Formulation and Characterization of Nicotine Buccal Film

The objective of present study was to develop fast dissolving nicotine buccal films for smoking cessation using solvent casting technique. This new formulation (buccal film) was designed particularly for smoking cessation as Nicotine replacement therapy (NRT) to help smokers to quit smoking. The advantages reside on the reduction of side effects of user of tobacco because of its unique characteristic. A response surface methodology experimental design was applied for the optimization of fast dissolving film using Box- Behnken experimental design. Recently various NRT dosage forms including chewing gum, lozenges, mouth spray and transdermal pathches have been developed. However buccal films are preferable over these NRT dosage forms in terms of flexibility and convenience in administration, without showing any outward signs of diseases. Various evaluation parameters like weight variation, thickness, folding endurance, drugcontent, pH determination, disintigration time studies, % moisture loss, mucoadhesive strength, drug excipients interactions studies, in vitro drug release studies, tensile strength and stability studies were performed.