Malic acid addition salts of terbinafine

Abstract

The invention concerns salts of the compound of formula I with malic acid, their preparation, corresponding pharmaceutical compositions and their use as antimycotics.

1 . A salt of the compound of formula I  
       
         
           
           
               
               
           
         
       
       with malic acid.  
     
     
         2 . A compound according to  claim 1  in the form of the L-(−)-hydrogen malate.  
     
     
         3 . A process for the preparation of a compound according to  claim 1  which comprises reacting the compound of formula I in free base form with an appropriate malic acid form and recovering from the reaction mixture the resultant salt.  
     
     
         4 . A pharmaceutical composition comprising a compound according to  claim 1  together with at least one pharmaceutically acceptable carrier or diluent.  
     
     
         5 . A pharmaceutical composition comprising the compound of formula I in free base form or pharmaceutically acceptable salt form other than a malic acid addition salt form, whenever prepared from a compound according to  claim 1 .  
     
     
         6 . A compound according to  claim 1  for use as a pharmaceutical.  
     
     
         7 . A compound according to  claim 1  for use in the preparation of a medicament.  
     
     
         8 . The compound of formula I in free base form or a salt form other than a malic acid addition salt form, whenever prepared from a compound according to  claim 1 .  
     
     
         9 . The use of a compound according to  claim 1  in the preparation of a medicament for the treatment of diseases susceptible of therapy with the compound of formula I in free base form or salt form.  
     
     
         10 . A method for the prophylactic or curative treatment of fungal diseases such as fungal sinusitis infection or onychomycosis, comprising administration of a therapeutically effective amount of a compound according to  claim 1  to a subject in need of such treatment.