DoE- and PBBM-Driven Formulation Development of an Extended-Release Donepezil Tablet.

ABSTRACT: Background/Objectives: This study explores the integration of Design of Experiments (DoE) with Physiologically Based Biopharmaceutics Modeling (PBBM) to streamline the development of extended-release (XR) formulations. Using donepezil (DPZ) as a model drug, we developed an optimized XR formulation exhibiting a dissolution profile comparable to the reference product, Aricept^® (Eisai GmbH, Frankfurt, Germany). Methods: A Box-Behnken experimental design was applied to systematically evaluate how formulation variables-HPMC 100, HPMC 4000, and NaCMC-affect drug release kinetics, tablet hydration, and erosion. This strategy enabled the identification of optimal excipient concentrations with minimal experimental effort. Results: The in vitro dissolution data

SUBMITTER: Martins FS 

PROVIDER: S-EPMC12735571 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature