Abstract

ASENAPINE MALEATE MOUTH DISSOLVING FILM: A BREAKTHROUGH TREATMENT IN SCHIZOPHRENIA

Rakesh M. Bachhav, Chandrakant R. Kokare and Umesh D. Laddha*

ABSTRACT

Asenapine maleate is a newfangled drug approved by the FDA for treatment of schizophrenia. Conventionally it is available in oral solid dosage forms, which possess lower bioavailability. Fast dissolving drug delivery system is meant to avert problems associated with accustomed approach. This delivery system undergoes expeditiously disintegration without administration of water and drug get access into systemic circulation via lamina propria. A novel mouth dissolving film of asenapine maleate was prepared by using Hydroxy Propyl Methyl Celluloses E-5 LV by solvent casting method. Qbd-32 factorial design was used to study the effect of independent variables concentration of HPMC and PG on dependent variables viz. % cumulative drug release after 10 min, folding endurance and disintegration time. Films were subjected to in vitro drug release studies which showed 85.36–98.31% drug release within 10 min. Ex vivo studies of optimized formulation showed 86% drug permeation through oral sheep mucosa within 15 min and no cell necrosis was observed during histological study. The stability of optimized batch was found to be stable for six months under specified stability conditions. In conclusion, asenapine maleate mouth dissolving film considers as successful therapeutic alternative to conventional formulation.

Keywords: Asenapine Maleate, Mouth dissolving film, optimization, Ex-vivo.