Topical pharmaceutical composition in the form of aqueous gel comprising at least amitriptyline

Abstract

The present invention relates to a topical pharmaceutical composition in the form of an aqueous gel comprising at least amitriptyline and/or a pharmaceutically acceptable salt thereof with a content between 10 and 30% by weight relative to the total weight of the composition, and water.

1 . Pharmaceutical composition in the form of an aqueous gel for topical application comprising:
 (i) at least amitriptyline and/or a pharmaceutically acceptable salt thereof, the total content of amitriptyline and/or a pharmaceutically acceptable salt thereof being between 10 and 30% by weight relative to the total weight of the composition; and   (ii) water.   
     
     
         2 . Composition according to  claim 1 , characterised in that the total content of amitriptyline and/or a pharmaceutically acceptable salt thereof is between 10 and 25% by weight, relative to the total weight of the composition. 
     
     
         3 . Composition according to  claim 1 , characterised in that it comprises at least one cellulosic polymer. 
     
     
         4 . Composition according to  claim 4 , characterised in that the cellulosic polymer(s) have an average molecular weight of between 5 000 and 1 500 000. 
     
     
         5 . Composition according to  claim 3 , characterised in that the cellulosic polymer(s) are selected from cellulose ethers. 
     
     
         6 . Composition according to  claim 3 , characterised in that the total content of cellulosic polymer(s) is between 0.1 and 10% by weight, relative to the total weight of the composition. 
     
     
         7 . Composition according to  claim 1 , characterised in that it comprises at least one C 2 -C 8  polyol. 
     
     
         8 . Composition according to  claim 7 , characterised in that the C 2 -C 8  polyol(s) are selected from C 3 -C 6  polyols, ethylene glycol, and mixtures thereof. 
     
     
         9 . Composition according to  claim 7 , characterised in that the total content of C 2 -C 8  polyol(s) is between 0.1 and 15% by weight, relative to the total weight of the composition. 
     
     
         10 . Composition according to  claim 1 , characterised in that the viscosity, at a temperature of 20° C. and at atmospheric pressure, is between 400 and 2500 mPa·s. 
     
     
         11 . Composition according to  claim 1 , characterised in that it is free of sequestering and/or anti-oxidant agents. 
     
     
         12 . Composition according to  claim 1 , characterised in that the pH is between 3 and 8. 
     
     
         13 . Composition according to  claim 1 , characterised in that the content of water is greater than or equal to 65% by weight, relative to the total weight of the composition. 
     
     
         14 . Composition according to  claim 1 , characterised in that it is free of fatty substance. 
     
     
         15 . Composition according to  claim 1 , for use as a drug. 
     
     
         16 . Composition according to  claim 1 , for topical use in the treatment of neuropathic pain. 
     
     
         17 . Composition according to  claim 1 , for use in the treatment of cancers comprising chemotherapy sessions, the composition being administered topically between the chemotherapy sessions to cure or prevent neuropathic pain that may be induced by chemotherapy. 
     
     
         18 . Composition according to  claim 1  for topical use in the treatment of erythromelalgia.