Antifungal nail coat and method of use

Abstract

Antifungal nail coat compositions containing an allylamine, an N,N-di(C 1 -C 8 ) alkylamino substituted, (C 4 -C 18 ) alkyl (C 2 -C 18 ) carboxylic ester or a pharmaceutically acceptable acid addition salt thereof, a hydrophilic polymer, and a pharmaceutically acceptable, volatile organic carrier are disclosed. The composition provides a substantially water-soluble, fungicidal coating upon contact with a fungally susceptible or infected nail.

1 - 22 . (canceled) 
     
     
         23 . A method for ameliorating or preventing fungal infection of a toenail or fingernail comprising contacting a fungally susceptible or infected nail and skin tissue adjacent thereto with a nail coat composition consisting essentially of, on a total composition weight basis:
 about 0.5 to about 10 weight percent terbinafine hydrochloride:   about 0.1 to about 25 weight percent dodecyl-2-(N,N-dimethylamino) isopropionate hydrochloride:   about 0.1 to about 10 weight perecent benzyl alcohol;   about 0.1 to about 5 weight percent polyvinylpyrrolidone; and   the remainder ethanol.   
     
     
         24 . The method according to  claim 23  wherein the contact is maintained for a period of at least about 0.5 hours. 
     
     
         25 . The method according to  claim 23  wherein the method is performed at least once a day. 
     
     
         26 . The method according to  claim 24  wherein the method is performed at least once a day. 
     
     
         27 . The method according to  claim 23 , wherein the method is practiced daily until new nail growth is free of fungal infection. 
     
     
         28 . The method according to  claim 24 , wherein the method is practiced daily until new nail growth is free of fungal infection. 
     
     
         29 . The method according to  claim 23 , wherein the composition is applied by brushing or spraying. 
     
     
         30 . The method according to  claim 23 , wherein the nail coat composition consists essentially of, on a total composition weight basis:
 about 10 weight percent terbinafine hydrochloride:   about 0.5 weight percent dodecyl-2-(N,N-dimethylamino) isopropionate hydrochloride:   about 0.75 weight perecent benzyl alcohol;   about 0.5 weight percent polyvinylpyrrolidone; and   the remainder ethanol.