- Scope: This subject deals with the application of instrumental methods in qualitative and quantitative analysis of drugs. This subject is designed to impart a fundamental knowledge on the principles and instrumentation of spectroscopic and chromatographic technique. This also emphasizes on theoretical and practical knowledge on modern analytical instruments that are used for drug testing.
Objectives: Upon completion of the course the student shall be able to .
1. Understand the interaction of matter with electromagnetic radiations and its applications in drug analysis.
2. Understand the chromatographic separation and analysis of drugs.
3. Perform quantitative & qualitative analysis of drugs using various analytical
instruments.
UNIT –I 10 Hours UV Visible spectroscopy Electronic transitions, chromophores, auxochromes, spectral shifts, solvent effect on absorption spectra, Beer and Lambert’s law, Derivation and deviations. Instrumentation - Sources of radiation, wavelength selectors, sample cells, detectors- Photo tube, Photomultiplier tube, Photo voltaic cell, Silicon Photodiode. Applications - Spectrophotometric titrations, Single component and multi component analysis Fluorimetry Theory, Concepts of singlet, doublet and triplet electronic states, internal and external conversions, factors affecting fluorescence, quenching, instrumentation and applications .
UNIT –II 10 Hours IR spectroscopy Introduction, fundamental modes of vibrations in poly atomic molecules, sample handling, factors affecting vibrations Instrumentation - Sources of radiation, wavelength selectors, detectors - Golay cell, Bolometer, Thermocouple, Thermister, Pyroelectric detector and applications Flame Photometry-Principle, interferences, instrumentation and applications 144 Atomic absorption spectroscopy- Principle, interferences, instrumentation and applications Nepheloturbidometry- Principle, instrumentation and applications
UNIT –III 10 Hours Introduction to chromatography Adsorption and partition column chromatography-Methodology, advantages, disadvantages and applications. Thin layer chromatography- Introduction, Principle, Methodology, Rf values, advantages, disadvantages and applications. Paper chromatography-Introduction, methodology, development techniques, advantages, disadvantages and applications Electrophoresis– Introduction, factors affecting electrophoretic mobility, Techniques of paper, gel, capillary electrophoresis, applications.
UNIT –IV 08 Hours Gas chromatography - Introduction, theory, instrumentation, derivatization, temperature programming, advantages, disadvantages and applications High performance liquid chromatography (HPLC)-Introduction, theory, instrumentation, advantages and applications.
UNIT –V 07 Hours
Ion exchange chromatography- Introduction, classification, ion exchange resins, properties, mechanism of ion exchange process, factors affecting ion exchange, methodology and applications
Gel chromatography- Introduction, theory, instrumentation and applications
Affinity chromatography- Introduction, theory, instrumentation and applications.
Recommended Books (Latest Editions)
1. Instrumental Methods of Chemical Analysis by B.K Sharma
2. Organic spectroscopy by Y.R Sharma
3. Text book of Pharmaceutical Analysis by Kenneth A. Connors
4. Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel
5. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake
6. Organic Chemistry by I. L. Finar
7. Organic spectroscopy by William Kemp
8. Quantitative Analysis of Drugs by D. C. Garrett
9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi
10. Spectrophotometric identification of Organic Compounds by Silverstein
Scope: This course is designed to impart fundamental knowledge on pharmaceutical product development and translation from laboratory to market Objectives: Upon completion of the course, the student shall be able to:
1. Know the process of pilot plant and scale up of pharmaceutical dosage forms.
2. Understand the process of technology transfer from lab scale to commercial batch.
3. Know different Laws and Acts that regulate pharmaceutical industry
.4. Understand the approval process and regulatory requirements for drug products Course Content:
UNIT-I 10 Hours Pilot plant scale up techniques: General considerations - including significance of personnel requirements, space requirements, raw materials, Pilot plant scale up considerations for solids, liquid orals, semi solids and relevant documentation, SUPAC guidelines, Introduction to platform technology.
UNIT-II 10 Hours Technology development and transfer: WHO guidelines for Technology Transfer(TT): Terminology, Technology transfer protocol, Quality risk management, Transfer from R & D to production (Process, packaging and cleaning), Granularity of TT Process (API, excipients, finished products, packaging materials) Documentation, Premises and equipments, qualification and validation, quality control, analytical method transfer, Approved regulatory bodies and agencies, Commercialization - practical aspects and problems (case studies), TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE / SIDBI; TT related documentation - confidentiality agreement, licensing, MoUs, legal issues.
UNIT-III 10 Hours Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatory authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals Regulatory requirements for drug approval: Drug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies. 147.
UNIT-IV 08 Hours Quality management systems: Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP.
UNIT-V 07 Hours Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs.
Recommended Books: (Latest Editions)
1. Regulatory Affairs from Wikipedia, the free encyclopedia modified on 7th April available at http,//en.wikipedia.org/wiki/Regulatory_ Affairs.
2. International Regulatory Affairs Updates, 2005. available at http://www.iraup.com/about.php
3. Douglas J Pisano and David S. Mantus. Text book of FDA Regulatory Affairs A Guide for Prescription Drugs, Medical Devices, and Biologics’ Second Edition.
4. Regulatory Affairs brought by learning plus, inc. available at
http.//www.cgmp.com/ra.htm
- Teacher: Dr Nikhar Vishwakarma
Unit-I
Controlled drug delivery systems: Introduction, terminology/definitions and
rationale,advantages, disadvantages, selection of drug candidates. Approaches
to design controlled release formulations based on diffusion, dissolution and ion
exchange principles. Physicochemical and biological properties of drugs
relevant to controlled release formulations
Polymers: Introduction, classification, properties, advantages and application of
polymers in formulation of controlled release drug delivery systems.
Microencapsulation: Definition, advantages and disadvantages, microspheres
/microcapsules, microparticles, methods of microencapsulation, applications
Mucosal Drug Delivery system: Introduction, Principles of bioadhesion /
mucoadhesion, concepts, advantages and disadvantages, transmucosal
permeability and formulation considerations of buccal delivery systems
Implantable Drug Delivery Systems:Introduction, advantages and
disadvantages, concept of implantsand osmotic pump
Unit-III
Transdermal Drug Delivery Systems: Introduction, Permeation through skin,
factors affecting permeation, permeation enhancers, basic components of
TDDS, formulation approaches
Gastroretentive drug delivery systems: Introduction, advantages,
disadvantages, approaches for GRDDS – Floating, high density systems,
inflatable and gastroadhesive systems and their applications
Nasopulmonary drug delivery system: Introduction to Nasal and Pulmonary
routes of drug delivery, Formulation of Inhalers (dry powder and metered dose),
nasal sprays, nebulizers
Unit-IV
Targeted drug Delivery: Concepts and approaches advantages and
disadvantages, introduction to liposomes, niosomes, nanoparticles, monoclonal
antibodies and their applications
Unit-V
Ocular Drug Delivery Systems: Introduction, intra ocular barriers and
methods to overcome –Preliminary study, ocular formulations and ocuserts
Intrauterine Drug Delivery Systems: Introduction, advantages and
disadvantages, development of intra uterine devices (IUDs) and applications
- Teacher: Devendra Lodhi