Class: 3 Hours/ week
Unit I (10 Hours)
Preformulation Studies: Introduction to preformulation, goals and objectives, study of physicochemical characteristics of drug substances.
- Physical properties: Physical form (crystal & amorphous), particle size, shape, flow properties, solubil- ity profile (pKa, pH, partition coefficient), polymorphism
- Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization BCS classifica- tion of drugs & its significant
Application of preformulation considerations in the development of solid, liquid oral and parenteral dos- age forms and its impact on stability of dosage forms.
Unit II (10 Hours)
- Introduction, ideal characteristics of tablets, classification of tablets. Excipients, Formulation of tab- lets, granulation methods, compression and processing problems. Equipments and tablet tooling.
- Tablet coating: Types of coating, coating materials, formulation of coating composition, methods of coating, equipment employed and defects in coating.
- Quality control tests: In process and finished product tests
Liquid orals: Formulation and manufacturing consideration of syrups and elixirs suspensions and emul- sions; Filling and packaging; evaluation of liquid orals official in pharmacopoeia
Unit III (08 Hours)
- Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. size of capsules, Fill- ing, finishing and special techniques of formulation of hard gelatin capsules, manufacturing defects. In process and final product quality control tests for capsules.
- Soft gelatin capsules: Nature of shell and capsule content, size of capsules,importance of base adsorp- tion and minim/gram factors, production, in process and final product quality control tests. Packing, storage and stability testing of soft gelatin capsules and their applications..
Pellets: Introduction, formulation requirements, pelletization process, equipments for manufacture of pellets
Unit IV (10 Hours)
- Definition, types, advantages and limitations. Preformulation factors and essential requirements, vehicles, additives, importance of isotonicity
- Production procedure, production facilities and controls, aseptic processing
- Formulation of injections, sterile powders, large volume parenterals and lyophilized products.
- Containers and closures selection, filling and sealing of ampoules, vials and infusion fluids. Quality control tests of parenteral products.
Ophthalmic Preparations: Introduction, formulation considerations; formulation of eye drops, eye oint- ments and eye lotions; methods of preparation; labeling, containers; evaluation of ophthalmic preparations
Unit V (10 Hours)
Cosmetics: Formulation and preparation of the following cosmetic preparations: lipsticks, shampoos, cold cream and vanishing cream, tooth pastes, hair dyes and sunscreens.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formula- tion and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies.
Packaging Materials Science: Materials used for packaging of pharmaceutical products, factors influ- encing choice of containers, legal and official requirements for containers, stability aspects of packaging materials, quality control tests.