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M.Pharm Industrial Pharmacy Syllabus

Industrial Pharmacy is the M.Pharm specialisation on pharmaceutical formulation development, production and technology transfer in industry. This page gives the complete syllabus of the branch as prescribed by the Pharmacy Council of India, subject by subject and unit by unit.

Source: Pharmacy Council of India (PCI), The Revised Regulations for the Master of Pharmacy Degree Program, Credit Based Semester System, and the M.Pharm syllabus prescribed by the Pharmacy Council of India. The syllabus below is reproduced from the PCI syllabus, unit by unit.

Semester 1

MIP101T Modern Pharmaceutical Analytical Techniques

Unit 1: Spectroscopy I

Unit 2: 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.

Unit 3: 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, metastable ions, isotopic peaks, applications of mass spectroscopy.

Unit 4: Chromatography

Principle, apparatus, instrumentation, chromatographic parameters, factors affecting resolution and applications of the following: a) Paper chromatography, b) Thin layer chromatography, c) Ion exchange chromatography, d) Column chromatography, e) Gas chromatography, f) High performance liquid chromatography, g) Affinity chromatography.

Unit 5: Electrophoresis and X-ray crystallography

Unit 6: Immunological assays

Immunological assays: RIA (radio immunoassay), ELISA, bioluminescence assays.

MIP102T Pharmaceutical Formulation Development

Unit 1: Preformulation Studies

Preformulation Studies: Molecular optimization of APIs (drug substances), crystal morphology and variations, powder flow, structure modification, drug-excipient compatibility studies, methods of determination.

Unit 2: Formulation Additives

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.

Unit 3: Solubility

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.

Unit 4: Dissolution

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. Biorelevant media, in-vitro and in-vivo correlations, levels of correlations.

Unit 5: Product Stability

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.

MIP103T Novel Drug Delivery Systems

Unit 1: Concept and Models for NDDS

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.

Unit 2: Study of Various DDS

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.

Unit 3: Transdermal Drug Delivery Systems

Transdermal Drug Delivery Systems: Theory, design, formulation & evaluation including iontophoresis and other latest developments in skin delivery systems.

Unit 4: Sub Micron Cosmeceuticals

Sub Micron Cosmeceuticals: Biology, formulation science and evaluation of various cosmetics for skin, hair, nail, eye etc and its regulatory aspects.

Unit 5: Targeted Drug Delivery Systems

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.

Unit 6: Protein / Peptide Drug Delivery Systems

Protein / Peptide Drug Delivery Systems: Concepts, delivery techniques, formulation, stability testing, causes of protein destabilization, stabilization methods.

Unit 7: Biotechnology in Drug Delivery Systems

Biotechnology in Drug Delivery Systems: Brief review of major areas, recombinant DNA technology, monoclonal antibodies, gene therapy.

Unit 8: New trends for Personalized Medicine

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.

MIP104T Intellectual Property Rights

Unit 1: Patents

Definition, Need for patenting, Types of Patents, Conditions to be satisfied by an invention to be patentable, Introduction to patent search. Parts of patents. Filing of patents. The essential elements of patent; Guidelines for preparation of laboratory note book, Non-obviousness in Patent.

Unit 2: GATT, TRIPS and WIPO

Role of GATT, TRIPS, and WIPO.

Unit 3: Trademark protection and regulatory bodies

Brief introduction to Trademark protection and WHO Patents. IPRs and its types, Major bodies regulating Indian Pharmaceutical sector.

Unit 4: Regulatory authorities

Brief introduction to CDSCO, WHO, USFDA, EMEA, TGA, MHRA, MCC, ANVISA.

Unit 5: Contract research organizations and biosimilars

Regulatory requirements for contract research organization. Regulations for Biosimilars.

