Crystalline forms of palonosetron hydrochloride

Abstract

The present invention provides crystalline forms of Palonosetron hydrochloride, processes for their preparation and pharmaceutical compositions containing such crystalline forms of Palonosetron HCl.

1 - 25 . (canceled) 
     
     
         26 . A crystalline form of palonosetron hydrochloride (PAL-HCl), characterized by data selected from the group consisting of: a PXRD having peak reflections at about 12.1, 15.8 and 17.3±0.2 degrees two-theta, a PXRD pattern as depicted in  FIG. 2 , and a combination thereof. 
     
     
         27 . The crystalline form of PAL-HCl of  claim 26 , characterized by a PXRD having peak reflections at about 12.1, 15.8 and 17.3±0.2 degrees two-theta. 
     
     
         28 . The crystalline form of PAL-HCl of  claim 26 , characterized by a PXRD pattern as depicted in  FIG. 2 . 
     
     
         29 . The crystalline form of PAL-HCl of  claim 27 , further characterized by PXRD peak reflections at about 7.1, 13.8, 14.2, 14.5, 18.5, 20.0 and 30.3±0.2 degrees two-theta. 
     
     
         30 . The crystalline form of PAL-HCl of  claim 26 , further characterized by a DSC thermogram having an endothermic peak at about 313° C. 
     
     
         31 . The crystalline form of PAL-HCl of any of  claim 26 , further characterized by a weight loss of less than about 0.1% measured at temperatures less or equal to 152° C. by TGA. 
     
     
         32 . The crystalline form of PAL-HCl of any of  claim 26 , wherein the crystalline form is an anhydrous form of PAL-HCl. 
     
     
         33 . The crystalline form of PAL-HCl of any of  claim 26 , wherein the crystalline form has less than 20% of the crystalline form of Palonosetron hydrochloride characterized by data selected from the group consisting of: a PXRD having peak reflections at about 13.0, 15.4 and 17.5±0.2 degrees two-theta, a PXRD pattern as depicted in  FIG. 1 , and a combination thereof. 
     
     
         34 . A process preparing a crystalline form of PAL-HCl according to  claim 26 , comprising crystallizing Palonosetron hydrochloride having at least 96% of 3aS Palonosetron HCl of the following formula, 
       
         
           
           
               
               
           
         
       
       from a mixture of isopropanol and water at a temperature above 55° C. 
     
     
         35 - 50 . (canceled) 
     
     
         51 . A pharmaceutical composition comprising a crystalline form of PAL-HCL according to  claim 26  and a pharmaceutically acceptable excipient.