GATE SYLLABUS FOR PHARMACEUTICAL SCIENCES

GATE SYLLABUS FOR PHARMACEUTICAL SCIENCES - PY

Introduction to Physical pharmacy; Matter, Properties of Matter: State of matter, change in the state of matter, latent heats and vapor pressure, sublimation-critical point, Eutectic mixtures, gases, aerosols-inhalers, relative humidity, liquid. complexes, liquid crystals, glassy state, solids- crystalline, amorphous and polymorphism.

Micromeretics and Powder Rheology: Particle size and distribution, average particle size, number and weight distribution, particle number, methods for determining particle volume, methods of determining particle size- optical microscopy, sieving, sedimentation; measurements of particle shape, specific surface area; methods for determining surface area; permeability, adsorption, derived properties of powders, porosity, packing arrangement, densities, bulkiness & flow properties.

Surface and Interfacial Phenomenon: Liquid interface, surface and interfacial tensions, surface free energy, measurement of surface and interfacial tensions, spreading coefficient, adsorption at liquid interfaces, surface active agents, HLB classification, solubilization, detergency, adsorption at solid interfaces, solid-gas and solid-liquid interfaces, complex films, electrical properties of interface.

Viscosity and Rheology: Newtonian systems, Law of flow, kinematic viscosity, effect of temperature; non-Newtonian systems: pseudoplastic, dilatant, plastic; thixotropy, thixotropy in formulation, negative thixotropy, determination of viscosity, capillary, falling ball, rotational viscometers.

Dispersion Systems: Colloidal dispersions: Definition, types, properties of colloids, protective colloids, applications of colloids in pharmacy; Suspensions and Emulsions: Interfacial properties of suspended particles, settling in suspensions, theory of sedimentation, effect of Brownian motion, sedimentation of flocculated particles, sedimentation parameters, wetting of particles, controlled flocculation, flocculation in structured vehicles, rheological considerations; Emulsions-types, theories, physical stability.

Complexation: Classification of complexes, methods of preparation and analysis, applications.

Kinetics and Drug Stability: General considerations & concepts, half-life determination, Influence of temperature, light, solvent, catalytic species and other factors, Accelerated stability study, expiration dating.

Importance of microbiology in pharmacy; Structure of bacterial cell; Classification of microbes and their taxonomy: Actinomycetes, bacteria, rickettsiae, spirochetes and viruses;

Identification of Microbes: Stains and types of staining techniques, electron microscopy; Nutrition, cultivation, isolation of bacteria, actinomycetes, fungi, viruses, etc; Microbial genetics and variation;

Control of microbes by physical and chemical methods: Disinfection, factors influencing disinfectants, dynamics of disinfection, disinfectants and antiseptics and their evaluation;

Sterilization: different methods, validation of sterilization methods & equipments; Sterility testing of all pharmaceutical products. Microbial assays of antibiotics, vitamins & amino acids.

Immunology and Immunological Preparations: Principles, antigens and heptans, immune system, cellular/humoral immunity, immunological tolerance, antigen-antibody reactions and their applications. Hypersensitivity, active and passive immunization. Vaccines and sera: their preparation, standardization and storage.

Genetic Recombination: Transformation, conjugation, transduction, protoplast fusion and gene cloning and their applications. Development of hybridoma for monoclonal antibodies. Study of drugs produced by biotechnology such as Activase, Humulin, Humatrope, HB etc;

Antibiotics: Historical development of antibiotics. Antimicrobial spectrum and methods used for their standardization. Screening of soil for organisms producing antibiotics, fermenter, its design, control of different parameters. Isolation of mutants, factors influencing rate of mutation. Design of fermentation process. Isolation of fermentation products with special reference to penicillins, streptomycins tetracyclines and vitamin B12.

Introduction to pharmaceutical jurisprudence & ethics : Pharmaceutical Legislations - A brief review; Drugs & Pharmaceutical Industry - A brief review; Pharmaceutical Education - A brief review;

An elaborate study of the followings: Pharmaceutical Ethics; Pharmacy Act 1948; Drugs and Cosmetics Act 1940 and Rules 1945; Medicinal & Toilet Preparations (Excise Duties) Act 1955; Narcotic Drugs & Psychotropic Substances Act 1985 & Rules; Drugs Price Control Order;

A brief study of the following Acts with special reference to the main provisions and the latest amendments: Poisons Act 1919; Drugs and Magic Remedies (Objectionable Advertisements) Act 1954; Medical Termination of Pregnancy Act 1970 & Rules 1975; Prevention of Cruelty to Animals Act 1960; States Shops & Establishments Act & Rules; Insecticides Act 1968; AICTE Act 1987; Factories Act 1948; Minimum Wages Act 1948; Patents Act 1970. A brief study of the various Prescription/Non-prescription Products. Medical/Surgical accessories, diagnostic aids, appliances available in the market.

