Compositions for oral administration of active principles requiring masking of taste

Abstract

Composition intended for the oral administration of active principles with unacceptable taste, which comprises from about 15% to about 30% of active ingredient (principle) mixed with from about 60% to about 80% of an ester of glycerol or of a fatty acid, to which a wax is optionally added and to which a surfactant is added, and in that it is prepared by a spray-cooling process which can produce a particle size of less than 350 μm.

1 . A composition intended for the oral administration of active ingredients with unacceptable taste, which comprises from about 15 to about 30% of active ingredient mixed with from about 60% to about 80% of an ester of glycerol or of a fatty acid, to which a wax is optionally added, and to which a surfactant is added, and wherein the composition is prepared by a spray-cooling process which can produce a particle size of less than about 350 μm.  
     
     
         2 . The composition as set forth in  claim 1 , wherein the ester of glycerol is chosen from glyceryl stearate or glyceryl palmitostearate.  
     
     
         3 . The composition as set forth in  claim 1 , wherein the ester of glycerol is present between about 50% and about 85% by weight of the total mixture of the composition.  
     
     
         4 . The composition as set forth in  claim 1 , wherein the ester of glycerol is present between about 60% and about 80% by weight of the total mixture of the composition.  
     
     
         5 . The composition as set forth in  claim 2 , wherein the ester of glycerol is present between about 60% and about 80% by weight of the total mixture of the composition.  
     
     
         6 . The composition as set forth in  claim 3 , wherein the ester of glycerol is present between about 60% and about 80% by weight of the total mixture of the composition.  
     
     
         7 . The composition as set forth in  claim 1 , wherein the ester of glycerol is present between about 70% and about 80% by weight of the total mixture of the composition.  
     
     
         8 . The composition as set forth in  claim 2 , wherein the ester of glycerol is present between about 70% and about 80% by weight of the total mixture of the composition.  
     
     
         9 . The composition as set forth in  claim 3 , wherein the ester of glycerol is present between about 70% and about 80% by weight of the total mixture of the composition.  
     
     
         10 . The composition as set forth in  claim 4 , wherein the ester of glycerol is present between about 70% and about 80% by weight of the total mixture of the composition.  
     
     
         11 . The composition as set forth in  claim 1 , wherein the active ingredient is a pharmaceutically active ingredient.  
     
     
         12 . The composition as set forth in  claim 2 , wherein the active ingredient is a pharmaceutically active ingredient.  
     
     
         13 . The composition as set forth in  claim 3 , wherein the active ingredient is a pharmaceutically active ingredient.  
     
     
         14 . The composition as set forth in  claim 4 , wherein the active ingredient is a pharmaceutically active ingredient.  
     
     
         15 . The composition as set forth in  claim 7 , wherein the active ingredient is a pharmaceutically active ingredient.  
     
     
         16 . A process for the preparation of a composition intended for the oral administration of active ingredients comprising: 
 mixing one or more active ingredients in a molten ester of glycerol;    optionally adding to the above molten mixture one or more excipients; and    spray-cooling the resulting molten mixture by spraying using a device equipped with a two-fluid nozzle at the top of a tower into which a cold gaseous counter-current is optionally introduced.    
     
     
         17 . The process as set forth in  claim 16 , wherein the device is further equipped with a fluidized bed.  
     
     
         18 . The process as set forth in  claim 16 , wherein the ester of glycerol is chosen from glyceryl stearate or glyceryl palmitostearate.  
     
     
         19 . The process as set forth in  claim 16 , wherein the ester of glycerol is present between about 50% and about 85% by weight of the total mixture of the composition.  
     
     
         20 . The process as set forth in  claim 16 , wherein the active ingredient is a pharmaceutically active ingredient.