Novel composition and method for stabilizing the same

Abstract

Disclosed is a novel composition comprising a novel bi-cyclic compound, which is expected to be pharmaceutically active, and a glyceride. The stability of the bi-cyclic compound can be improved significantly by dissolving the same in a glyceride.

1 . A pharmaceutical composition for oral administration comprising:
 i. the following bicyclic compound,   
       
         
           
           
               
               
           
         
         7-[(1R,6R,7R)-3-[(3S)-1,1-difluoro-3-methylpentyl]-3-hydroxy-2-oxabicyclo[4.3.0]nonane-8-one-7-yl]heptanoic acid 
         ii. the monocyclic tautomer of said compound, and 
         iii. a physiologically acceptable additive, wherein the composition is suitable for oral administration, wherein the ratio of the bicyclic compound to the monocyclic tautomer in the pharmaceutical composition is at least 90:10, wherein the composition is substantially free of water. 
       
     
     
         2 . The composition according to  claim 1 , wherein the ratio of bi-cyclic compound to mono-cyclic tautomer is at least about 96:4. 
     
     
         3 . The composition according to  claim 1 , wherein the ratio of bi-cyclic compound to mono-cyclic tautomer is substantially 100:0. 
     
     
         4 . The composition according to  claim 1 , which is formulated as a capsule. 
     
     
         5 . The composition according to  claim 1 , wherein said additive is an oil solvent other than glyceride. 
     
     
         6 . The composition according to  claim 5 , wherein said oil solvent is mineral oil.