Plaster for topical use containing heparin and diclofenac

Abstract

Plaster for topical use having an analgesic activity and at the same time being able to re-absorb haematomas, comprising: a substrate layer; an adhesive layer in the form of a hydrogel matrix containing a pharmaceutically acceptable diclofenac salt, heparin or a heparinoid; a protective film which can be removed at the moment of use.

1 . Plaster for topical use having an analgesic activity and at the same time being able to re-absorb haematomas, comprising: 
 a) a substrate layer;    b) an adhesive layer in the form of a hydrogel matrix containing a pharmaceutically acceptable diclofenac salt and heparin or a heparinoid;    c) a protective film which can be removed at the moment of use.    
     
     
         2 . The plaster according to  claim 1 , wherein the diclofenac salt is in the form of a salt with an alicyclic amine of general formula:  
       
         
           
           
               
               
           
         
       
       in which m is 0 or 1.  
     
     
         3 . The plaster according to  claim 1 , wherein the diclofenac salt used in the plaster according to the present invention is N-hydroxyethyl pyrrolidine (epolamine).  
     
     
         4 . The plaster according to  claim 1 , wherein the diclofenac salt is contained in concentrations of between 0.1 and 5 wt % with respect to the total weight of the compositions used for the preparation of the hydrogel matrix.  
     
     
         5 . The plaster according to  claim 4 , wherein the said concentration is between 0.3 and 3 wt % with respect to the total weight of the composition used for the preparation of the matrix.  
     
     
         6 . The plaster according to  claim 1 , in which heparin or heparinoid is contained in such concentrations in the composition used for the preparation of the hydrogel matrix that the total content of sodium heparin or heparinoid contained in the plaster is between 0.05 and 1 wt % with respect to the total weight of the hydrogel matrix.  
     
     
         7 . The plaster according to  claim 1 , wherein the pH of the composition used for the preparation of the hydrogel matrix is between 7.2 and 9.  
     
     
         8 . The plaster according to  claim 7 , wherein the said pH is between 7.5 and 8.5.  
     
     
         9 . The plaster according claims  1 , wherein the composition used for the preparation of the hydrogel matrix contains at least one thickening agent chosen from among the group consisting of polyacrylic acid, sodium polyacrylate, sodium carboxymethyl cellulose, polyvinyl alcohol, polyvinyl pyrrolidone, gelatine or corresponding mixtures.  
     
     
         10 . The plaster according to  claim 9 , wherein the concentration of the said thickening agent in the composition used for the preparation of the hydrogel matrix is between 3 and 30 wt %.  
     
     
         11 . The plaster according to  claim 10 , wherein the said concentration is between 5 and 20 wt % with respect to the total weight of the composition used for the preparation of the hydrogel matrix.  
     
     
         12 . The plaster according to  claim 1 , wherein the composition used for the preparation of the hydrogel matrix contains at least one wetting agent chosen from among the group consisting of glycerol, propylene glycol, polyethylene glycol, 1,3-butanediol, and an aqueous solution of D-sorbitol, preferably in a concentration of 70%.  
     
     
         13 . The plaster according to  claim 12 , wherein the concentration of wetting agents is between 10 and 60 wt % with respect to the total weight of the composition used for the preparation of the hydrogel matrix.  
     
     
         14 . The plaster according to  claim 1 , wherein the composition used for the preparation of the hydrogel matrix contains at least one cross-linking agent at concentrations of between 0.01 and 3 wt % with respect to the total weight of the composition.