Introduction to preformulation, goals and objectives, study of physicochemical characteristics of drug substances. a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow properties, solubility profile (pKa, pH, partition coefficient), polymorphism

b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization BCS classification of drugs & its significant Application of preformulation considerations in the development of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms

a. Introduction, ideal characteristics of tablets, classification of tablets. Excipients, Formulation of tablets, granulation methods, compression and processing problems. Equipments and tablet tooling

Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. size of capsules, Filling, finishing and special techniques of formulation of hard gelatin capsules, manufacturing defects. In process and final product quality control tests for capsules.

a. Definition, types, advantages and limitations. Preformulation factors and essential requirements, vehicles, additives, importance of isotonicity b. Production procedure, production facilities and controls, aseptic processing