Preformulation
Studies: Molecular optimization of
APIs (drug substances), crystal morphology and variations, powder flow,
structure modification, drug-excipient compatibility studies, methods of
determination.
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.
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.
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.
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.