Abstract

DEVELOPMENT OF CONTROLLED RELEASE BUCCAL FILMS OF VERAPAMIL HYDROCHLORIDE: A SOLVENT CASTING APPROACH

Parthiban S., Yashaswini N. R.*

Abstract

Objective: The study aimed to develop and evaluate mucoadhesive buccal films of Verapamil Hydrochloride, a calcium channel blocker used for hypertension, angina pectoris, and cardiac arrhythmias. The objective was to enhance bioavailability by bypassing first-pass metabolism and to achieve a controlled release drug delivery system for effective management of cardiovascular conditions. Methods: Verapamil Hydrochloride buccal films were prepared using the solvent casting technique with various polymers including Gelzan CM, Sodium Alginate, HPMC E15, and Polyvinyl Alcohol. Preformulation studies including melting point, UV spectroscopy, FTIR, and DSC were conducted to confirm drug identity and compatibility. Films were evaluated for physical parameters such as thickness, weight variation, surface pH, folding endurance, swelling index, moisture uptake/loss, drug content, and in vitro drug release. Drug release kinetics was analyzed using mathematical models. Stability studies were performed under ambient and accelerated conditions to assess long-term performance. Results: Preformulation studies confirmed the identity and compatibility of Verapamil Hydrochloride with the selected polymers. All formulations exhibited acceptable physical and mechanical properties without irritation potential. Drug content was within pharmacopeial limits, and surface pH values were close to physiological buccal pH. In vitro drug release studies demonstrated sustained and controlled release pattern, following non-Fickian (anomalous) diffusion kinetics. Stability studies indicated minimal changes in drug content and release profile, confirming good formulation stability over time. Conclusion: The formulated Verapamil Hydrochloride buccal films showed satisfactory physicochemical characteristics, good stability indicating their potential as an effective controlled-release system for cardiovascular therapy.

Keywords: Buccal Films, Mucoadhesive, Hypertension, Controlled Release, Solvent Casting.