Preparation and evaluation of gastroretentive floating unfolding film of baclofen

Abstract

Baclofen, a muscle relaxant used for severe pain management, has a narrow absorption window limiting its bioavailability. Enhancing its gastric residence time could potentially improve its absorption and effectiveness. Floating drug delivery systems are a promising approach to prolong drug retention in the stomach. This study aimed to develop a floating bilayer film for the sustained release of baclofen. The core of the film was formulated with baclofen, PVP K90, sodium alginate, and PEG 400 as a plasticizer, while the controlled release layer contained Eudragit RS100 or RLPO with different plasticizers (DBP and PEG 400). All formulations were evaluated for weight uniformity, drug content, thickness, folding ability, swelling, and in vitro drug release. The optimized formula had a 98% drug release within 12 hours, floated effectively for 24 hours, and followed zero-order kinetics.