Treatment of nail infections with no

Abstract

Nitrogen oxide generating compositions are useful in the treatment of subungual infections, as NO has surprisingly been found to be able to penetrate the nail to exert an anti-fungal effect.

1 . A method for the treatment or prophylaxis of a subungual infection, the method comprising: 
 generating nitrogen oxide by combining a nitrite and an organic acid, wherein the nitrite and the organic acid are separately disposed from each other prior to being combined, and combining the nitrite and the organic acid forms a composition.    
     
     
         2 . The method according to  claim 1 , wherein the organic acid is present in sufficient quantity that the composition formed by combining the nitrite and the organic acid is at a pH of 5.5, or below.  
     
     
         3 . The method according to  claim 1 , wherein the organic acid is selected from: formic acid, malic acid, maleic acid, acetic acid, lactic acid, citric acid, benzoic acid, tartaric acid and salicylic acid, ascorbic acid, ascorbyl palmitate, and mixtures thereof.  
     
     
         4 . The method according to any preceding  claim 1 , wherein the nitrite is selected from the alkali metal nitrites and the alkaline earth metal nitrites.  
     
     
         5 . The method according to  claim 4 , wherein the nitrite is selected from: sodium, potassium, magnesium and barium nitrites.  
     
     
         6 . The method according to  claim 1 , wherein the organic acid comprises citric acid and the nitrite comprises sodium nitrite, at least one being present in an aqueous vehicle.  
     
     
         7 . The method according to  claim 1 , wherein the subungual infection is onychomycosis.  
     
     
         8 . The method according to  claim 1 , wherein the nitrite is formulated with an excipient selected from: Eudragits, carbopol, carboxymethylcellulose, hydroxymethylcellulose, and mixtures thereof.  
     
     
         9 . The method according to  claim 1 , wherein the organic acid is formulated with an excipient selected from: carbopol, carboxymethylcellulose, hydroxymethylcellulose, methylcellulose, and mixtures thereof.  
     
     
         10 . The method according to  claim 1 , wherein the organic acid and the nitrite are separately disposed in aqueous based formulations prior to being combined.  
     
     
         11 . The method according to  claim 10 , wherein each preparation is in a form separately selected from gels, creams, lotions, ointments and paints suitable for mixing each with the other.  
     
     
         12 . The method according to  claim 1 , wherein the organic acid and the nitrite are each separately formulated as a gel, paint or lacquer prior to being combined.  
     
     
         13 . The method according to  claim 1 , wherein, prior to being combined, the organic acid and the nitrite are each separately formulated as a liquid or gel which, when mixed, solidify or form a gel or paint.  
     
     
         14 . The method according to  claim 1 , wherein the nitrite is approximately 0.5 to 30%, by weight, of the composition formed by combining the nitrite and the organic acid.  
     
     
         15 . The method according to  claim 14 , wherein the nitrite is 5 to 15%, by weight, of the composition formed by combining the nitrite and the organic acid.  
     
     
         16 . The method according to  claim 1 , wherein the organic acid is approximately 5 to 30%, by weight, of the composition formed by combining the nitrite and the organic acid.  
     
     
         17 . The method according to  claim 16 , wherein the organic acid is approximately 10 to 15%, by weight, of the composition formed by combining the nitrite and the organic acid.  
     
     
         18 . (Cancelled).  
     
     
         19 . The method according to  claim 1 , wherein the composition formed by combining the nitrite and the organic acid is applied to an infected nail in an effective amount.  
     
     
         20 . A kit comprising: 
 a nitrite; and    an organic acid kept separate from the nitrite,    wherein the kit is configured so that the nitrite and the organic acid can be combined to generate nitrogen oxide, and the nitrogen oxide can be used for the treatment or prophylaxis of a subungual infection.    
     
     
         21 . A kit according to  claim 20 , comprising an aqueous preparation of the nitrite and an aqueous preparation of the organic acid, separately disposed one from each other, the two preparations each being suitable to apply to a nail to be treated such that the nitrite and acid can react to release nitrogen oxides for penetration into the nail.  
     
     
         22 . A kit according to  claim 21 , wherein each preparation is in a form selected from lotions, gels, creams and lacquers.  
     
     
         23 . A kit according to  claim 21 , wherein the preparations are provided in resealable containers.