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 - 115 . (canceled) 
     
     
         116 . A composition, comprising:
 a topical delivery vehicle comprising a nitric oxide donor, and acyclovir at a dosage effective to treat a medical condition, the topical delivery vehicle having an ionic strength of between about 0.25 M and about 15 M.   
     
     
         117 . The composition of  claim 116 , wherein the nitric oxide donor comprises L-arginine and/or L-arginine hydrochloride. 
     
     
         118 . The composition of  claim 116 , wherein the nitric oxide donor comprises an L-arginine salt. 
     
     
         119 . The composition of  claim 116 , wherein the nitric oxide donor comprises an L-arginine derivative. 
     
     
         120 . The composition of  claim 119 , wherein the derivative of L-arginine is selected from the group consisting of D,L-arginine, D-arginine, an alkyl ester of L-arginine, an alkyl ester of D-arginine, an L-arginine salt, a D-arginine salt, an alkyl ester salt of L-arginine, an alkyl ester salt of D-arginine, L-arginine glutamate, L-arginine butyrate, L-arginine glycolate, D-arginine hydrochloride, D-arginine glutamate; L-homoarginine, N-hydroxy-L-arginine, nitrosylated L-arginine, nitrosylated L-arginine, nitrosylated N-hydroxy-L-arginine, nitrosylated N-hydroxy-L-arginine, and combinations thereof. 
     
     
         121 . The composition of  claim 116 , wherein the nitric oxide donor is present at a concentration of at least 0.5% by weight/volume. 
     
     
         122 . The composition of  claim 116 , wherein the topical delivery vehicle comprises sodium chloride. 
     
     
         123 . The composition of  claim 116 , wherein the topical delivery vehicle comprises one or more of lithium chloride, potassium chloride, calcium chloride, magnesium chloride, choline chloride, sodium fluoride and lithium bromide. 
     
     
         124 . The composition of  claim 116 , wherein the ionic salt has an ionic strength of at least about 1 M. 
     
     
         125 . The composition of  claim 116 , wherein the topical delivery vehicle comprises citric acid. 
     
     
         126 . The composition of  claim 116 , wherein the topical delivery vehicle is a cream. 
     
     
         127 . The composition of  claim 116 , wherein the topical delivery vehicle is a gel. 
     
     
         128 . The composition of  claim 116 , wherein the topical delivery vehicle is a lotion. 
     
     
         129 . A composition, comprising:
 a topical delivery vehicle comprising:   (a) an ionic salt having an ionic strength of between about 0.25 M and about 15 M,   (b) L-arginine and/or L-arginine hydrochloride and/or a derivative of L-arginine, and   (c) acyclovir.   
     
     
         130 . The composition of  claim 129 , wherein the topical delivery vehicle comprises L-arginine and/or L-arginine hydrochloride. 
     
     
         131 . The composition of  claim 129 , wherein the nitric oxide donor comprises an L-arginine salt. 
     
     
         132 . The composition of  claim 129 , wherein the nitric oxide donor comprises an L-arginine derivative. 
     
     
         133 . The composition of  claim 129 , wherein the L-arginine and/or L-arginine hydrochloride and/or a derivative of L-arginine is present at a concentration of at least 0.5% by weight/volume. 
     
     
         134 . The composition of  claim 129 , wherein the topical delivery vehicle comprises a derivative of L-arginine selected from the group consisting of D,L-arginine, D-arginine, an alkyl ester of L-arginine, an alkyl ester of D-arginine, an L-arginine salt, a D-arginine salt, an alkyl ester salt of L-arginine, an alkyl ester salt of D-arginine, L-arginine glutamate, L-arginine butyrate, L-arginine glycolate, D-arginine hydrochloride, D-arginine glutamate; L-homoarginine, N-hydroxy-L-arginine, nitrosylated L-arginine, nitrosylated L-arginine, nitrosylated N-hydroxy-L-arginine, nitrosylated N-hydroxy-L-arginine, and combinations thereof. 
     
     
         135 . The composition of  claim 129 , wherein the ionic salt comprises sodium chloride. 
     
     
         136 . The composition of  claim 129 , wherein the ionic salt comprises one or more of lithium chloride, potassium chloride, calcium chloride, magnesium chloride, choline chloride, sodium fluoride and lithium bromide. 
     
     
         137 . The composition of  claim 129 , wherein the ionic salt has an ionic strength of at least about 1 M. 
     
     
         138 . The composition of  claim 129 , wherein the topical delivery vehicle comprises citric acid. 
     
     
         139 . The composition of  claim 129 , wherein the topical delivery vehicle is a cream.