Formulation and Optimization of Mucoadhesive Buccal Film for Nicotine Replacement Therapy

Abstract

Objective: Nicotine replacement therapy (NRT) is a widely used method for reducing the desire to smoke and managing withdrawal symptoms during smoking cessation efforts. The research work aims to prepare and optimize a mucoadhesive nicotine buccal film by solvent casting method to provide the rapid onset and prolonged effects of cigarette smoking. Methods: Mucoadhesive nicotine buccal films were developed from the polymers Carbopol 934, Eudragit RLPO, and HPMC E15 by solvent casting method. The optimization of the mucoadhesive nicotine buccal film was performed using a three-factor, three-level Box-Behnken design where Carbopol 934, Eudragit RLPO, and HPMC E15 were selected as independent variables, while the swelling index, adhesion time, mucoadhesive strength, and cumulative % drug release were selected as response variables. Results: The optimized mucoadhesive nicotine buccal film showed uniform thickness and drug content. It had a swelling index of 188.21%, adhesion time of 7 h 45 min, and mucoadhesive strength of 0.23 N. The film showed a burst release followed by a steady release of 76.55 % over 360 min. It exhibited a 2-fold enhancement in buccal mucosal permeation as compared to a lozenge. Conclusion: The mucoadhesive nicotine buccal film prepared by the solvent casting method provides a rapid onset of action and prolonged effect for an extended period which replicates the effects of cigarette smoking. The findings show that it will reduce the frequency of administration, as a result of decreased nicotine cravings and reduced withdrawal symptoms, compared to currently available NRTs, ultimately helping individuals quit smoking.