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 - 8 . (canceled)  
     
     
         9 . A crystalline Form A of aripiprazole hydrochloride characterized by an x-ray powder diffraction pattern having peaks expressed as 2θ at about 6.2, 8.5, 11.5, 15.2, 15.5, 16.8, 17.2, 18.3, 18.9, 19.6, 20.6, 21.3, 23.4, 24.1, 24.7, 25.9, 27.5, 28.3, 28.9, 32.8 degrees.  
     
     
         10 . A crystalline aripiprazole hydrochloride, characterized by an x-ray powder diffraction pattern as in  FIG. 3 .  
     
     
         11 . A process for preparation of Form A of aripiprazole hydrochloride of  claim 9 , comprising the steps of: 
 a) dissolving aripiprazole in methanol or isopropyl alcohol;    b) adding hydrochloric acid;    c) maintaining for about 1 hour to 3 hours at about 15° C. to 25° C.;    d) filtering the solid separated.    
     
     
         12 . A process according to  claim 11 , wherein aripiprazole is dissolved in methanol.  
     
     
         13 . A process according to  claim 11 , wherein aripiprazole is dissolved in isopropyl alcohol.  
     
     
         14 - 28 . (canceled)  
     
     
         29 . A pharmaceutical composition comprising a crystalline form of aripiprazole hydrochloride and a pharmaceutically acceptable carrier.  
     
     
         30 . (canceled)