Novel crystalline forms of aripiprazole

Abstract

The present invention provides novel crystalline forms of aripiprazole and aripiprazole hydrochloride, processes for their preparation and pharmaceutical compositions containing them.

1 - 18 . (canceled) 
     
     
         19 . A crystalline Form C of aripiprazole hydrochloride characterized by an x-ray powder diffraction pattern having peaks expressed as 2θ at about 3.3, 10.3, 14.2, 14.6, 15.1, 16.4, 16.6, 19.4, 20.3, 20.8, 24.5, 24.9, 25.5, 26.4, 26.7, 28.5, 29.3, 30.1 degrees. 
     
     
         20 . A crystalline aripiprazole hydrochloride, characterized by an x-ray powder diffraction pattern as in  FIG. 5 . 
     
     
         21 . A process for preparation of Form C of aripiprazole hydrochloride of  claim 19 , comprising the steps of:
 a) dissolving aripiprazole in an ester solvent;   b) adding hydrochloric acid;   c) maintaining for about 1 hour to 4 hours at about 15° C. to 25° C.; and   d) filtering the separated solid;   wherein the ester solvent is selected from the group consisting of ethyl acetate, methyl acetate, ethyl formate and tert-butyl acetate.   
     
     
         22 . A process according to  claim 21 , wherein the ester solvent is ethyl acetate. 
     
     
         23 . A process according to  claim 21 , wherein the ester solvent is methyl acetate.