Orlistat compositions

Abstract

A pharmaceutical combination or composition containing a lipase inhibitor, preferably orlistat, and a bile acid sequestrant is useful for treating obesity.

1 . A pharmaceutical composition which consists essentially of orlistat and a pharmaceutically acceptable bile acid sequestrant selected from the group consisting of cholestyramine-, and colestipol, and optionally comprises excipients.  
     
     
         2 . The composition according to  claim 1 , wherein the bile acid sequestrant is cholestyramine.  
     
     
         3 . The composition according to  claim 1 , wherein the bile acid sequestrant is colestipol.  
     
     
         4 . The composition according to  claim 1 , wherein the composition consists essentially of (a) from about 5 to about 1000 mg of orlistat and (b) from about 0.1 to about 20 g of the bile acid sequestrant, and optionally comprises excipients.  
     
     
         5 . The composition according to  claim 4 , which consists essentially of: 
 (a) from about 5 to about 1000 mg of orlistat;    (b) from about 0.1 to about 20 g bile acid sequestrant;    (c) from about 0.1 to about 10 g of a filler;    (d) from about 0.05 to about 3.0 g of a surfactant;    (e) from about 0.05 to about 2.0 g of a disintegrant;    (f) from about 0.02 to about 2.0 g of a binder;    (g) from about 0.001 to about 1.0 g of a lubricant;    (h) from about 0.1 to about 5.0 g of a flowability enhancer;    (i) from about 0.01 to about 4.0 g of a sweetener; and    (j) and about 0.001 to about 0.5 g of a colorant.    
     
     
         6 . The composition according to  claim 4 , wherein the orlistat is present in an amount of from about 10 to about 500 mg.  
     
     
         7 . The composition according to  claim 6 , wherein the orlistat is present in an amount of 120 mg.  
     
     
         8 . The composition according to  claim 4 , wherein the orlistat is present in an amount of from about 20 to about 100 mg.  
     
     
         9 . The composition according to  claim 8 , wherein the orlistat is present in an amount of 60 mg.  
     
     
         10 . The composition according to  claim 4 , wherein the bile acid sequestrant is present in an amount of from about 0.5 to about 10 g.  
     
     
         11 . The composition according to  claim 10 , wherein the bile acid sequestrant is present in an amount of from about 1 to about 5 g.  
     
     
         12 . A kit for use in the treatment of obesity, which comprises (a) a first component consisting essentially of orlistat and (b) a second component consisting essentially of a bile acid sequestrant selected from the group consisting of cholestyramine and colestipol present in oral unit dosage form.