Formulation and In vitro Evaluation of Buccoadhesive Film of Antifungal drug

Abstract

The aim of the present study was to formulate and evaluate in vitro buccoadhesive film of bifonazole. Bifonazole is an antifungal drug. Buccal route offers several advantages such as rapid absorption and higher blood levels due to high vascularization of the region and prolonged duration of action. Hence, in the present work buccoadhesive film of Bifonazole were prepared with the objective of avoiding first pass metabolism and prolonging the duration of action. The main objective of the present study was to increase the buccal retention time for prolonging the release of drug from dosage form which is beneficial in the absorption of drug in buccal cavity. Buccoadhesive film of Bifonazole composed of TSP, Carbopol 934 were prepared by solvent casting method. Optimization of final formulation was carried out by applying 32 full factorial design. Buccoadhesive film were evaluated for swelling index, muccoadhesive strength, muccoadhesive time, drug content uniformity. In vitro drug release study was performed using modified USP dissolution apparatus type II. Optimized batch F5 of buccoadhesive film was selected based on maximum Swelling index, mucoadhesive strength and in vitro drug release study which were taken as critical responses. In vitro dissolution study showed that, the optimized formulation gave maximum amount of dug release 99.41±1.45% in phosphate buffer saline pH 6.8. In vitro permeability study revealed that significantly high permeation of drug was found from buccoadhesive film. Thus, the buccoadhesive film of Bifonazole prepared by solvent casting method showed acceptable mechanical properties and satisfactory in vitro drug release, in vitro permeability, mucooadhesive strength and mucooadhesion time and drug absorption properties. Stability study was performed Study perform at room temperature (30±20C and 65±5% RH) and accelerated condition (40±20C and75±5%RH) over period of one month. The result of stability study indicate there were no change in any parameter of optimize batch F5.