Abstract
Sildenafil citrate is an oral therapy for erectile dysfunction (ED). Sildenafil, a selective inhibitor of cyclic guanosine monophosphate-specific phosphodiesterase type 5 (PDE5), has been reported to be effective in men with ED associated with diabetes and prostate cancer, and in psychogenic ED. The main objective of this study is to prepare more effective, rapidly disintegrating and rapid onset of action sildenafil oral tablets. Sildenafil tablets were prepared using the newly introduced Pharmaburst® as a direct compression vehicle in comparison with the well-known excipients, namely mannitol, anhydrous lactose and primojel. The formula containing Pharmaburst® showed the most rapidly-disintegrating effect (15 sec) compared to the other formulations. Thus, Pharmaburst® can be utilized as an effective direct compression vehicle as well as a superdisintegrant with very rapid disintegration time in vitro and in the oral cavity. The rapidly-disintegrating sildenafil tablets showed maximum serum concentration within only two minutes (Cmax of 0.76 µg) by applying the tablets to the oral cavity of rabbits, whereas, the conventional sildenafil tablets have a comparatively lower Cmax (0.56µg) through about 45 minutes. 
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