M.Pharm Pharmaceutics Syllabus
Pharmaceutics is the M.Pharm specialisation on dosage forms and drug delivery systems. 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
MPH101T Modern Pharmaceutical Analytical Techniques
Subject notes: MPH101T Modern Pharmaceutical Analytical Techniques notes
Unit 1: Spectroscopy I
- a. UV-Visible spectroscopy: introduction, theory, laws, instrumentation associated with UV-Visible spectroscopy, choice of solvents and solvent effect and applications of UV-Visible spectroscopy.
- b. 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.
- c. Spectrofluorimetry: theory of fluorescence, factors affecting fluorescence, quenchers, instrumentation and applications of fluorescence spectrophotometer.
- d. Flame emission spectroscopy and atomic absorption spectroscopy: principle, instrumentation, interferences and applications.
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
- a. Electrophoresis: principle, instrumentation, working conditions, factors affecting separation and applications of the following: paper electrophoresis, gel electrophoresis, capillary electrophoresis, zone electrophoresis, moving boundary electrophoresis, isoelectric focusing.
- b. X-ray crystallography: production of X-rays, different X-ray diffraction methods, Bragg law, rotating crystal technique, X-ray powder technique, types of crystals, applications of X-ray diffraction.
Unit 6: Immunological assays
Immunological assays: RIA (radio immunoassay), ELISA, bioluminescence assays.
MPH102T Drug Delivery System
Subject notes: MPH102T Drug Delivery System notes
Unit 1: Sustained Release and Controlled Release Formulations, Polymers, Personalized Medicine
Sustained Release (SR) and Controlled Release (CR) formulations: introduction and basic concepts, advantages and disadvantages, factors influencing, physicochemical and biological approaches for SR/CR formulation, mechanism of drug delivery from SR/CR formulation. Polymers: introduction, definition, classification, properties and application. Dosage Forms for Personalized Medicine: introduction, definition, pharmacogenetics, categories of patients for personalized medicines, customized drug delivery systems, bioelectronic medicines, 3D printing of pharmaceuticals, telepharmacy.
Unit 2: Rate Controlled Drug Delivery Systems
Rate Controlled Drug Delivery Systems: principles and fundamentals, types, activation modulated drug delivery systems; mechanically activated, pH activated, enzyme activated and osmotic activated drug delivery systems. Feedback regulated drug delivery systems: principles and fundamentals.
Unit 3: Gastro-Retentive and Buccal Drug Delivery Systems
Gastro-Retentive Drug Delivery Systems: principle, concepts, advantages and disadvantages, modulation of GI transit time, approaches to extend GI transit. Buccal Drug Delivery Systems: principle of mucoadhesion, advantages and disadvantages, mechanism of drug permeation, methods of formulation and its evaluations.
Unit 4: Ocular Drug Delivery Systems
Ocular Drug Delivery Systems: barriers of drug permeation, methods to overcome barriers.
Unit 5: Transdermal Drug Delivery Systems
Transdermal Drug Delivery Systems: structure of skin and barriers, penetration enhancers, transdermal drug delivery systems, formulation and evaluation.
Unit 6: Protein and Peptide Delivery
Protein and Peptide Delivery: barriers for protein delivery, formulation and evaluation of delivery systems of proteins and other macromolecules.
Unit 7: Vaccine Delivery Systems
Vaccine delivery systems: vaccines, uptake of antigens, single shot vaccines, mucosal and transdermal delivery of vaccines.
MPH103T Modern Pharmaceutics
Subject notes: MPH103T Modern Pharmaceutics notes
Unit 1: Preformulation Concepts, Disperse Systems, Parenterals and Optimization Techniques
a. Preformulation Concepts: drug excipient interactions, different methods; kinetics of stability; stability testing. Theories of dispersion and pharmaceutical dispersion (emulsion and suspension, SMEDDS): preparation and stability. Large and small volume parenterals: physiological and formulation considerations, manufacturing and evaluation. b. Optimization techniques in Pharmaceutical Formulation: concept and parameters of optimization, optimization techniques in pharmaceutical formulation and processing, statistical design, response surface method, contour designs, factorial designs and application in formulation.
Unit 2: Validation
Validation: introduction to pharmaceutical validation, scope and merits of validation, validation and calibration of master plan, ICH and WHO guidelines for calibration and validation of equipments, validation of specific dosage form, types of validation. Government regulation, manufacturing process model, URS, DQ, IQ, OQ and PQ of facilities.
Unit 3: cGMP and Industrial Management
cGMP and Industrial Management: objectives and policies of current good manufacturing practices, layout of buildings, services, equipments and their maintenance. Production management: production organization, materials management, handling and transportation, inventory management and control, production and planning control, sales forecasting, budget and cost control, industrial and personal relationship. Concept of Total Quality Management.
Unit 4: Compression and Compaction
Compression and compaction: physics of tablet compression, compression, consolidation, effect of friction, distribution of forces, compaction profiles. Solubility.
