GPAT Pharmaceutics Syllabus
1. Pharmacy Profession & Introduction to Pharmaceuticals
Pharmacy as a career, evaluation of Pharmacy, earlier period middle to modern
ages. Definition, importance of pharmaceuticals, areas concerned, scope of
Pharmaceutics, history and development of the profession of Pharmacy and
Pharmaceutical industry in India. A brief review of present Indian Pharma.
Industry in global perspective.
2. Introduction to dosage form
Definition of the drug. New drug and dosage form. The desirable properties of a
dosage form, the need of dosage form. Ideas about the available type of dosage
forms and new drug delivery system.
3. Sources of drug information
Introduction to Pharmacopoeia with reference to IP, BP, USP and International
Pharmacopeia. Study of structure/features (index) general notice and compartment
of monographs of excipients, drug and drug product. Other sources. Textbooks,
journals, internet (drug information system, online database, patient/ consumer
information and non- print material. Classification of information, primary,
secondary and tertiary. Nomenclature of the drug.
4. Allopathic dosage form
Merits/demerits, importance, formulation development – vehicles/excipients with
examples for the dosage form: liquid dosage form: monophasic liquid dosage form.
Aromatic waters, syrup, elixir, linctus, lotion, liniment, glycerites, solutions,
spirits, ENT preparations, mixtures, paints, mouthwash.
5. Crude extract
Infusion, decoction, maceration, percolation, tincture and extract. Methods of
preparations of dry, soft and liquid extract.
6. Allergenic extract
Types of allergens, preparation of extract, testing and standardization of extracts.
7. Biological products
Absorbable and non-absorbable material types, sutures and ligatures, processing,
manufacturing, sterilization, packing, QC tests of materials like catgut and nylon.
8. Pharmaceutical Plant, location, layout
Plant location and layout of an industry. Various factors affecting locational
aspects of chemical and pharmaceutical plants. The layout of plant building and
importance of flow sheet, the difference between scientific process and
technological process, the layout of various departments, equipment, and product
layout v/s process layout.
9. Dosage Form Necessities and Additives
Antioxidants, preservatives, coloring agents, flavoring agents and diluting agents,
emulsifying agents, suspending agents, ointment bases, solvents, and others.
10. Powders
Advantages and limitations as dosage form, manufacturing procedure and
equipment, special care and problems in manufacturing powders, powders of IP,
effervescent granules and salts.
11. Capsules
Hard gelatin capsules, shell formulation and manufacturing, capsule sizes, storage,
filing, cleaning process general formulation contents and evaluation. Soft gelatin
capsules, shell formulation, formulation contents, filing, sealing and storage.
Microencapsulation, advantages, encapsulation materials, methods of
microencapsulation, I.P. formulations
12. Tablets
Types, ideal requirement, classification, granulation methods, general formulation,
compression machines, different types of tooling’s, difficulties in tableting,
troubleshooting aspects, evaluation, sugar coating, compression coating, film
coating, problems in tablet coatings and their troubleshooting aspects. IP
formulations.
13. Parenterals – product requiring sterile packaging
Definition, types advantages and limitations, general formulation, vehicles,
production procedure, production facilities, controls, tests, selected IP injections,
sterile powders, implants, emulsions, suspensions.
14. Suspensions
Formulation of deflocculated and flocculated suspension, manufacturing
procedure, evaluation methods, IP suspensions.
15. Emulsions
Types, emulsifying agents, general formulation, manufacturing procedure,
evaluation methods, IP emulsions.
16. Suppositories
Ideal requirements, bases, manufacturing procedure, evaluation methods, IP
products.
17. Semisolids
Definitions, bases, general formulation, manufacturing procedure, evaluation
methods, IP products.
18. Liquids(solutions, syrups, elixirs, spirits, aromatic water, liquid for external uses)
Definition, types, general formulation, manufacturing procedure, evaluation
methods, IP products.
19. Pharmaceutical Aerosols
Definition, propellants, general formulation, manufacturing and packaging
methods, pharmaceutical applications. Impacts of propellants on the environment.
20. Ophthalmic preparations
Requirement, formulation, methods of preparation, containers, evaluation, IP
products.
21. Preformulations
Consideration of Importance, physical properties, physical forms, particle size,
crystal forms, bulk control, solubility, wetting, flow cohesiveness, compressibility,
organoleptic properties and its effect on final product consideration of Chemical
properties, hydrolysis, oxidation, recemization, polymerization, isomerization,
decarboxylation, enzymatic decomposition, formulation additives, stabilizers,
suspending and dispersing agents dyes, solid excipients etc. and its effect on
quality of finished product.
22. Stability of formulated products
Requirements, drug regulatory aspects, pharmaceutical products stability, shelf life,
overages, containers, closures. Reaction rate and order, acid-base catalysis,
destabilization and accelerated stability testing.
23. Prolonged Action Pharmaceuticals
Benefits, limitations, oral products, terminology, drug elimination rate, types and
construction of implants products, product evaluation, parenteral products,
absorption and evaluation.
24. Novel Drug delivery system
Critical fluid technology, transdermal drug delivery system, controlled drug
delivery system, multiple emulsion, nanoparticles, targeted drug delivery system,
aerosols, inhalation & new products reported etc.
25. GMP and Validation
Introduction to GMP, QC and QA. Concept and need of good manufacturing
practice guidelines. Elements of GMP covering controls of area and processes and
product. Regulations related to GMP. Introduction of the validation process. Types
of validation. The brief methodology of process, equipment and instrument
validation.
26. Packaging Materials
Role and features of Pharmaceutical packing materials. Glass, plastic, rubber,
metal and paper as pharmaceutical packaging material. General quality control of
pharmaceutical packages. Primary, secondary and tertiary packaging materials.
Child resistant and pilfer-proof packaging.
27. Cosmetics
Formulation and preparation of dentifrices, hair creams, lipsticks, face powders,
shaving preparations, skin creams, shampoos, hair dyes, depilatories, manicure
preparations etc.
28. Pilot plant scale-up techniques
Need, organization and layout, scale-up techniques for solid and liquid dosage
forms. Technology transfer.
