods – cosolvency, salt formation, complexation, solid dispersion, micellar solubilization and hydrotropy.
Dissolution: Theories, mechanisms of dissolution, in-vitro dissolution testing models – sink and non-sink. Factors influencing dissolution and intrinsic dissolution studies. Dissolution test apparatus – designs, dissolution testing for conventional and controlled release products. Data handling and correction factor. Biorelevent media, in-vitro and in-vivo correlations, levels of correlations.
12
Hrs
12
Hrs
12
Hrs
12
Hrs
Product Stability: Degradation kinetics, mechanisms, stability testing of drugs and pharmaceuticals, factors influencing-media effects and pH effects, accelerated stability studies, interpretation of kinetic data (API & tablets). Solid state stability and shelf life assignment. Stability protocols, reports and ICH guidelines.
12
Hrs
REFERENCES
Lachman L, Lieberman HA, Kanig JL. The Theory and Practice Of
rd
Industrial Pharmacy, 3 ed., Varghese Publishers, Mumbai 1991.
th
Sinko PJ. Martin's physical pharmacy and pharmaceutical sciences, 5 ed., B.I. Publications Pvt. Ltd, Noida, 2006.
Lieberman HA, Lachman L, Schwartz JB. Pharmaceutical dosage forms:
nd
tablets Vol. I-III, 2 ed., CBS Publishers & distributors, New Delhi, 2005.
Conners KA. A Text book of pharmaceutical analysi Wells JI. Pharmaceutical preformulation: The physicochemical properties of drug substances. Ellis Horwood Ltd., England, 1998.
Yalkowsky SH. Techniques of solubilization of drugs. Vol-12. Marcel Dekker Inc., New York, 1981
Dressman J, Kramer J. Pharmaceutical dissolution testing. Saurah printer pvt. Ltd., New Delhi,2005.
rd
Sethi PD. Quantitative analysis of drugs in pharmaceutical formulations, 3 ed., CBS publications, New Delhi, 2008.
Carstensen JT, Rhodes CT. Drug stability principles and practices, 3 CBS Publishers & distributors, New Delhi, 2005.
rd
ed.,
Yoshioka S, Stella VJ. Stability of drugs and dosage forms, Springer (India) Pvt. Ltd., New Delhi, 2006.
th
Banker GS, Rhodes CT. Modern Pharmaceutics, 4 Inc, New York, 2005.
W. Grimm - Stability testing of drug products.
ed., Marcel Dekker
Mazzo DJ. International stability testing. Eastern Press Pvt. Ltd.,
Bangalore, 1999. 13. Beckett AH, Stenlake JB. Practical pharmaceutical
th
chemistry, Part I & II., 4 2004.
ed., CBS Publishers & distributors, New Delhi,
Indian Pharmacopoeia. Controller of Publication. Delhi, 1996.
British Pharmacopoeia. British Pharmacopoeia Commission Office, London, 2008.
United States Pharmacopoeia. United States Pharmacopeial Convention, Inc, USA, 2003.
Encyclopaedia of Pharm. Technology, Vol I – III.
Wells J. I. Pharmaceutical Preformulation : The physicochemical properties of drug substances, Ellis Horwood Ltd. England, 1988.
NOVEL DRUG DELIVERY SYSTEMS (MIP 103T)
Scope
This course is designed to impart knowledge and skills necessary to train the students in the area of novel drug delivery systems.
Objective
On completion of this course it is expected that students will be able to understand,
The need, concept, design and evaluation of various customized, sustained and controlled release dosage forms.
To formulate and evaluate various novel drug delivery systems
THEORY 60 Hrs
1. Concept & Models for NDDS: Classification of rate controlled drug delivery systems (DDS), rate programmed release, activation modulated & feedback regulated DDS, effect of system parameters in controlled drug delivery, computation of desired release rate and dose for controlled release DDS, pharmacokinetic design for DDS – intermittent, zero order & first order release.
Carriers for Drug Delivery: Polymers / co-polymers- introduction, classification, characterization, polymerization techniques, application in CDDS / NDDS, biodegradable & natural polymers.
Study of Various DDS: Concepts, design, formulation & evaluation of controlled release oral DDS, Mucoadhesive DDS (buccal, nasal, pulmonary) Pulsatile, colon specific, liquid sustained release systems, Ocular delivery systems
Transdermal Drug Delivery Systems: Theory, design, formulation & evaluation including iontophoresis and other latest developments in skin delivery systems.
