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 pharmaceutical composition comprising bendamustine or bendamustine hydrochloride, at least one excipient, and containing not more than about 0.9% (area percent of bendamustine) of HP1: 
       
         
           
           
               
               
           
         
       
       wherein the pharmaceutical composition is a lyophilized composition. 
     
     
         2 . The pharmaceutical composition of  claim 1  containing not more than about 0.5% (area percent of bendamustine) of HP1. 
     
     
         3 . The pharmaceutical composition of  claim 1  containing not more than about 0.4% (area percent of bendamustine) of HP1. 
     
     
         4 . The pharmaceutical composition of  claim 1  containing not more than about 0.5% (area percent of bendamustine) of a compound of Formula IV: 
       
         
           
           
               
               
           
         
       
     
     
         5 . The pharmaceutical composition of  claim 1  containing less than or equal to about 4.0% (area percent of bendamustine) of bendamustine degradants. 
     
     
         6 . The pharmaceutical composition of  claim 5  containing between about 2.0% and 4.0% (area percent of bendamustine) of bendamustine degradants. 
     
     
         7 . The pharmaceutical composition of  claim 1  containing from about 10 mg to about 300 mg of bendamustine or bendamustine hydrochloride. 
     
     
         8 . The pharmaceutical composition of  claim 1  containing about 25 mg of bendamustine or bendamustine hydrochloride. 
     
     
         9 . The pharmaceutical composition of  claim 1  containing about 100 mg of bendamustine or bendamustine hydrochloride. 
     
     
         10 . A method of treating cancer in a patient comprising administering to the patient the pharmaceutical composition of bendamustine or bendamustine hydrochloride according to  claim 1 . 
     
     
         11 . The method according to  claim 10 , wherein the cancer is chronic lymphocytic leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or breast cancer. 
     
     
         12 . The method according to  claim 10 , wherein the cancer is chronic lymphocytic leukemia. 
     
     
         13 . The method according to  claim 10 , wherein the cancer is non-Hodgkin's lymphoma.