Novel Solid Forms Of Bendamustine Hydrochloride

Abstract

Novel solid forms of bendamustine hydrochloride are described, as well as methods of their preparation and use.

What is claimed: 
     
         1 . A crystalline form of bendamustine hydrochloride that is Form 3 that produces an X-ray powder diffraction pattern having a peak at 26.1±0.2 degrees 2θ. 
     
     
         2 . The crystalline form of  claim 1 , wherein the X-ray powder diffraction pattern further comprises a peak selected from the group consisting of 7.9, 10.6, 15.5, 21.3, 22.1, and 23.3±0.2 degrees 2θ. 
     
     
         3 . A composition comprising at least one pharmaceutically acceptable excipient and a crystalline form of bendamustine hydrochloride that is Form 3, wherein the composition produces an X-ray powder diffraction pattern having a peak at 26.1±0.2 degrees 2θ. 
     
     
         4 . The composition of  claim 3 , wherein the X-ray powder diffraction pattern further comprises a peak selected from the group consisting of 7.9, 10.6, 15.5, 21.3, 22.1, and 23.3±0.2 degrees 2θ. 
     
     
         5 . The composition of  claim 3 , wherein the excipient is sodium phosphate, potassium phosphate, citric acid, tartaric acid, gelatin, glycine, mannitol, lactose, sucrose, maltose, glycerin, dextrose, dextran, trehalose, hetastarch, or a mixture thereof. 
     
     
         6 . The composition of  claim 3 , wherein the excipient is mannitol. 
     
     
         7 . The composition of  claim 3 , further comprising bendamustine hydrochloride monohydrate. 
     
     
         8 . The composition of  claim 3 , further comprising amorphous bendamustine hydrochloride. 
     
     
         9 . The composition of  claim 3 , further comprising bendamustine hydrochloride monohydrate and amorphous bendamustine hydrochloride. 
     
     
         10 . A method of treating chronic lymphocytic leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or breast cancer in a patient in need thereof comprising administering to the patient a composition according to  claim 3 . 
     
     
         11 . The method according to  claim 10 , wherein the non-Hodgkin's lymphoma is indolent B-cell non-Hodgkin's lymphoma. 
     
     
         12 . The method according to  claim 10 , comprising administering the composition as a reconstituted injectable preparation.