Polymorphic forms of ziprasidone HCl and processes for their preparation

Abstract

Provided are various polymorphic forms of ziprasidone HCl and processes for their preparation.

1 . A crystalline form of ziprasidone HCl (Form F), wherein the crystalline form is characterized by a powder XRD pattern with peaks at 111.0, 18.1, 19.5, 21.9±0.2 degrees 2 theta.  
     
     
         2 . The crystalline form of  claim 1 , wherein the crystalline form is further characterized by peaks at 14.9, 24.9, 26.1±0.2 degrees two-theta.  
     
     
         3 . The crystalline form of  claim 2 , wherein the crystalline form is further characterized by an XRD pattern as substantially depicted in  FIG. 7 .  
     
     
         4 . A process for preparing the ziprasidone HCl of  claim 1 , comprising: 
 a) combining aqueous HCl with ziprasidone base in a solvent selected from the group consisting of methylethylketone, tetrahydrofuran and dimethylacetamide to obtain a slurry;    b) maintaining the slurry to obtain ziprasidone HCl; and    c) recovering the ziprasidone HCl.    
     
     
         5 . The process of  claim 4 , wherein the slurry is diluted by addition of water.  
     
     
         6 . The process of  claim 4 , wherein the ziprasidone base is ziprasidone Form B.  
     
     
         7 . The process of  claim 4 , wherein the slurry is carried out at a temperature of at least about 40 EC.  
     
     
         8 . Crystalline form of ziprasidone HCl prepared by the process of  claim 4 .  
     
     
         9 . A pharmaceutical composition comprising crystalline ziprasidone HCL of  claim 1  and at least one pharmaceutically acceptable excipient.  
     
     
         10 . A method of treating a patient suffering from schizophrenia comprising administering to the patient the pharmaceutical composition of  claim 9.