Crystalline forms of atorvastatin

Abstract

The present invention is directed to new crystalline forms of Atorvastatin calcium (2:1), referred to hereinafter as polymorphic Forms X, A, B1, B2, C, D and E. Furthermore, the present invention is directed to processes for the preparation of these crystalline forms and pharmaceutical compositions comprising the crystalline forms.

1 . (canceled)  
     
     
         2 . A crystalline form of [R—(R*,R*)-2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid calcium salt that has the X-ray powder diffraction pattern with characteristic peaks expressed in d-values (Å) at 
       31.0 (vw), 18.6 (m), 17.0 (w), 15.3 (vw), 12.8 (w), 11.2 (m), 9.6 (s), 9.3 (w), 8.6 (w), 7.4 (m), 6.5 (vw), 6.2 (vw), 5.47 (w), 5.21 (m), 4.64 (vs), 4.46 (s), 4.14 (m), 3.97 (m), 3.74 (m), 3.62 (vw), 3.38 (w), 3.10 (m); 
       wherein (vs)=very strong intensity; (s)=strong intensity; (m)=medium intensity; (w)=weak intensity; (vw)=very weak intensity.  
     
     
         3 - 8 . (canceled)  
     
     
         9 . A process for the preparation of a crystalline form according to  claim 2 , which comprises suspending a crystalline form according to  claim 1  or amorphous Atorvastatin calcium in an alcohol containing a small amount of water and treating the suspension at a temperature between 10 and 60° C.  
     
     
         10 - 14 . (canceled)  
     
     
         15 . A process for the preparation of a crystalline form according to  claim 2 , which comprises treating a solution of Atorvastatin lactone in a mixture of isopropanol and water with calcium hydroxide.  
     
     
         16 . A pharmaceutical composition comprising an effective amount of a crystalline form according to  claim 2 , and a pharmaceutically acceptable carrier.