Formulation and characterization of nicotine thin films for smoking cessation through buccal delivery

Abstract

Buccal films are the promising technology with fast onset of activity. The current research was intended to prepare buccal thin films of nicotine to augment bioavailability and evade pre-systemic metabolism in smoking cessation, specifically COPD cases. Nicotine thin film was prepared using solvent casting method by using HPMC (E5, E15), PEG with varied compositions. The prepared thin films were cut into strips of area 2X2 cm2 and were evaluated. Weight, thickness and surface pH were increased with decreased concentration of polymer. F5, F6, F7 have shown good folding endurance, this is due to the amalgamation of two grades of HPMC, as PEG was used at 10% concentration, Percentage elongation was constant. Moisture uptake and loss, swelling index were evaluated and variation was overlooked and % transparency was reduced due to dark colouration of extract and reduced further in case of F1 and F3. Accelerated stability studies have not revealed remarkable change in weight, disintegration time and surface pH, which indicates that temperature would not alter the properties of the thin film. From the results of drug release F5 was released 67.08% in 5 min, the total drug release was obtained in a span of 20min and F4 total drug release was obtained in 50 min with the initial release of 33% in 5min. Taking drug release profile into consideration F4 is most suitable formulation as the main objective of the study is to obtain slow release as fast release of nicotine would cause hypotension and inhibition of neurotransmission.