Course

Unit I

Preformulation Studies: Introduction to preformulation, goals and objectives, study of physicochemical characteristics of drug substances.

1. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow properties, solubil- ity profile (pKa, pH, partition coefficient), polymorphism
2. 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.

(10 Hours)

Unit II

Tablets:

1. Introduction, ideal characteristics of tablets, classification of tablets. Excipients, Formulation of tab- lets, granulation methods, compression and processing problems. Equipments and tablet tooling.
2. Tablet coating: Types of coating, coating materials, formulation of coating composition, methods of coating, equipment employed and defects in coating.
3. 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

(10 Hours)

Unit III

Capsules:

1. 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.
2. 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

(08 Hours)

Unit IV

Parenteral Products:

1. 1. Definition, types, advantages and limitations. Preformulation factors and essential requirements, vehicles, additives, importance of isotonicity
   2. Production procedure, production facilities and controls, aseptic processing
   3. Formulation of injections, sterile powders, large volume parenterals and lyophilized products.
   4. 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

(10 Hours)

Unit V

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.

(10 Hours)

‘Industrial Pharmacy I – Theory’ is a course offered in the fifth semester of B. Pharm program at School of Pharmacy, Health Sciences campus, Amrita Vishwa Vidyapeetham.

Course Duration: 45 Hours (3 Hours/ week)

Scope:

Course enables the student to understand and appreciate the influence of pharmaceutical additives and various pharmaceutical dosage forms on the performance of the drug product.

Objectives:

Upon completion of the course the student shall be able to

1. Know the various pharmaceutical dosage forms and their manufacturing techniques.
2. Know various considerations in development of pharmaceutical dosage forms
3. Formulate solid, liquid and semisolid dosage forms and evaluate them for their quality