Unit 5: Consolidation Parameters and Pharmaceutical Statistics
Study of consolidation parameters: diffusion parameters, dissolution parameters and pharmacokinetic parameters, Heckel plots, similarity factors f2 and f1, Higuchi and Peppas plot. Linearity, concept of significance, standard deviation, chi square test, Student's t test, ANOVA test.
MPH104T Regulatory Affair
Subject notes: MPH104T Regulatory Affair notes
Unit 1: Documentation in Pharmaceutical Industry and Generic Drug Product Development
a. Documentation in Pharmaceutical industry: master formula record, DMF (Drug Master File), distribution records. Generic drugs product development: introduction, Hatch-Waxman act and amendments, CFR (Code of Federal Regulation), drug product performance, in-vitro, ANDA regulatory approval process, NDA approval process, BE and drug product assessment, in-vivo, scale up process approval changes, post marketing surveillance, outsourcing BA and BE to CRO. b. Regulatory requirement for product approval: API, biologics, novel therapies, obtaining NDA, ANDA for generic drugs, ways and means of US registration for foreign drugs.
Unit 2: Regulatory Requirements for Product Approval
Regulatory requirement for product approval: API, biologics, novel therapies, obtaining NDA, ANDA for generic drugs, ways and means of US registration for foreign drugs.
Unit 3: CMC, Post Approval Regulatory Affairs, CTD and ICH Guidelines
CMC, post approval regulatory affairs. Regulation for combination products and medical devices. CTD and eCTD format, industry and FDA liaison. ICH Guidelines of ICH-Q, S, E, M. Regulatory requirements of EU, MHRA, TGA and ROW countries.
Unit 4: Non Clinical Drug Development and Global Submissions
Non clinical drug development: global submission of IND, NDA, ANDA. Investigational medicinal products dossier (IMPD) and investigator brochure (IB).
Unit 5: Clinical Trials
Clinical trials: developing clinical trial protocols. Institutional review board / independent ethics committee: formulation and working procedures. Informed consent process and procedures. HIPAA, requirement to clinical study process, pharmacovigilance and safety monitoring in clinical trials.
Practicals and Seminar
- MPH105P Pharmaceutics Practical I
- Seminar/Assignment
Semester 2
MPH201T Molecular Pharmaceutics (Nano Tech and Targeted DDS)
Subject notes: MPH201T Molecular Pharmaceutics (Nano Tech and Targeted DDS) notes
Unit 1: Targeted Drug Delivery Systems
Targeted Drug Delivery Systems: concepts, events and biological process involved in drug targeting. Tumor targeting and brain specific delivery.
Unit 2: Targeting Methods, Nanoparticles and Liposomes
Targeting Methods: introduction, preparation and evaluation. Nanoparticles and Liposomes: types, preparation and evaluation.
Unit 3: Microcapsules, Microspheres and Vesicular and Related Carriers
Micro Capsules / Micro Spheres: types, preparation and evaluation. Monoclonal Antibodies: preparation and application. Preparation and application of Niosomes, Aquasomes, Phytosomes, Electrosomes.
Unit 4: Pulmonary and Intra Nasal Drug Delivery Systems
Pulmonary Drug Delivery Systems: aerosols, propellants, containers; types, preparation and evaluation. Intra Nasal Route Delivery systems: types, preparation and evaluation.
Unit 5: Nucleic Acid Based Therapeutic Delivery Systems
Nucleic acid based therapeutic delivery system: gene therapy, introduction (ex-vivo and in-vivo gene therapy). Potential target diseases for gene therapy (inherited disorder and cancer). Gene expression systems (viral and nonviral gene transfer). Liposomal gene delivery systems. Biodistribution and pharmacokinetics. Knowledge of therapeutic antisense molecules and aptamers as drugs of future.
MPH202T Advanced Biopharmaceutics and Pharmacokinetics
Subject notes: MPH202T Advanced Biopharmaceutics and Pharmacokinetics notes
Unit 1: Drug Absorption from the Gastrointestinal Tract
Gastrointestinal tract, mechanism of drug absorption, factors affecting drug absorption, pH-partition theory of drug absorption. 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.
Unit 2: 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
Basic considerations, pharmacokinetic models, compartment modeling: one compartment model, IV bolus, IV infusion, extravascular. Multi compartment model: two compartment model in brief. Nonlinear pharmacokinetics: cause of nonlinearity, Michaelis-Menten equation, estimation of Km 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, purpose of bioavailability studies, relative and absolute bioavailability, 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. Biopharmaceutics classification system, methods. Permeability: in vitro, in situ and in vivo methods. Generic biologics (biosimilar drug products), clinical significance of bioequivalence studies, special concerns in bioavailability and bioequivalence studies, generic substitution.
Unit 5: Application of Pharmacokinetics
Modified-release drug products, targeted drug delivery systems and biotechnological products. Introduction to pharmacokinetics and pharmacodynamics, drug interactions. Pharmacokinetics and pharmacodynamics of biotechnology drugs: introduction, proteins and peptides, monoclonal antibodies, oligonucleotides, vaccines (immunotherapy), gene therapies.