Sub Micron Cosmeceuticals: Biology, formulation science and evaluation of various cosmetics for skin, hair, nail, eye etc and it’s regulatory aspects.
12
Hrs
12
Hrs
08
Hrs
04
Hrs
Targeted Drug Delivery Systems: Importance, concept, biological process and events involved in drug targeting, design, formulation & evaluation, methods in drug targeting – nanoparticles, liposomes, niosomes, pharmacosomes, resealed erythrocytes, microspheres, magnetic microspheres. Specialized pharmaceutical emulsions – multiple emulsions, micro-emulsions.
Protein / Peptide Drug Delivery Systems: Concepts, delivery techniques, formulation, stability testing, causes of protein destabilization, stabilization methods.
Biotechnology in Drug Delivery Systems: Brief review of major areas-recombinant DNA technology, monoclonal antibodies, gene therapy.
New trends for Personalized Medicine: Introduction, Definition, Pharmacogenetics, Categories of Patients for Personalized Medicines: Customized drug delivery systems, Bioelectronic Medicines, 3D printing of pharmaceuticals, Telepharmacy.
REFERENCES
Novel Drug Delivery System, Y.W. Chein, Vol 50, Marcel Dekker, NY.
12
Hrs
06
Hrs
06
Hrs
Controlled Drug Delivery Systems, Robinson, Vol 29, Marcel Dekker, NY.
Transdermal Controlled Systemic Medications, YW Chein, Vol 31, Marcel Dekker, NY.
Bioadhesive DDS, E. Mathiowitz, Vol 98, Marcel Dekker, NY.
Nasal System Drug Delivery, K.S.E. Su, Vol 39, Marcel Dekker, NY.
Drug Delivery Devices, Vol 32, P Tyle Marcel Dekker, NY.
Polymers for Controlled Drug Delivery, P.J. Tarcha, CRC Press.
Pharmaceutical Biotechnology, Vyas, CBS, Delhi.
Biotechnology of Industrial Antibiotics, E.J. Vandamme, Marcel Dekker, NY.
Protein Formulation & Delivery, E.J. McNally, Vol 99, Marcel Dekker, NY.
Drug Targeting, M.H. Rubinstein, John Wiley, NY.
INTELLECTUAL PROPERTY RIGHTS (MIP 104T)
Scope
This course is designed to impart knowledge and skills necessary to train the students to be on par with the routine of Industrial activities in drug regulatory affairs
Objectives
On completion of this course it is expected that students will be able to understand,
Assist in Regulatory Audit process.
Establish regulatory guidelines for drug and drug products
The Regulatory requirements for contract research organization
THEORY 60 Hrs
1. Definition, Need for patenting, Types of Patents, Conditions to be satisfied by an invention to be patentable, Introduction to patent search. Parts of patents. Filling of patents. The essential elements of patent; Guidelines for preparation of laboratory note book, Non-obviousness in Patent.
12 Hrs
2 Role of GATT, TRIPS, and WIPO 12 Hrs
3 Brief introduction to Trademark protection and WHO Patents. IPR’s and its types, Major bodies regulating Indian Pharmaceutical sector.
4 Brief introduction to CDSCO. WHO, USFDA, EMEA, TGA, MHRA, MCC, ANVISA
5 Regulatory requirements for contract research organization. Regulations for Biosimilars.
12 Hrs
12 Hrs
12 Hrs
REFERENCES :
Pharmaceutical Process Validation: By Fra R. Berry and Robert A. Nash, Vol 57, 2nd Edition
Applied Production and Operation Management By Evans, Anderson and Williams
GMP for pharmaceuticals Material Management by K.K. Ahuja Published by CBS publishers
ISO 9000-Norms and explanations
GMP for pharmaceuticals- Willing S.H. Marcel and Dekker
INDUSTRIAL PHARMACY PRACTICAL - I (MIP 105P)
Analysis of pharmacopoeial compounds and their formulations by UV Vis spectrophotometer
Simultaneous estimation of multi component containing formulations by UV
spectrophotometry
Experiments based on HPLC / GC
Estimation of riboflavin/quinine sulphate by fluorimetry
Estimation of sodium/potassium by flame photometry
Effect of surfactants on the solubility of drugs.
