The AudioCast discusses the key considerations for developing modified-release versions of immediate-release oral solid dosage forms. It covers the selection of release mechanisms, establishment of release profiles, understanding of regulatory requirements, formulation and manufacturing considerations, analytical testing methodologies, BCS classification and biowaiver, clinical development planning, and intellectual property protection. Additionally, it emphasizes the benefits of API characterization and pre-formulation work in terms of improving understanding of API properties, identifying formulation challenges, supporting regulatory submissions, and predicting product performance in the body. Lastly, it mentions the essential CMC development data required by health authorities for evaluating submissions, including formulation development, manufacturing processes, analytical method development and validation, stability data, in-vitro release studies, biopharmaceutical classification system and biowaiver, clinical development plans and data, and comparative data.
When developing modified-release oral solid dosage forms, important considerations include selecting the appropriate release mechanism, establishing the optimal release profile, understanding regulatory requirements, addressing CMC considerations related to formulation, manufacturing, and testing, considering BCS classification and biowaiver, developing a clinical development plan, and protecting intellectual property. API characterization and pre-formulation work provide benefits such as improved understanding of API properties, identification of formulation challenges, support for regulatory submissions, enhanced process understanding, better manufacturing control, and improved prediction of product performance in the human body. Health authorities expect to see key CMC development data, including formulation details, manufacturing processes, analytical method development and validation, stability information, in-vitro release studies, BCS classification and biowaiver status, clinical development plan and data, and comparative data. These data are necessary to demonstrate the suitability and quality of the modified release product for regulatory approval.