UNIT – I
Preformulation Studies: Molecular optimization of APIs (drug substances), crystal morphology and variations, powder flow, structure modification, drug-excipient compatibility studies, methods of determination.
UNIT – II
Formulation Additives: Study of different formulation additivies, factors influencing their incorporation, role of formulation development and processing, new developments in excipient science, determination methods, drug excipient interactions. Design of experiments – factorial design for product and process development.
UNIT – III
Solubility: Importance, experimental determination, phase-solubility analysis, pH-solubility profile, solubility techniques to improve solubility and utilization of analytical methods – cosolvency, salt formation, complexation, solid dispersion, micellar solubilization and hydrotropy.
UNIT – IV
Dissolution: Theories, mechanisms of dissolution, in-vitro dissolution testing models – sink and non-sink. Factors influencing dissolution and intrinsic dissolution studies. Dissolution test apparatus – designs, dissolution testing for conventional and controlled release products. Data handling and correction factor. Biorelevent media, in-vitro and in-vivo correlations, levels of correlations.
UNIT – V
Product Stability: Degradation kinetics, mechanisms, stability testing of drugs and pharmaceuticals, factors influencing-media effects and pH effects, accelerated stability studies, interpretation of kinetic data (API & tablets). Solid state stability and shelf life assignment. Stability protocols, reports and ICH guidelines.
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