Effect of pH on the solubility of drugs.
Stability testing of solution and solid dosage forms for photo degradation..
o o
Stability studies of drugs in dosage forms at 25 RH.
C, 60% RH and 40 C, 75%
Compatibility evaluation of drugs and excipients (DSC & FTIR). 11.Preparation and evaluation of different polymeric membranes. 12.Formulation and evaluation of sustained release oral matrix tablet/ oral
reservoir system.
Formulation and evaluation of microspheres / microcapsules. 14.Formulation and evaluation of transdermal drug delivery systems.
Design and evaluation of face wash, body- wash, creams, lotions, shampoo, toothpaste, lipstick.
Electrophoresis of protein solution.
Preparation and evaluation of Liposome delivery system.
INDUSTRIALPHARMACY(MIP)
MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES (MIP 101T)
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
UV-Visible spectroscopy: Introduction, Theory, Laws, Instrumentation 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.
NMR spectroscopy: Quantum numbers and their role in NMR, Principle, 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.
11
Hrs
11
Hrs
Mass Spectroscopy: Principle, Theory, Instrumentation of Mass 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
Chromatography: Principle, apparatus, instrumentation, chromatographic parameters, factors affecting resolution and applications of the following:
Paper chromatography b) Thin Layer chromatography
c) Ion exchange chromatography d) Column chromatography
e) Gas chromatography f) High Performance Liquid chromatography
g) Affinity chromatography
Electrophoresis: Principle, Instrumentation, Working conditions, factors affecting separation and applications of the following:
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: Radioimmunology assay (RIA), ELISA (Theory & practical) and knowledge on Bioluminescence assays.
11
Hrs
11
Hrs
11
Hrs
Hrs
REFERENCES
1. Spectrometric Identification of Organic compounds - Robert M Silverstein,
th
edition, John Wiley & Sons, 2004.
Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler, Timothy A. Nieman, 5th edition, Eastern press , Bangalore, 1998.
t h
Instrumental methods of analysis – Willards, 7 edition, CBS publishers.
th
Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4 edition, CBS Publishers, New Delhi, 1997.
Organic Spectroscopy - William Kemp, 3rd edition, ELBS, 1991.
Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi, 3rd Edition, CBS Publishers, New Delhi, 1997.
Pharmaceutical Analysis- Modern methods – Part B - J W Munson, Volume 11, Marcel Dekker Series
PHARMACEUTICAL FORMULATION DEVELOPMENT (MIP 102T)
Scope
This course is designed to impart knowledge and skills necessary to train the students on par with the routine of Industrial activities in R&D and F&D.
Objectives
On completion of this course it is expected that students will be able to understand-
The scheduled activities in a Pharmaceutical firm.
The pre formulation studies of pilot batches of pharmaceutical industry.
The significance of dissolution and product stability
THEORY 60 Hrs
1. Preformulation Studies: Molecular optimization of APIs (drug substances), crystal morphology and variations, powder flow, structure modification, drug-excipient compatibility studies, methods of determination.
Formulation Additives: Study of different formulation additives, factors influencing their incorporation, role of formulation development and processing, new developments in excipient science. Design of experiments – factorial design for product and process development.
Solubility: Importance, experimental determination, phase- solubility analysis, pH-solubility profile, solubility techniques to improve solubility and utilization of analytical methods – cosolvency, salt formation, complexation, solid dispersion, micellar solubilization and hydrotropy.
Dissolution: Theories, mechanisms of dissolution, in-vitro dissolution testing models – sink and non-sink. Factors influencing dissolution and intrinsic dissolution studies. Dissolution test apparatus – designs, dissolution testing for conventional and controlled release products. Data handling and correction factor. Biorelevent media, in-vitro and in-vivo correlations, levels of correlations.
12
Hrs
12
Hrs
12
Hrs
12
Hrs
Product Stability: Degradation kinetics, mechanisms, stability testing of drugs and pharmaceuticals, factors influencing-media effects and pH effects, accelerated stability studies, interpretation of kinetic data (API & tablets). Solid state stability and shelf life assignment. Stability protocols, reports and ICH guidelines.