Practicals and Seminar

Semester 2

MIP201T Advanced Biopharmaceutics and Pharmacokinetics

Unit 1: Drug Absorption From The Gastrointestinal Tract

Drug Absorption From The Gastrointestinal Tract: Gastrointestinal tract, Mechanism of drug absorption, Factors affecting, pH-partition theory, Formulation and physicochemical factors: Dissolution rate, Dissolution process, Noyes-Whitney equation and drug dissolution, Factors affecting the dissolution rate. Gastrointestinal absorption: role of the dosage form: Solution (elixir, syrup and solution) as a dosage form, Suspension as a dosage form, Capsule as a dosage form, Tablet as a dosage form, Dissolution methods, Formulation and processing factors, Correlation of in vivo data with in vitro dissolution data. Transport model: Permeability-Solubility-Charge State and the pH Partition Hypothesis, Properties of the Gastrointestinal Tract (GIT), pH Microclimate Intracellular pH Environment, Tight-Junction Complex. Solubility: Experimental methods. Permeability: In-vitro, in-situ and In-vivo methods.

Unit 2: Biopharmaceutic Considerations in Drug Product Design and In Vitro Drug Product Performance

Biopharmaceutic Considerations in Drug Product Design and In Vitro Drug Product Performance: Introduction, Biopharmaceutic Factors Affecting Drug Bioavailability, Rate Limiting Steps in Drug Absorption, Physicochemical Nature of the Drug Formulation Factors Affecting Drug Product Performance, In Vitro: Dissolution and Drug Release Testing, Compendial Methods of Dissolution, Alternative Methods of Dissolution Testing, Meeting Dissolution Requirements, Problems of Variable Control in Dissolution Testing Performance of Drug Products: In Vitro-In Vivo Correlation, Dissolution Profile Comparisons, Drug Product Stability, Considerations in the Design of a Drug Product.

Unit 3: Pharmacokinetics

Pharmacokinetics: Basic considerations, Pharmacokinetic models, Compartment modeling: One compartment model, IV bolus, IV infusion, Extra-vascular; Multi Compartment model: Two compartment model in brief, Non-Linear Pharmacokinetics: Cause of non-linearity, Michaelis-Menten equation, Estimation Kmax and Vmax. Drug interactions: Introduction, The effect of protein-binding interactions, The effect of tissue-binding interactions, Cytochrome P450-based drug interactions, Drug interactions linked to transporters.

Unit 4: Drug Product Performance, In Vivo: Bioavailability and Bioequivalence

Drug Product Performance, In Vivo: Bioavailability and Bioequivalence: Drug Product Performance, Purpose of Bioavailability Studies, Relative and Absolute Availability, Methods for Assessing Bioavailability, Bioequivalence Studies, Design and Evaluation of Bioequivalence Studies, Study Designs, Crossover Study Designs, Evaluation of the Data, Bioequivalence Example, Study Submission and Drug Review Process, The Biopharmaceutics Classification System, Generic Biologics (Biosimilar Drug Products), Clinical Significance of Bioequivalence Studies, Special Concerns in Bioavailability and Bioequivalence Studies, Generic Substitution.

Unit 5: Application of Pharmacokinetics

Application of Pharmacokinetics: Modified-Release Drug Products, Targeted Drug Delivery Systems and Biotechnological Products. Relationship between Pharmacokinetics including Pharmacodynamics: Generation of a pharmacokinetic-pharmacodynamic (PKPD) equation, Pharmacokinetic and pharmacodynamic interactions. Pharmacokinetics and pharmacodynamics of biotechnology drugs: Introduction, Proteins and peptides, Monoclonal antibodies, Oligonucleotides, Vaccines (immunotherapy), Gene therapies.

MIP202T Scale up and Technology Transfer

Unit 1: Pilot plant design and scale up

Pilot plant design: Basic requirements for design, facility, equipment selection, for tablets, capsules, liquid orals, parenteral and semisolid preparations. Scale up: Importance, Technology transfer from R & D to pilot plant to plant scale, process scale up for tablets, capsules, liquid orals, semisolids, parenteral, NDDS products, stress on formula, equipments, product uniformity, stability, raw materials, physical layout, input, in-process and finished product specifications, problems encountered during transfer of technology.

