Formulation and Characterization of Rapidly Dissolving Films of Cetirizine hydrochloride using Pullulan as a Film Forming Agent

摘要

Rapidly dissolving films have been introduced in the market recently as they provide convenience and ease of use over other dosage forms such as orally disintegrating tablets. In the present study, rapidly dissolving films of cetirizine hydrochloride were formulated using pullulan as film forming polymer. Pullulan is a water soluble polysaccharide produced from yeast Aureobasidium pullulans. Cetirizine hydrochloride, an anti-histamine drug was selected for the study. Solvent casting was the method used for formation of rapidly dissolving films. The rapidly dissolving films were evaluated for the effect of type of casting surface and plasticizer on film separation and taste masking properties. Type of casting surface played a critical role in film formation and separation. Percentage and type of plasticizer affected the formation of rapidly dissolving film. Cetirizine hydrochloride being slightly bitter, taste masking was achieved by use of sweeteners, flavours and citric acid. Type of flavour significantly affected the taste masking property. The in vitro and in vivo disintegration time of the optimized batch PA3 was found to be 30 seconds and 20 seconds respectively. The films exhibited satisfactory thickness, mechanical properties like tensile strength, % elongation and elastic modulus. In vitro dissolution studies, in vivo disintegration studies and surface morphology using environment scanning electron microscopy were also performed. Surface morphology study suggested even distribution of cetirizine hydrochloride in the film and uniformity of the film. The optimized batch was found to be stable for six months under specified stability conditions.