12
Hrs
REFERENCES
Lachman L, Lieberman HA, Kanig JL. The Theory and Practice Of
rd
Industrial Pharmacy, 3 ed., Varghese Publishers, Mumbai 1991.
th
Sinko PJ. Martin's physical pharmacy and pharmaceutical sciences, 5 ed., B.I. Publications Pvt. Ltd, Noida, 2006.
Lieberman HA, Lachman L, Schwartz JB. Pharmaceutical dosage forms:
nd
tablets Vol. I-III, 2 ed., CBS Publishers & distributors, New Delhi, 2005.
Conners KA. A Text book of pharmaceutical analysi Wells JI. Pharmaceutical preformulation: The physicochemical properties of drug substances. Ellis Horwood Ltd., England, 1998.
Yalkowsky SH. Techniques of solubilization of drugs. Vol-12. Marcel Dekker Inc., New York, 1981
Dressman J, Kramer J. Pharmaceutical dissolution testing. Saurah printer pvt. Ltd., New Delhi,2005.
rd
Sethi PD. Quantitative analysis of drugs in pharmaceutical formulations, 3 ed., CBS publications, New Delhi, 2008.
Carstensen JT, Rhodes CT. Drug stability principles and practices, 3 CBS Publishers & distributors, New Delhi, 2005.
rd
ed.,
Yoshioka S, Stella VJ. Stability of drugs and dosage forms, Springer (India) Pvt. Ltd., New Delhi, 2006.
th
Banker GS, Rhodes CT. Modern Pharmaceutics, 4 Inc, New York, 2005.
W. Grimm - Stability testing of drug products.
ed., Marcel Dekker
Mazzo DJ. International stability testing. Eastern Press Pvt. Ltd.,
Bangalore, 1999. 13. Beckett AH, Stenlake JB. Practical pharmaceutical
th
chemistry, Part I & II., 4 2004.
ed., CBS Publishers & distributors, New Delhi,
Indian Pharmacopoeia. Controller of Publication. Delhi, 1996.
British Pharmacopoeia. British Pharmacopoeia Commission Office, London, 2008.
United States Pharmacopoeia. United States Pharmacopeial Convention, Inc, USA, 2003.
Encyclopaedia of Pharm. Technology, Vol I – III.
Wells J. I. Pharmaceutical Preformulation : The physicochemical properties of drug substances, Ellis Horwood Ltd. England, 1988.
NOVEL DRUG DELIVERY SYSTEMS (MIP 103T)
Scope
This course is designed to impart knowledge and skills necessary to train the students in the area of novel drug delivery systems.
Objective
On completion of this course it is expected that students will be able to understand,
The need, concept, design and evaluation of various customized, sustained and controlled release dosage forms.
To formulate and evaluate various novel drug delivery systems
THEORY 60 Hrs
1. Concept & Models for NDDS: Classification of rate controlled drug delivery systems (DDS), rate programmed release, activation modulated & feedback regulated DDS, effect of system parameters in controlled drug delivery, computation of desired release rate and dose for controlled release DDS, pharmacokinetic design for DDS – intermittent, zero order & first order release.
Carriers for Drug Delivery: Polymers / co-polymers- introduction, classification, characterization, polymerization techniques, application in CDDS / NDDS, biodegradable & natural polymers.
Study of Various DDS: Concepts, design, formulation & evaluation of controlled release oral DDS, Mucoadhesive DDS (buccal, nasal, pulmonary) Pulsatile, colon specific, liquid sustained release systems, Ocular delivery systems
Transdermal Drug Delivery Systems: Theory, design, formulation & evaluation including iontophoresis and other latest developments in skin delivery systems.
Sub Micron Cosmeceuticals: Biology, formulation science and evaluation of various cosmetics for skin, hair, nail, eye etc and it’s regulatory aspects.
12
Hrs
12
Hrs
08
Hrs
04
Hrs
Targeted Drug Delivery Systems: Importance, concept, biological process and events involved in drug targeting, design, formulation & evaluation, methods in drug targeting – nanoparticles, liposomes, niosomes, pharmacosomes, resealed erythrocytes, microspheres, magnetic microspheres. Specialized pharmaceutical emulsions – multiple emulsions, micro-emulsions.
Protein / Peptide Drug Delivery Systems: Concepts, delivery techniques, formulation, stability testing, causes of protein destabilization, stabilization methods.
