The objective of the present investigation was to formulate, evaluate and optimize oral film of Fexofenadine HCl using (Box Behnken) design. In the present investigation an attempt was made to develop mouth dissolving films of Fexofenadine HCl to achieve fast disintegration and dissolution characteristics with improved bioavailability by oral route. Oral films of Fexofenadine HCl were formulated using HPMC E15 premium polymer as a film forming agent propylene glycol as plasticizer and tween 40 as surfactant. Oral dissolving film was prepared by solvent casting method and was optimized by using box Behnken design (A three factor, three levels). Formulations were prepared using three independent variables namely polymer quantity(X1), Plasticizer(X2) and surfactant concentration(X3), whereas disintegration time (Y1) and % drug release (Y2) as dependent variables. The stability studies of the films were performed for optimized batch as per ICH guideline. From the results of design batches, best batch was selected and evaluated for in vivo pharmacokinetic study in Albino rat model. The drug & excipients were characterized as per IP 2014 Drug and excipients studies using FT-IR. Box Behnken Design using Design Expert Software was used to optimize and evaluate the main effects, interaction effects and quadratic effects of the formulation ingredients on the disintegration time & in vitro drug release. Films were subjected to physicochemical characterization such as thickness, weight variation, appearance, content uniformity, folding endurance, surface pH, in-vitro drug release, the designs establish the role of the derived polynomial equation and contour plots in predicting the values of dependent variables for the preparation and optimization.The optimized batch is passed the accelerated stability studies, no significant change in the dissolution profile. The statistically optimized formulation was characterized with FT-IR (Fourier transform-infrared spectroscopy) studies and found no chemical interactions between drug and polymer.Thus the prepared fast dissolving films of fexofendine HCl could be a better alternative for tablet and capsules an achieving rapid oral bioavailability in treatment of allergic rhinitis.

Keywords: Oral Film Fexofendine [HCl] Was Formulate, Box Behnken Design, Solvent casting technique