Abstract

“DESIGN, OPTIMIZATION AND EVALUATION OF BUCCAL FILMS OF NICORANDIL USING DESIGN OF EXPERIMENTS”

Thanushree H. N., Kopparam Manjunath*

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Abstract

In this study aim was to formulate & evaluate fast dissolving buccal films (FDBF’s) containing Nicorandil (NIC), a potassium channel activators used in the treatment of angina pectoris & hypertension. fast dissolving buccal films offer several advantages over traditional dosage forms such as improved patient compliance, rapid onset of action & ease of administration without need of water. Nicorandil was incorporated into the films using different polymers, such as HPMC E15 & PVA to optimize the film properties and drug release profile. The films were prepared by solvent casting method. The fast dissolving buccal film of Nicorandil was optimized through a 3- level factorial design and the formulation was optimized on the basis of various evaluation parameters like physicochemical properties, including thickness, weight variation, folding endurance, drug content uniformity & the in-vitro drug release. Among the 13 formulations, F7 formulation shows a rapid drug release 95.3% within 8 minutes. & it has drug content uniformity of 99.26%. The stability studies of the F7 formulation was also assessed under accelerated conditions ensuring their potential long-term storage and the results indicate the fast dissolving buccal films of Nicorandil offer an efficient patient friendly alternative to conventional oral dosage forms with potential for improved therapeutic outcomes in the management of angina pectoris.

Keywords: Fast dissolving buccal films, angina pectoris, Nicorandil.