Treatment of erectile dysfunction and other indications

Abstract

The present invention generally relates to the transdermal delivery of various compounds. In some aspects, transdermal delivery may be facilitated by the use of a hostile biophysical environment. One set of embodiments provides a composition for topical delivery comprising a phosphodiesterase type 5 inhibitor and/or a salt thereof, and optionally, a hostile biophysical environment and/or a nitric oxide donor. In some cases, the composition may be stabilized using a combination of a stabilization polymer (such as xanthan gum, KELTROL® BT and/or KELTROL® RD), propylene glycol, and a polysorbate surfactant such as Polysorbate 20, which combination unexpectedly provides temperature stability to the composition, e.g., at elevated temperatures such as at least 40° C. (at least about 104° F.), as compared to compositions lacking one or more of these.

What is claimed is: 
     
         1 - 169 . (canceled) 
     
     
         170 . A transdermal patch for application to the skin of a subject, the transdermal patch comprising a composition comprising:
 an ionic strength of at least about 0.25 M;   a stabilization polymer comprising xanthan gum;   propylene glycol;   a polysorbate surfactant comprising polysorbate 20; and   a phosphodiesterase type 5 inhibitor and/or a salt thereof.   
     
     
         171 . The transdermal patch of  claim 170 , wherein the composition further comprises a nitric oxide donor. 
     
     
         172 . The transdermal patch of  claim 171 , wherein the nitric oxide donor comprises L-arginine and/or an L-arginine salt. 
     
     
         173 . The transdermal patch of  claim 172 , wherein the nitric oxide donor comprises L-arginine. 
     
     
         174 . The transdermal patch of  claim 172 , wherein the nitric oxide donor comprises L-arginine hydrochloride. 
     
     
         175 . The transdermal patch of  claim 171 , wherein the nitric oxide donor is present at at least about 0.5% by weight of the composition. 
     
     
         176 . The transdermal patch of  claim 170 , wherein the composition comprises sodium chloride. 
     
     
         177 . The transdermal patch of  claim 176 , wherein the sodium chloride is present at at least about 5% by weight of the composition. 
     
     
         178 . The transdermal patch of  claim 170 , wherein the composition comprises one or more salts selected from the group consisting of choline chloride, magnesium chloride, lithium chloride, and calcium chloride. 
     
     
         179 . The transdermal patch of  claim 170 , wherein the phosphodiesterase type 5 inhibitor is sildenafil. 
     
     
         180 . The transdermal patch of  claim 170 , wherein the phosphodiesterase type 5 inhibitor is avanafil. 
     
     
         181 . The transdermal patch of  claim 170 , wherein the phosphodiesterase type 5 inhibitor is lodenafil. 
     
     
         182 . The transdermal patch of  claim 170 , wherein the phosphodiesterase type 5 inhibitor is mirodenafil. 
     
     
         183 . The transdermal patch of  claim 170 , wherein the phosphodiesterase type 5 inhibitor is tadalafil. 
     
     
         184 . The transdermal patch of  claim 170 , wherein the phosphodiesterase type 5 inhibitor is vardenafil. 
     
     
         185 . The transdermal patch of  claim 170 , wherein the phosphodiesterase type 5 inhibitor is udenafil. 
     
     
         186 . The transdermal patch of  claim 170 , wherein the phosphodiesterase type 5 inhibitor is acetildenafil. 
     
     
         187 . The transdermal patch of  claim 170 , wherein the phosphodiesterase type 5 inhibitor is thiomethisosildenafil. 
     
     
         188 . The transdermal patch of  claim 170 , wherein the composition is stable when exposed to a temperature of 40° C. for at least about 4 weeks. 
     
     
         189 . The transdermal patch of  claim 170 , wherein the composition further comprises a penetration agent. 
     
     
         190 . The transdermal patch of  claim 170 , wherein the composition comprises citric acid. 
     
     
         191 . The transdermal patch of  claim 170 , wherein the composition has an ionic strength of at least about 1 M. 
     
     
         192 . The transdermal patch of  claim 170 , wherein the composition has a pH of between about 5 and about 9. 
     
     
         193 . The transdermal patch of  claim 170 , wherein the composition is capable of driving the phosphodiesterase type 5 inhibitor and/or salt thereof through stratum corneum. 
     
     
         194 . The transdermal patch of  claim 170 , wherein the stabilization polymer is present at at least about 0.5% by weight of the composition. 
     
     
         195 . The transdermal patch of  claim 170 , wherein the propylene glycol is present at at least about 1% by weight of the composition. 
     
     
         196 . The transdermal patch of  claim 170 , wherein the polysorbate surfactant is present at at least about 1% by weight of the composition. 
     
     
         197 . The transdermal patch of  claim 170 , wherein the phosphodiesterase type 5 inhibitor and/or salt thereof is present at at least about 0.1% by weight of the composition. 
     
     
         198 . A method, comprising applying the transdermal patch of  claim 170  to a subject. 
     
     
         199 . The method of  claim 198 , wherein the subject is human.