Unit 2: Validation

Validation: General concepts, types, procedures & protocols, documentation, VMF. Analytical method validation, cleaning validation and vendor qualification.

Unit 3: Equipment Qualification

Equipment Qualification: Importance, IQ, OQ, PQ for equipments, autoclave, DHS, membrane filter, rapid mixer granulator, cone blender, FBD, tablet compression machine, liquid filling and sealing machine. Aseptic room validation.

Unit 4: Process validation

Process validation: Importance, validation of mixing, granulation, drying, compression, tablet coating, liquid filling and sealing, sterilization, water process systems, environmental control.

Unit 5: Industrial safety

Industrial safety: Hazards, fire, mechanical, electrical, chemical and pharmaceutical, Monitoring & prevention systems, industrial effluent testing & treatment. Control of environmental pollution.

MIP203T Pharmaceutical Production Technology

Unit 1: Improved Tablet Production

Improved Tablet Production: Tablet production process, unit operation improvements, granulation and pelletization equipments, continuous and batch mixing, rapid mixing granulators, rota granulators, spheronizers and marumerisers, and other specialized granulation and drying equipments. Problems encountered. Coating Technology: Process, equipments, particle coating, fluidized bed coating, and application techniques. Problems encountered.

Unit 2: Parenteral Production

Parenteral Production: Area planning & environmental control, wall and floor treatment, fixtures and machineries, change rooms, personnel flow, utilities & utilities equipment location, engineering and maintenance.

Unit 3: Lyophilization & Spray drying Technology

Lyophilization & Spray drying Technology: Principles, process, freeze drying and spray drying equipments.

Unit 4: Capsule Production

Capsule Production: Production process, improved capsule manufacturing and filling machines for hard and soft gelatin capsules. Layout and problems encountered. Disperse Systems Production: Production processes, applications of mixers, mills, disperse equipments including fine solids dispersion, problems encountered. Packaging Technology: Types of packaging materials, machinery, labeling, and package printing for different dosage forms.

Unit 5: Air Handling Systems

Air Handling Systems: Study of AHUs, humidity & temperature control, air filtration systems, dust collectors. Water Treatment Process: Techniques and maintenance, RO, DM, ultra-filtration, WFI.

MIP204T Entrepreneurship Management

Unit 1: Conceptual Frame Work

Conceptual Frame Work: Concept need and process in entrepreneurship development. Role of enterprise in national and global economy. Types of enterprise, Merits and Demerits. Government policies and schemes for enterprise development. Institutional support in enterprise development and management.

Unit 2: Entrepreneur

Entrepreneur: Entrepreneurial motivation, dynamics of motivation. Entrepreneurial competency, Concepts. Developing Entrepreneurial competencies, requirements and understanding the process of entrepreneurship development, self-awareness, interpersonal skills, creativity, assertiveness, achievement, factors affecting entrepreneur role.

Unit 3: Launching And Organising An Enterprise

Launching And Organising An Enterprise: Environment scanning, Information, sources, schemes of assistance, problems. Enterprise selection, market assessment, enterprise feasibility study, SWOT Analysis. Resource mobilisation, finance, technology, raw material, site and manpower. Costing and marketing management and quality control. Feedback, monitoring and evaluation.

Unit 4: Growth Strategies And Networking

Growth Strategies And Networking: Performance appraisal and assessment. Profitability and control measures, demands and challenges. Need for diversification. Future Growth, Techniques of expansion and diversification, vision strategies. Concept and dynamics. Methods, Joint venture, co-ordination and feasibility study.

Unit 5: Preparing Project Proposal To Start On New Enterprise

Preparing Project Proposal To Start On New Enterprise: Project work, Feasibility report; Planning, resource mobilisation and implementation.

Practicals and Seminar

Semester 3 and 4

Semester 3 and Semester 4 are common to all M.Pharm specialisations: Research Methodology and Biostatistics (MRM301T), Journal Club, Discussion / Presentation and Research Work. See the M.Pharm common syllabus page for the full common syllabus.