Optimization of Vildagliptin Delivery: Formulation and Evaluation using Box-Behnken Design

The presented study focuses on creating and assessing an in situ gastro-retentive gel designed to deliver Vildagliptin accurately to the stomach. The primary objective is to prolong residence time and enhance drug delivery at the targeted site. The synthesis of these gels in situ utilized a cation-controlled gelation method, incorporating various blends and levels of pectin and HPMCK4M. A thorough evaluation encompassed multiple parameters, including visual appearance, pH values, viscosity, in vitro gel formation, in vitro buoyancy, drug content, density, gel force, water absorption, and in vitro drug release. These gels exhibited a total float time exceeding 12 h, with a float delay time of < 2 min. Formulation T-4, characterized by higher levels of pectin and HPMCK4M demonstrated promising cumulative drug discharges of 96.70±3.28%, over 12h. Subsequent in vitro dissolution and stability studies verified consistent active ingredient content, underscoring the stability of the formulations. In summary, the study underscores the efficacy of the developed in situ gels in prolonging gastric residence time, enabling controlled and sustained discharge of Vildagliptin in the stomach, suggesting potential advancements in drug delivery systems.