Introduction to dispensing and community pharmacy; Prescription: Handling of prescription, source of errors in prescription, care required in dispensing procedures including labeling of dispensed products. General dispensing procedures including labeling of dispensed products; Pharmaceutical calculations: Posology, calculation of doses for infants, adults and elderly patients; Enlarging and reducing recipes percentage solutions, alligation, alcohol dilution, proof spirit, isotonic solutions, displacement value etc;

Principles involved and procedures adopted in dispensing of : Typical prescriptions like mixtures, solutions, emulsions, creams, ointments, powders, capsules, pastes, jellies, suppositories, ophthalmic, pastilles, lozenges, pills, lotions, liniments, inhalations, paints sprays tablet triturates, etc;

Incompatibilities: Physical and chemical incompatibilities, inorganic incompatibilities including incompatibilities of metals and their salts, non-metals, acids, alkalis, organic incompatibilities. Purine bases, alkaloids, pyrazolone derivatives, amino acids, quaternary ammonium compounds, carbohydrates, glycosides, anesthetics, dyes, surface active agents, correction of incompatibilities. Therapeutic incompatibilities;

Community Pharmacy: Organization and structure of retail and whole sale drug store-types of drug store and design, legal requirements for establishment, maintenance and drug store-dispensing of proprietary products, maintenance of records of retail and wholesale, patient counseling, role of pharmacist in community health care and education (First aid, communicable diseases, nutrition, family planning).

Organization and Structure of hospital pharmacy: Organization of a hospital and hospital pharmacy, Responsibilities of a hospital pharmacist, Pharmacy and therapeutic committee, Budget preparation and Implementation.

Hospital Formulary: Contents, preparation and revision of hospital formulary.

Drug Store Management and Inventory Control: Organization of drug store, Types of materials stocked, storage conditions; Purchase and Inventory Control principles, purchase procedures, Purchase order, Procurement and stocking;

Drug distribution Systems in Hospitals: Out-patient dispensing, methods adopted; Dispensing of drugs to in-patients. Types of drug distribution systems. Charging policy, labeling; Dispensing of drugs to ambulatory patients; Dispensing of controlled drugs, Dispensing of ancillary supplies;

Central Sterile Supply Unit and their Management: Types of materials for sterilization, Packing of materials prior to sterilization, sterilization equipments, Supply of sterile materials.

Manufacture of Sterile and Non-sterile Products: Policy making of manufacturable items, demand and costing, personnel requirements, manufacturing practice, Master formula Card, production control, Manufacturing records.

Drug Information Services: Sources' of Information on drugs, disease, treatment schedules, procurement of information, Computerized services (e.g., MEDLINE), Retrieval of information, Medication error- types of medication errors, correction and reporting.

Records and Reports: Prescription filling, drug profile, patient medication profile, cases on drug interaction and adverse reactions, idiosyncratic cases. Pharmacoeconomics: Introduction to pharmacoeconomics, different methods of pharmacoeconomics, application of pharmacoeconomics. Pharmacoepidemiology: Definition and scope, method to conduct pharmacoepidemiological studies, advantages & disadvantages of pharmacoepidemiological studies.

Nuclear Pharmacy: Methods of handling radioisotopes, radioisotope committee.

Importance of unit operations in manufacturing; Stoichiometry: Unit processes material and energy balances, molecular units, mole fraction, tie substance, gas laws, mole volume, primary and secondary quantities, equilibrium state, rate process, steady and unsteady states, dimensionless equations, dimensionless formulae, dimensionless groups, different types of graphic representation, mathematical problems.

Fluid Flow: Types of flow, Reynold's number, Viscosity, Concept of boundary layer, basic equations of fluid flow, valves, flow meters, manometers and measurement of flow and pressure.

Heat transfer: Concept of heat flow, applications of Fourier’s law, forced and natural convection, surface coefficients, boiling liquids, condensing vapors, heat exchangers, heat interchangers, radiation, black body, Stefan Boltzmann equation, Kirchoff’s law.

Evaporation: Basic concept of phase equilibria, factor affecting evaporation, evaporators, film evaporators, single effect and multiple effect evaporators, Mathematical problems on evaporation.

Distillation: Roult's law, phase diagrams, volatility; simple steam and flash distillations, principles of rectification, Mc-Cabe Thiele method for calculations of number of theoretical plates, Azeotropic and extractive distillation.

Drying: Moisture content and mechanism of drying, rate of drying and time of drying calculations; classification and types of dryers, dryers used in pharmaceutical industries and special drying methods.

Size Reduction: Definition, objectives of size reduction, mechanisms of size reduction, factors affecting size reduction, laws governing energy and power requirements of a mills including ball mill, hammer mill, fluid energy mill. Size separation: Different techniques of size separation, sieves, sieve shakers, sedimentation tank, cyclone separators, bag fillers etc.

Mixing: Theory of mixing, solid-solid, solid-liquid and liquid-liquid mixing equipments.

Filtration and Centrifugation: Theory of filtration, continuous and batch filters, filter aids, filter media, industrial filters including filter press, rotary filter, edge filter, etc. Factors affecting filtration, filtration, optimum cleaning cycle in batch filters. Principles of centrifugation, industrial centrifugal filters, and centrifugal sedimenters;

Crystallization: Characteristics of crystals like-purity, size, shape, geometry, habit, forms size and factors affecting them, Solubility curves and calculation of yields. Material and heat balances around Swenson Walker Crystallizer. Supersaturation, theory and its limitations, Nucleation mechanisms, crystal growth. Study of various types of Crystallizers, tanks, agitated batch, Swenson Walker, Single vacuum, circulating magma and Krystal Crystallizer, Caking of crystals and its prevention. Numerical problems on yields;

Dehumidification and Humidity Control: Basic concepts and definition, wet bulb and adiabatic saturation temperatures, Hygrometric chart and measurement of humidity, application of humidity measurement in pharmacy, equipments for dehumidificat4ion operations;

Refrigeration and Air Conditioning: Principle and applications of refrigeration and air conditioning;

Material of Construction : General study of composition, corrosion, resistance, Properties and applications of the materials of construction with special reference to stainless steel and glass.

Material Handling Systems: Liquid handling - Different types of pumps, Gas handling-Various types of fans, blowers and compressors, Solid handling-Bins, Bunkers, Conveyers, Air transport.

Corrosion: Classification, mechanism of corrosion, factors affecting, prevention and control.

Plant location: Layout, utilities and services.

Industrial Hazards and Safety Precautions: Mechanical, Chemical, Electrical, fire and dust hazards. Industrial dermatitis, Accident records etc.

Automated Process Control Systems: Process variables, temperature, pressure, flow, level and vacuum and their measurements; elements of automatic process control and introduction to automatic process control systems; elements of computer aided manufacturing (CAM). Reactors and fundamentals of reactors design for chemical reactions.

Liquid Dosages Forms: Introduction, types of additives used in formulations, vehicles, stabilizers, preservatives, suspending agents, emulsifying agents, solubilizers, colors, flavors and others, manufacturing packaging, labeling, evaluation of clear liquids, suspensions and emulsions official in pharmacopoeia;

Semisolid Dosage Forms: Definitions, types, mechanisms of drug penetration, factors influencing penetration, semisolid bases and their selection. General formulation of semisolids, clear gels manufacturing procedure, evaluation and packaging;

Suppositories: Ideal requirements, bases, displacement value, manufacturing procedure, packaging and evaluation;

Extraction and Galenical Products: Principle and method of extraction, preparation of infusion, tinctures, dry and soft liquid extracts;

Blood Products and Plasma Substitutes: Collection, processing and storage of whole human blood, concentrated human RBCs, dried human plasma, human fibrinogen, human thrombin, human normal immunoglobulin, human fibrin, foam plasma substitutes, -ideal requirements, PVP, dextran etc. for control of blood pressure as per I.P.;

Pharmaceutical Aerosols: Definition, propellants, general formulation, manufacturing' and packaging methods, pharmaceutical applications;

Ophthalmic Preparations: Requirements, formulation, methods of preparation, labeling, containers, evaluation;

Cosmeticology and Cosmetic Preparations: Fundamentals of cosmetic science, structure and functions of skin and hair. Formulation, preparation and packaging of cosmetics for skin, hair, dentifrice and manicure preparations like nail polish, nail polish remover, Lipsticks, eye lashes, baby care products etc.

