Utilization of Physiologically based Biopharmaceutical Modelling and Simulations for Proposed Dissolution Specifications of Acetazolamide ER Capsules 500 mg

Abstract

This study investigates the application of physiologically based biopharmaceutics modeling (PBBM) to propose revised dissolution specifications for Acetazolamide Extended Release (ER) Capsules 500 mg which were different from the currently approved specifications. Acetazolamide is a carbonic anhydrase inhibitor which is utilized in the treatment of glaucoma and epilepsy, where extended-release formulations are designed to ensure sustained therapeutic levels.The research leverages PBBM to simulate gastrointestinal transit, drug release, and absorption dynamics, integrating comprehensive physiological, biochemical, and pharmacokinetic data. The model is meticulously calibrated and validated using existing clinical pharmacokinetic profiles. A range of dissolution profiles is simulated to determine optimal specifications that better align with in vivo performance compared to the approved standards.Results indicate that the proposed revised dissolution specifications demonstrate a closer correlation with in vivo drug release and absorption patterns, suggesting potential improvements in bioavailability and therapeutic efficacy. This study underscores the utility of PBBM in regulatory frameworks, offering a scientifically robust approach to revising dissolution specifications and ensuring enhanced drug quality and patient outcomes.