Design and evaluation of fast dissolving buccal films containing tadalafil

Abstract

The present research deals with formulation of a buccal film forming polymers based fast dissolving formulation of an erectile dysfunction drug, Tadalafil. This can offer higher patient compliance and excellent effectiveness of the drug. Low viscosity grade of hydroxypropyl methylcellulose (HPMC E 5 and HPMC E15) were used as excipient. Due to their excellent film forming property and palatable taste. PEG 400 and Propylene glycol were used as plasticizers. Tween 80 used as solubilizing agent, aspartame and menthol, pineapple flavor used as sweetener and taste masking agent respectively. Higher concentration of HPMC E 15 was resulted in sticky film formation. Concentration of PEG 400 and propylene glycol was optimized during preliminary studies. Formulation containing HPMC E 5 (150 mg), E 15 (100 mg) and PEG 400 and Propylene glycol (20 % w/w) showed optimum performance against all other prepared formulations. The formulation was found to show a significant improvement in terms of the drug release as compared to tablet formulation. Thus, fast dissolving buccal film formulation of Tadalafil was successfully developed.