Virtual Bioequivalence Assessment and Dissolution Safe Space Exploration for Fixed-Dose Metformin-Glyburide Tablet Using Physiologically Based Biopharmaceutics Modeling.

ABSTRACT: Background/Objectives: Fixed-dose combinations (FDCs) hold significant clinical value for the management of hypertension, diabetes and other chronic diseases. However, since the complexity of formulations, generic compounds require both in vitro pharmaceutical equivalence and in vivo bioequivalence (BE) for each active pharmaceutical ingredient (API). Physiologically based biopharmaceutics modeling (PBBM) not only bridges in vitro drug properties to in vivo pharmacokinetics but effectively assesses the impact of formulations on systemic exposure. This study was aimed at developing a PBBM for metformin-glyburide FDC and investigating its clinically relevant quality specifications. Methods: PK-Sim^® software (Version 11.3) was used to establish a PBBM for a metformin-

SUBMITTER: Zhao C 

PROVIDER: S-EPMC12566952 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature