US2013041004A1PendingUtilityA1

Liquid Formulations Of Bendamustine

67
Individually held — no corporate assignee on recordPriority: Sep 25, 2008Filed: Oct 19, 2012Published: Feb 14, 2013
Est. expirySep 25, 2028(~2.2 yrs left)· nominal 20-yr term from priority
Inventors:Anthony S. DragerRachel Y. LabellPiyush R. Patel
A61K 47/18A61K 47/20A61K 9/0019A61K 47/22A61P 35/02A61K 47/10A61K 9/08A61K 31/4184A61P 35/00A61K 47/40
67
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Claims

Abstract

Stable liquid formulations of bendamustine, and pharmaceutically acceptable salts thereof, and polar aprotic solvents, are described.

Claims

exact text as granted — not AI-modified
1 . A stable, liquid, pharmaceutical formulation comprising bendamustine, or a pharmaceutically acceptable salt thereof, and a polar aprotic solvent, wherein said formulation is suitable for injection into a patient following dilution with a pharmaceutically acceptable diluent. 
     
     
         2 . The formulation of  claim 1 , wherein the polar aprotic solvent is 1-methyl-2-pyrrolidone, 1,3-dimethyl-2-imidazolidinone, dimethylacetamide, dimethyl sulfoxide, acetone, tetrahydrofuran, 1,4-dioxane, acetonitrile, dimethyl formamide, propylene carbonate, or a mixture thereof. 
     
     
         3 . The formulation of  claim 2 , wherein the polar aprotic solvent is dimethylacetamide. 
     
     
         4 . The formulation of  claim 1 , further comprising a non-aqueous polar protic solvent. 
     
     
         5 . The formulation of  claim 4 , comprising between about 30% and about 70%, by volume of the formulation, of the nonaqueous polar protic solvent. 
     
     
         6 . The formulation of  claim 4 , wherein the non-aqueous polar protic solvent is an alcohol, a polyalkylene glycol, an amide, or a mixture thereof. 
     
     
         7 . The formulation of  claim 4 , wherein the non-aqueous polar protic solvent is an alcohol. 
     
     
         8 . The formulation of  claim 7 , wherein the alcohol is a cyclodextrin. 
     
     
         9 . The formulation of  claim 4 , wherein the non-aqueous polar protic solvent is propylene glycol. 
     
     
         10 . The formulation of  claim 4 , wherein the polar aprotic solvent is dimethylacetamide. 
     
     
         11 . The formulation of  claim 10 , wherein the nonaqueous polar protic solvent is propylene glycol. 
     
     
         12 . The formulation of  claim 11 , comprising about 66% (v/v) of the dimethylacetamide and about 34% (v/v) of the propylene glycol. 
     
     
         13 . The formulation of  claim 12 , comprising from about 5 mg/ml to about 120 mg/mL of bendamustine, or a pharmaceutically acceptable salt thereof. 
     
     
         14 . The formulation of  claim 13 , comprising about 100 mg/mL of bendamustine, or a pharmaceutically acceptable salt thereof. 
     
     
         15 . The formulation of  claim 1 , comprising from about 5 mg/ml to about 200 mg/mL of bendamustine, or a pharmaceutically acceptable salt thereof. 
     
     
         16 . The formulation of  claim 1 , comprising from about 5 mg/ml to about 120 mg/mL of bendamustine, or a pharmaceutically acceptable salt thereof. 
     
     
         17 . The formulation of  claim 1 , comprising about 100 mg/mL of bendamustine, or a pharmaceutically acceptable salt thereof. 
     
     
         18 . The formulation of  claim 1 , wherein the bendamustine is bendamustine hydrochloride. 
     
     
         19 . The formulation of  claim 1 , further comprising at least one pharmaceutically acceptable excipient or diluent. 
     
     
         20 . The formulation of  claim 4 , further comprising at least one pharmaceutically acceptable excipient or diluent. 
     
     
         21 . The formulation of  claim 1 , further comprising an antioxidant, a surfactant, a lipid, a filler, an organic acid, a hydrophilic polymer, a complexing agent, a preservative, or a combination thereof. 
     
     
         22 . A method of treating cancer comprising
 providing a liquid, pharmaceutical formulation of  claim 1 ;   diluting the liquid pharmaceutical formulation with a pharmaceutically acceptable injectable diluent to form an injectable pharmaceutical preparation;   administering the injectable pharmaceutical preparation to a patient in need of treatment for cancer.   
     
     
         23 . The method of  claim 22 , wherein the liquid pharmaceutical formulation comprises the polar aprotic solvent dimethylacetamide. 
     
     
         24 . The method of  claim 23 , wherein the liquid pharmaceutical formulation comprises the polar aprotic solvent dimethylacetamide and further comprises the nonaqueous polar protic solvent propylene glycol 
     
     
         25 . The method of  claim 24 , wherein the liquid pharmaceutical formulation comprises about 66% (v/v) of the dimethylacetamide and about 34% (v/v) of the propylene glycol. 
     
     
         26 . The method of  claim 25 , wherein the liquid pharmaceutical formulation comprises from about 5 mg/ml to about 120 mg/mL of bendamustine, or a pharmaceutically acceptable salt thereof. 
     
     
         27 . The method of  claim 26 , wherein the liquid pharmaceutical formulation comprises about 100 mg/mL of bendamustine, or a pharmaceutically acceptable salt thereof. 
     
     
         28 . The method of  claim 22 , wherein the pharmaceutically acceptable injectable diluent is 0.9% sodium chloride. 
     
     
         29 . The method of  claim 22 , wherein the cancer is chronic lymphocytic leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or breast cancer. 
     
     
         30 . The method of  claim 29 , wherein the cancer is chronic lymphocytic leukemia or non-Hodgkin's lymphoma.

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