Abstract

FORMULATION AND EVALUATION OF FAST DISSOLVING ORAL FILMS CONTAINING BENIDIPINE HYDROCHLORIDE

Pallavi Chalawadi and Kopparam Manjunath*

Abstract

The aim of this study was to formulate & evaluate fast dissolving oral films (FDOF’s) containing benidipine hydrochloride (BEN), a calcium channel blocker used in the treatment of hypertension & angina pectoris. FDOF’s offer several advantages over traditional dosage forms such as improved patient compliance, rapid onset of action & ease of administration without need of water. BEN was incorporated into the films using different polymers, such as HPMC E15, PVP-K30 & PVA to optimize the film properties and drug release profile. The films were prepared by solvent casting method & evaluated for various physicochemical properties, including thickness, weight variation, folding endurance, drug content uniformity & the in-vitro drug release. Among the 9 formulations, F3 formulation shows a rapid drug release 99.91% within 8 minutes. & it has drug content uniformity of 101.76%. The stability studies of the F3 formulation was also assessed under accelerated conditions ensuring their potential long-term storage. The results indicate the fast dissolving oral films of BEN offer an efficient patient friendly alternative to conventional oral dosage forms with potential for improved therapeutic outcomes in the management of hypertension.

Keywords: Fast dissolving oral films, Hypertension, Benidipine hydrochloride.