3 Review(s)

Preformulation studies encompass a range of crucial investigations, including molecular optimization of APIs, analysis of crystal morphology, and assessment of powder flow. These studies delve into structure modification and evaluate drug-excipient compatibility to lay the groundwork for successful formulation development. Methods of determination are meticulously employed to understand the physicochemical properties of drug substances. In parallel, formulation additives are scrutinized, considering factors influencing their incorporation and the evolving landscape of excipient science. This involves leveraging design of experiments like factorial design for comprehensive product and process development. Solubility studies play a pivotal role, with emphasis on experimental determination and techniques such as cosolvency and solid dispersion to enhance drug solubility. Dissolution theories and mechanisms, along with in-vitro dissolution testing models, are explored to elucidate factors influencing dissolution and establish in-vitro and in-vivo correlations. Product stability studies encompass degradation kinetics, stability testing, and interpretation of kinetic data, adhering to stringent protocols and ICH guidelines to ensure pharmaceutical quality and safety.