Polymorphic form of pyrrole derivative and intermediate thereof

Abstract

The present invention relates to Saroglitazar free acid of Formula (IA) or its pharmaceutically acceptable salts, pharmaceutically acceptable solvates, pharmaceutically acceptable esters, stereoisomers, tautomers, analogs and derivatives thereof. The present invention also provides an amorphous form of saroglitazar free acid and processes of preparation thereof. The present invention also provides pharmaceutical composition comprising an amorphous form saroglitazar magnesium.

1 - 4 . (canceled) 
     
     
         5 . An amorphous form of saroglitazar magnesium of Formula (I): 
       
         
           
           
               
               
           
         
       
     
     
         6 . The amorphous form of saroglitazar magnesium according to  claim 5  having a purity of at least about 98% by area percentage of HPLC and less than about 0.5% residual solvent. 
     
     
         7 . The amorphous form of saroglitazar magnesium according to  claim 5  having an X-ray powder diffraction pattern substantially the same as that shown in  FIG. 2 . 
     
     
         8 - 17 . (canceled) 
     
     
         18 . The amorphous form of saroglitazar magnesium according to  claim 6  having particle size distributions having D(10) of about 20 μm or less, D(50) of about 100 μm or less, and D(90) of about 200 μm or less, or any combination thereof. 
     
     
         19 - 31 . (canceled) 
     
     
         32 . The amorphous form of saroglitazar magnesium according to  claim 5  having a purity of at least about 98% by area percentage of HPLC. 
     
     
         33 . The amorphous form of saroglitazar magnesium according to  claim 5  having a chiral purity of at least about 98% by area percentage of HPLC. 
     
     
         34 - 37 . (canceled) 
     
     
         38 . A pharmaceutical composition comprising an amorphous form of saroglitazar magnesium, wherein the amorphous form of saroglitazar magnesium has particle size distributions having D(10) of about 20 μm or less, D(50) of about 100 μm or less, and D(90) of about 200 μm or less, or any combination thereof. 
     
     
         39 . A pharmaceutical composition comprising an amorphous form of saroglitazar magnesium, together with one or more pharmaceutically acceptable carriers, excipients or diluents.