Oil-free pharmaceutical compositions containing cyclosporin A

Abstract

The present invention provides a hard gelatine capsule containing a pharmaceutical composition comprising cyclosporin A in a mixture with a surfactant of HLB value at least 10, substantially free of any oil and when a hydrophilic phase is present, the hydrophilic phase being a polyethylene glycol and/or a lower alkanol provided that any lower alkanol present is present in less than 12% of the total weight of the composition absent the hard gelatine capsule.

1 . A hard gelatine capsule containing a pharmaceutical composition comprising cyclosporin A in a mixture with a surfactant of HLB value at least 10, substantially free of any oil and when a hydrophilic phase is present, the hydrophilic phase being a polyethylene glycol and/or a lower alkanol provided that any lower alkanol present is present in less than 12% of the total weight of the composition absent the hard gelatine capsule.  
     
     
         2 . A hard gelatine capsule as defined in  claim 1  wherein the lower alkanol present is present in less than 8% of the total weight of the composition absent the hard gelatine capsule.  
     
     
         3 . A hard gelatine capsule as defined in  claim 1  or  2  wherein the surfactant is a polyoxyethylene-sorbitan-fatty acid ester.  
     
     
         4 . A hard gelatine capsule as defined in any preceding claim further comprising a thickening agent which is capable of dissolving in the stomach juices or water.  
     
     
         5 . A hard gelatine capsule as defined in any preceding claim wherein cyclosporin is present in an amount of from 10 to 25% by weight based on the total weight of the composition absent the hard gelatine capsule.  
     
     
         6 . A hard gelatine capsule as defined in any preceding claim comprising further excipients apart from the surfactant and as thickening agent in an amount of from 0.1 to 5% by weight based on the total weight of the composition absent the hard gelatine capsule.  
     
     
         7 . A hard gelatine capsule as defined in any preceding claim wherein the hydrophilic phase is present.  
     
     
         8 . A hard gelatine capsule as defined in  claim 7  claim wherein the hydrophilic phase is polyethylene glycol and/or propylene glycol.  
     
     
         9 . A hard gelatine capsule as defined in  claim 7  wherein the hydrophilic phase is polyethylene glycol and/or ethanol.  
     
     
         10 . A hard gelatine capsule as defined in  claim 1  containing a hydrophilic phase which comprises polyethylene glycol and/or a lower alkanol as defined in  claim 1  and when any polyethylene glycol is present this polyethylene glycol is liquid when heated to 37° and the surfactant is a polyoxyethylene sorbitan fatty acid ester or a polyethyloxylated castor oil or a polyoxyethylene fatty acid ester.  
     
     
         11 . A hard gelatine capsule as defined in  claim 10  wherein the pharmaceutical composition is semi-solid or liquid with the cyclosporin dissolved therein.