DESIGN AND CHARACTERIZATION OF SOLID DISPERSED FEXOFENADINE HYDROCHLORIDE BUCCAL FILM BY CENTRAL COMPOSITE DESIGN

摘要

Fexofenadine Hydrochloride (FHCl) is a second generation antihistaminic drug which is used in the treatment of allergic rhinitis and urticaria. It is a BCS class II drug and has high first pass metabolism leading to low oral bioavailability. Drug-inclusion complex with 2HPβCD was prepared by kneading method and characterized for solubility study, FTIR study and in vitro dissolution study. Nine different combinations of polymers to be added were generated by Central Composite Design was used to evaluate dependent parameters by varying the independent variables, HPMC E5 and HPMC K4M and responses were tensile strength, mucoadhesive strength and in vitro diffusion. Films were prepared and evaluated for different parameters and found to be in acceptable limits. Optimized formulation F10 generated from the design showed good tensile strength and mucoadhesive strength and optimum in vitro diffusion results. Drug permeation through porcine oral mucosa at the end of 120 mins was 85.59%. Short term stability studies revealed that formulation was stable after storage for 1 month.