Design and Evaluation of Fast Dissolving Film Formulation for Erectile Dysfunction

Abstract

Aim: The aim of present study was to prepare fast dissolving films of Sildenafil citrate and Tadalafil which provide product differentiation from other marketed products, quick disintegration and faster dissolution with satisfactory taste in oral cavity. Film formulation can be taken within the pocket and patient can take it without need of water by simply putting it on the tongue without any grittiness that is frequently found during the disintegration of orodispersible tablets. The developed formulation will disintegrate within a minute and ultimately provides good bioavailability and quick onset. Materials and Methods: The films were prepared by solvent casting method using hypromellose as film former. The DSC studies showed that drug had no interaction with polymer or other additives. The IR studies confirmed complete complexation of Sildenafil citrate with taste masking resin. Using experimental design, the prepared formulations were evaluated for in vitro dissolution, solution time and their physicomechanical parameters mainly tensile strength. Results and Discussion: The optimized Sildenafil citrate film (batch OT6) containing HPMC E15, propylene glycol, glycerin and Kyron T-134 showed better drug dissolution (more than 90% within 10 min) with satisfactory taste masking and other physicomechanical properties. The optimized Tadalafil film (batch FT9) containing HPMC E6, propylene glycol and poloxamer 407 showed greater drug dissolution, satisfactory in vitro disintegration time (20.07 s) and other physicomechanical properties. Conclusion: From the results, Kyron T-134 was considered better taste masking agent for Sildenafil citrate and poloxamer 407 was considered better solubility enhancer for Tadalafil. The development of fast dissolving film for erectile dysfunction is one of the alternative routes to provide quick onset of action.