Capsules: Advantages and disadvantages of capsule dosage form, material for production of hard gelatin capsules, size of capsules, formulation, method of capsule filling, soft gelatin, capsule shell and capsule content, importance of base absorption and minimum/gm factors in soft capsules, quality control, stability testing and storage of capsule dosage forms.

Micro-encapsulation: Types of microcapsules, importance of microencapsulation in pharmacy, microencapsulation by phase separation, coacervation, multi-orifice, spray drying, spray congealing, polymerization complex emulsion, air suspension technique, coating pan and other techniques, evaluation of micro capsules.

Tablets: Advantages and disadvantages of tablets, Application of different types of tablets, Formulation of different types of tablets, granulation, technology on large-scale by various techniques, different types of tablet compression machinery and the equipments employed, evaluation of tablets. Coating of Tablets: Types of coating, film forming materials, formulation of coating solution, equipments for coating, coating process, evaluation of coated tablets. Stability kinetics and quality assurance.

Parenteral Products: Pre-formulation factors, routes of administration, water for injection, and sterile water for injection, pyrogenicity, non aqueous vehicles, isotonicity and methods of its adjustment, Formulation details, Containers and closures and selection, labeling; Pre-filling treatment, washing of containers and closures, preparation of solution and suspensions, filling and closing of ampoules, vials, infusion fluids, lyophilization & preparation of sterile powders, equipment for large scale manufacture and evaluation of parenteral products; Aseptic Techniques-source of contamination and methods of prevention, Design of aseptic area, Laminar flow bench services and maintenance. Sterility testing of pharmaceuticals.

Surgical products: Definition, primary wound dressing, absorbents, surgical cotton, surgical gauzes etc., bandages, adhesive tape, protective cellulosic hemostastics, official dressings, absorbable and non-absorbable sutures, ligatures and catguts.

Packaging of Pharmaceutical Products: Packaging components, types, specifications and methods of evaluation, stability aspects of packaging. Packaging equipments, factors influence choice of containers, legal and official requirements for containers, package testing.

Designing of dosage forms; Pre-formulation studies: Study of physical properties of drug like physical form, particle size, shape, density, wetting, dielectric constant. Solubility, dissolution and organoleptic properties and their effect on formulation, stability and bioavailability. Study of chemical properties of drugs like hydrolysis, oxidation, reduction, racemization, polymerization etc., and their influence on formulation and stability of products. Study of pro-drugs in solving problems related to stability, bioavailability and elegancy of formulations. Design, development and process validation methods for pharmaceutical operations involved in the production of pharmaceutical products with special reference to tablets, suspensions. Stabilization and stability testing protocol for various pharmaceutical products. ICH Guidelines for stability testing of formulations.

Performance evaluation methods: In-vitro dissolution studies for solid dosage forms methods, interpretation of dissolution data. Bioavailability studies and bioavailability testing protocol and procedures. In vivo methods of evaluation and statistical treatment. GMP and quality assurance, Quality audit. Design, development, production and evaluation of controlled/sustained/extended release formulations.

Biopharmaceutics: Passage of drugs across biological barrier (passive diffusion, active transport, facilitated diffusion, ion-pair formation and pinocytosis); Factors influencing absorption- biological, physico-chemical, physiological and pharmaceutical; Drug distribution in the body, plasma protein binding.

Pharmacokinetics: Significance of plasma drug concentration measurement. Compartment model- Definition and Scope. Pharmacokinetics of drug absorption - Zero order and first order absorption rate constant using Wagner-Nelson and residual methods. Volume of distribution and distribution coefficient. Compartment kinetics- One compartment and two compartment models. Determination of pharmacokinetic parameters from plasma and urine data after drug administration by intravascular and oral route. Clearance concept, mechanism of renal clearance, clearance ratio, determination of renal clearance. Extraction ratio, hepatic clearance, biliary excretion, extra-hepatic circulation. Non-linear pharmacokinetics with special reference to one compartment model after I.V. drug administration.

Clinical Pharmacokinetics: Definition and scope: Dosage adjustment in patients with and without renal and hepatic failure; Design of single dose bio-equivalence study and relevant statistics; Pharmacokinetic drug interactions and their significance in combination therapy.

Bioavailability and bioequivalence: Measures of bioavailability, Cmax, tmax, Keli and Area Under the Curve (AUC); Design of single dose bioequivalence study and relevant statistics; Review of regulatory requirements for conducting bioequivalent studies. Biopharmaceutical Classification System (BCS) of drugs.