Design and evaluation of sildenafil citrate fast dissolving film for treatment of erectile dysfunction

Sildenafil citrate is one of the most effective agents for treatment of erectile dysfunction which acts by inhibiting the cGMP-specific phosphodiesterase type 5. Extensive research work is focused on flash release dosage forms and especially fast dissolving films are successful to attract pharma-industry due to ease of preparation and opportunity to extend patent life. Films are widely acceptable in patients too because of quick onset and user friendliness. The aim of present study was to prepare fast dissolving films of sildenafil citrate which provides product differentiation from other marketed products and also quick disintegration of highly bitter drug with satisfactory taste masking 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 tongue without any grittiness that is frequently found during disintegration of orodispersible tablets. The developed formulation will disintegrate within minute and ultimately provides good bioavailability and quick onset. The DSC studies showed that drug had no interaction with polymer or other additives. The IR studies confirmed complete complexation of drug 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. The optimized formulation (batch OT6) containing HPMC E15, propylene glycol, glycerin and Kyron T-134 showed drug dissolution (more than 90% within 10 min) with satisfactory taste masking and other physicomechanical properties that were suitable for mouth dissolving film.