Bendamustine pharmaceutical compositions

Abstract

The present invention provides pharmaceutical formulations of lyophilized bendamustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized bendamustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.

What is claimed is: 
     
         1 . A lyophilized preparation of bendamustine or bendamustine hydrochloride containing not more than about 0.9% (area percent of bendamustine) of HP1: 
       
         
           
           
               
               
           
         
       
     
     
         2 . The lyophilized preparation of  claim 1  containing not more than about 0.5% (area percent of bendamustine) of HP1. 
     
     
         3 . The lyophilized preparation of  claim 1  containing not more than about 0.4% % (area percent of bendamustine) of HP1. 
     
     
         4 . The lyophilized preparation according to  claim 1  containing not more than about 0.5% (area percent of bendamustine) of a compound of Formula IV: 
       
         
           
           
               
               
           
         
       
     
     
         5 . The lyophilzed preparation according to  claim 1  containing less than or equal to 4.0% (area percent of bendamustine) of bendamustine degradants. 
     
     
         6 . The lyophilzed preparation according to  claim 5  containing between about 2.0% and 4.0% (area percent of bendamustine) of bendamustine degradants. 
     
     
         7 . A method of treating cancer in a patient comprising administering to the patient a lyophilized preparation of bendamustine or bendamustine hydrochloride according to  claim 1 . 
     
     
         8 . The method according to  claim 7 , wherein the cancer is chronic lymphocytic leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or breast cancer. 
     
     
         9 . The method according to  claim 7 , wherein the cancer is chronic lymphocytic leukemia. 
     
     
         10 . The method according to  claim 7 , wherein the cancer is non-Hodgkin's lymphoma.