Abstract

FORMULATION AND EVALUATION OF ORODISPERSIBLE FILM OF ANTIHISTAMINIC DRUG DIPHENHYDRAMINE HCl

Preeti Tomar*, Sanjiv Kumar Gupta and Neeraj Gautam

ABSTRACT

The aim of this study was to develop a fast releasing oral polymeric thin film, prepared by solvent casting method, with good mechanical properties, instant disintegration and dissolution. Diphenhydramine hydrochloride, an antihistamine drug belonging to BCS class I was used for oral thin film preparation. The formulations from the preliminary trial were analyzed which was applied to optimize the type of polymers (Gelatin and HPMC E15), concentration of polymers, plasticizer (Glycerol, Propylene Glycol, PEG 400), surfactant (TWEEN 80) and sweetener (Mannitol). The resultant films were evaluated for thickness, folding endurance, drug content, Surface pH, in vitro disintegration time, in vitro dissolution studies etc. Oral thin films which were prepared with surfactant showed better results i.e., good disintegrating and dissolution properties than without surfactant. The optimized film disintegrated in less than 30s, releasing more than 90% of drug within 90sec.

Keywords: Diphenhydramine hydrochloride, Orodispersible film, pH, folding endurance etc.