Transdermal delivery of beneficial substances effected by a hostile biophysical environment

Abstract

The present invention generally relates to the transdermal delivery of substances and, in some embodiments, to the transdermal delivery of beneficial substances by a hostile biophysical environment. In one aspect, various methods for the transdermal delivery of beneficial substances are disclosed. By creating a hostile biophysical environment, beneficial substances may be delivered, according to certain embodiments, through the stratum corneum of the skin into the body. Beneficial substances include, but are not limited to, pharmaceutical agents, drugs, vitamins, co-factors, peptides, dietary supplements, and others. The beneficial effects disclosed include, for instance, relief of pain and inflammation, prevention and healing of ulcers of the skin, relief of headache, improved sexual function and enjoyment, growth of hair on the scalp, improving muscle size and/or function, removing body fat and/or cellulite, treating cancer, treating viral infections and others. A hostile biophysical environment may also be used in conjunction with systems and methods for increasing local blood flow, according to one set of embodiments. For example, by using a nitric oxide donor such as L-arginine, local blood flow may be increased, e.g., by transdermally delivering the nitric oxide precursor. The nitric oxide donor may be the sole cause of increased blood flow, or it may be supplemented with an adjunct such as theophylline.

What is claimed is: 
     
         1 . A topical delivery vehicle, comprising:
 a nitric oxide donor; and   a pharmaceutical agent comprising sildenafil,   wherein the topical delivery vehicle has an ionic strength of between about 0.25 M and about 15 M.   
     
     
         2 . (canceled) 
     
     
         3 . The topical delivery vehicle of  claim 1 , wherein the nitric oxide donor comprises L-arginine. 
     
     
         4 . The topical delivery vehicle of  claim 1 , wherein the nitric oxide donor comprises L-arginine hydrochloride. 
     
     
         5 . The topical delivery vehicle of  claim 1 , wherein the nitric oxide donor comprises an L-arginine salt. 
     
     
         6 . The topical delivery vehicle of  claim 1 , wherein the topical delivery vehicle comprises an ionic salt. 
     
     
         7 . The topical delivery vehicle of  claim 6 , wherein the ionic salt comprises one or more of sodium chloride, choline chloride, magnesium chloride, lithium chloride, and calcium chloride. 
     
     
         8 . The topical delivery vehicle of  claim 1 , wherein the topical delivery vehicle has a pH of between about 3 and about 11. 
     
     
         9 . The topical delivery vehicle of  claim 1 , wherein the topical delivery vehicle comprises citric acid. 
     
     
         10 . The topical delivery vehicle of  claim 1 , wherein the ionic strength is at least 1 M. 
     
     
         11 . The topical delivery vehicle of  claim 1 , wherein the topical delivery vehicle is contained within a condom. 
     
     
         12 . The topical delivery vehicle of  claim 11 , wherein the topical delivery vehicle further comprises a lubricant. 
     
     
         13 . The topical delivery vehicle of  claim 1 , wherein the topical delivery vehicle is a cream. 
     
     
         14 . The topical delivery vehicle of  claim 1 , wherein the topical delivery vehicle is a gel. 
     
     
         15 . The topical delivery vehicle of  claim 1 , wherein the topical delivery vehicle is a lotion. 
     
     
         16 . A topical delivery vehicle having an ionic strength of at least about 1 M and comprising sildenafil, citric acid, and a nitric oxide donor selected from the group consisting of L-arginine and L-arginine hydrochloride. 
     
     
         17 . The topical delivery vehicle of  claim 16 , wherein the topical delivery vehicle is a cream. 
     
     
         18 . The topical delivery vehicle of  claim 16 , wherein the nitric oxide donor is present at a concentration of at least 0.5% by weight/volume. 
     
     
         19 . The topical delivery vehicle of  claim 16 , wherein the topical delivery vehicle is contained within a condom. 
     
     
         20 . A method, comprising:
 administering a topical delivery vehicle to the genitals of a human subject, the topical delivery vehicle having an ionic strength of at least about 1 M and comprising sildenafil, and a nitric oxide donor selected from the group consisting of L-arginine and L-arginine hydrochloride.   
     
     
         21 - 22 . (canceled) 
     
     
         23 . The method of  claim 20 , wherein the nitric oxide donor is present at a concentration of at least 0.5% by weight/volume. 
     
     
         24 . The method of  claim 20 , wherein the topical delivery vehicle comprises citric acid. 
     
     
         25 . The method of  claim 20 , wherein the human subject is male and the genitals is the penis. 
     
     
         26 . The method of  claim 25 , comprising applying a condom to the penis, wherein the condom comprises the topical delivery vehicle, thereby administering the topical delivery vehicle to the penis of the male human subject. 
     
     
         27 . The method of  claim 20 , wherein the topical delivery vehicle is a cream.