MPH203T Computer Aided Drug Delivery System
Subject notes: MPH203T Computer Aided Drug Delivery System notes
Unit 1: Computers in Pharmaceutical Research and Development: A General Overview; Quality-by-Design
a. Computers in Pharmaceutical Research and Development: A General Overview: History of Computers in Pharmaceutical Research and Development. Statistical modeling in Pharmaceutical research and development: Descriptive versus Mechanistic Modeling, Statistical Parameters, Estimation, Confidence Regions, Nonlinearity at the Optimum, Sensitivity Analysis, Optimal Design, Population Modeling. b. Quality-by-Design in Pharmaceutical Development: Introduction, ICH Q8 guideline, Regulatory and industry views on QbD, Scientifically based QbD: examples of application.
Unit 2: Computational Modeling of Drug Disposition
Introduction, Modeling Techniques: Drug Absorption, Solubility, Intestinal Permeation, Drug Distribution, Drug Excretion, Active Transport; P-gp, BCRP, Nucleoside Transporters, hPEPT1, ASBT, OCT, OATP, BBB-Choline Transporter.
Unit 3: Computer-aided formulation development
Concept of optimization, Optimization parameters, Factorial design, Optimization technology and Screening design. Computers in Pharmaceutical Formulation: Development of pharmaceutical emulsions, microemulsion drug carriers. Legal Protection of Innovative Uses of Computers in R&D, The Ethics of Computing in Pharmaceutical Research, Computers in Market analysis.
Unit 4: Computer-aided biopharmaceutical characterization; Computer Simulations in PK/PD; Computers in Clinical Development
a. Computer-aided biopharmaceutical characterization: Gastrointestinal absorption simulation. Introduction, Theoretical background, Model construction, Parameter sensitivity analysis, Virtual trial, Fed vs. fasted state, In vitro dissolution and in vitro-in vivo correlation, Biowaiver considerations. b. Computer Simulations in Pharmacokinetics and Pharmacodynamics: Introduction, Computer Simulation: Whole Organism, Isolated Tissues, Organs, Cell, Proteins and Genes. c. Computers in Clinical Development: Clinical Data Collection and Management, Regulation of Computer Systems.
Unit 5: Artificial Intelligence (AI), Robotics and Computational fluid dynamics
General overview, Pharmaceutical Automation, Pharmaceutical applications, Advantages and Disadvantages. Current Challenges and Future Directions.
MPH204T Cosmetic and Cosmeceuticals
Subject notes: MPH204T Cosmetic and Cosmeceuticals notes
Unit 1: Cosmetics, Regulatory
Definition of cosmetic products as per Indian regulation. Indian regulatory requirements for labeling of cosmetics. Regulatory provisions relating to import of cosmetics. Misbranded and spurious cosmetics. Regulatory provisions relating to manufacture of cosmetics: conditions for obtaining license, prohibition of manufacture and sale of certain cosmetics, loan license, offences and penalties.
Unit 2: Cosmetics, Biological aspects
Structure of skin relating to problems like dry skin, acne, pigmentation, prickly heat, wrinkles and body odor. Structure of hair and hair growth cycle. Common problems associated with oral cavity. Cleansing and care needs for face, eye lids, lips, hands, feet, nail, scalp, neck, body and under-arm.
Unit 3: Formulation Building blocks
Building blocks for different product formulations of cosmetics/cosmeceuticals. Surfactants: classification and application. Emollients, rheological additives: classification and application. Antimicrobials used as preservatives, their merits and demerits. Factors affecting microbial preservative efficacy. Building blocks for formulation of a moisturizing cream, vanishing cream, cold cream, shampoo and toothpaste. Soaps and syndet bars. Perfumes: classification of perfumes. Perfume ingredients listed as allergens in EU regulation. Controversial ingredients: parabens, formaldehyde liberators, dioxane.
Unit 4: Design of cosmeceutical products
Sun protection, sunscreens classification and regulatory aspects. Addressing dry skin, acne, sun-protection, pigmentation, prickly heat, wrinkles, body odor, dandruff, dental cavities, bleeding gums, mouth odor and sensitive teeth through cosmeceutical formulations.
Unit 5: Herbal Cosmetics
Herbal ingredients used in hair care, skin care and oral care. Review of guidelines for herbal cosmetics by private bodies like COSMOS with respect to preservatives, emollients, foaming agents, emulsifiers and rheology modifiers. Challenges in formulating herbal cosmetics.
Practicals and Seminar
- MPH205P Pharmaceutics Practical II
- Seminar/Assignment
Semester 3 and 4
Semester 3 and Semester 4 are common to all M.Pharm specialisations. They cover Research Methodology and Biostatistics (MRM301T), journal club, discussion and presentation, and research work. The full common structure is given on the M.Pharm Common Semester 3 and 4 Syllabus page.