Patent ID: 6552024
Filing Date: 2003-04-22
Classification: A61K,A61P

Abstract:
A dosage unit, comprising: an effective dose of sildenafil citrate; the sildenafil citrate being formed in a solid dispersion with a water soluble inert filler, the solid dispersion being mixed with film forming reagents including a hydropolymer so as to form a film, the film being capable of dissolving on a mucosal surface so as to release the sildenafil citrate; wherein the film exhibits a dry tack value of less than 3.5 g, a wet tack of greater than 35 g, a gelation temperature that is greater than 70Â° C. for a 2% polymer solution, a dry film thickness of not more than 20 mil, a water content of 0.5 to 10%, a tensile strength greater than 1500 psi, a modulus in the range of 35,000 to 300,000 psi, a % elongation of less than 20%, a tear propagation resistance of 0.001 to 1 N, and a dissolution time of not more than 600 seconds upon application to an oral mucosal surface.