Biotechnology in Drug Delivery Systems: Brief review of major areas-recombinant DNA technology, monoclonal antibodies, gene therapy.
New trends for Personalized Medicine: Introduction, Definition, Pharmacogenetics, Categories of Patients for Personalized Medicines: Customized drug delivery systems, Bioelectronic Medicines, 3D printing of pharmaceuticals, Telepharmacy.
REFERENCES
Novel Drug Delivery System, Y.W. Chein, Vol 50, Marcel Dekker, NY.
12
Hrs
06
Hrs
06
Hrs
Controlled Drug Delivery Systems, Robinson, Vol 29, Marcel Dekker, NY.
Transdermal Controlled Systemic Medications, YW Chein, Vol 31, Marcel Dekker, NY.
Bioadhesive DDS, E. Mathiowitz, Vol 98, Marcel Dekker, NY.
Nasal System Drug Delivery, K.S.E. Su, Vol 39, Marcel Dekker, NY.
Drug Delivery Devices, Vol 32, P Tyle Marcel Dekker, NY.
Polymers for Controlled Drug Delivery, P.J. Tarcha, CRC Press.
Pharmaceutical Biotechnology, Vyas, CBS, Delhi.
Biotechnology of Industrial Antibiotics, E.J. Vandamme, Marcel Dekker, NY.
Protein Formulation & Delivery, E.J. McNally, Vol 99, Marcel Dekker, NY.
Drug Targeting, M.H. Rubinstein, John Wiley, NY.
INTELLECTUAL PROPERTY RIGHTS (MIP 104T)
Scope
This course is designed to impart knowledge and skills necessary to train the students to be on par with the routine of Industrial activities in drug regulatory affairs
Objectives
On completion of this course it is expected that students will be able to understand,
Assist in Regulatory Audit process.
Establish regulatory guidelines for drug and drug products
The Regulatory requirements for contract research organization
THEORY 60 Hrs
1. Definition, Need for patenting, Types of Patents, Conditions to be satisfied by an invention to be patentable, Introduction to patent search. Parts of patents. Filling of patents. The essential elements of patent; Guidelines for preparation of laboratory note book, Non-obviousness in Patent.
12 Hrs
2 Role of GATT, TRIPS, and WIPO 12 Hrs
3 Brief introduction to Trademark protection and WHO Patents. IPR’s and its types, Major bodies regulating Indian Pharmaceutical sector.
4 Brief introduction to CDSCO. WHO, USFDA, EMEA, TGA, MHRA, MCC, ANVISA
5 Regulatory requirements for contract research organization. Regulations for Biosimilars.
12 Hrs
12 Hrs
12 Hrs
REFERENCES :
Pharmaceutical Process Validation: By Fra R. Berry and Robert A. Nash, Vol 57, 2nd Edition
Applied Production and Operation Management By Evans, Anderson and Williams
GMP for pharmaceuticals Material Management by K.K. Ahuja Published by CBS publishers
ISO 9000-Norms and explanations
GMP for pharmaceuticals- Willing S.H. Marcel and Dekker
INDUSTRIAL PHARMACY PRACTICAL - I (MIP 105P)
Analysis of pharmacopoeial compounds and their formulations by UV Vis spectrophotometer
Simultaneous estimation of multi component containing formulations by UV
spectrophotometry
Experiments based on HPLC / GC
Estimation of riboflavin/quinine sulphate by fluorimetry
Estimation of sodium/potassium by flame photometry
Effect of surfactants on the solubility of drugs.
Effect of pH on the solubility of drugs.
Stability testing of solution and solid dosage forms for photo degradation..
o o
Stability studies of drugs in dosage forms at 25 RH.
C, 60% RH and 40 C, 75%
Compatibility evaluation of drugs and excipients (DSC & FTIR). 11.Preparation and evaluation of different polymeric membranes. 12.Formulation and evaluation of sustained release oral matrix tablet/ oral
reservoir system.
Formulation and evaluation of microspheres / microcapsules. 14.Formulation and evaluation of transdermal drug delivery systems.
Design and evaluation of face wash, body- wash, creams, lotions, shampoo, toothpaste, lipstick.
Electrophoresis of protein solution.
Preparation and evaluation of Liposome delivery system.