Formulation development of oral disintegrating film of fexofenadine hydrochloride

Abstract

The present study aimed to develop an oral disintegrating film of fexofenadine hy-drochloride for the immediate management of allergies and related symptoms. The formulation of fast dissolving oral film was carried out by solvent casting method using two different grades of hydroxy propyl methyl cellulose, polyvinyl pyrro-lidone, polyvinyl acetate, and pullulan as polymers and different plasticizers. Six such films were produced. The films were evaluated for their physicochemical and mechanical properties. Compatibility and thermal studies were carried out. The surface morphology of the films was studied. All six formulations were evaluated for surface pH, disintegration, and drug release study in simulated saliva. The best films were taken for stability studies. Formulations prepared with all the polymers in different proportions of plasticizers could produce a non-sticky stable film. The thermal studies revealed the uniform dispersion of the drug in the polymer matrix. Films prepared with pullulan showed better flexibility and dissolution behavior. Stability studies of the pullulan films highlighted that the films were stable and could retain their physical and mechanical properties. Hence, it can be concluded that pullulan can be successfully employed to prepare fast dissolving oral films of fexofenadine hydrochloride.