Formulation and Evaluation of Flupirtine Malate Sustained Release Bilayer Tablet

Abstract

The study aimed to formulate and evaluate colon-targeted Flupirtine Maleate tablets using HPMC K100M and HPMC K4M. FT-IR analysis confirmed no drug-polymer interactions, and pre-compression studies indicated good powder flow properties. Tablets were prepared by direct compression and evaluated for various physicochemical parameters. In-vitro dissolution studies showed minimal drug release in acidic and small intestinal environments, with complete release in colonic conditions. The optimized formulation (F4) followed a first-order diffusion-controlled Peppas release mechanism and remained stable over three months. The bilayer tablet approach effectively sustained drug release, enhancing patient compliance and pain management. The study concluded that the bilayer tablet approach effectively sustained the release of Flupirtine Maleate, improving patient compliance and enhancing pain management. The combination of HPMC K100M and HPMC K4M as rate-controlling polymers in the sustained release layer demonstrated promising results, making this formulation a viable option for controlled drug delivery.