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Claims for Patent: 8,344,006

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Claims for Patent: 8,344,006

Title:Liquid formulations of bendamustine
Abstract: Stable liquid formulations of bendamustine, and pharmaceutically acceptable salts thereof, and polar aprotic solvents, are described.
Inventor(s): Drager; Anthony S. (Thorndale, PA), Labell; Rachel Y. (Coatesville, PA), Patel; Piyush R. (Wallingford, PA)
Assignee: Cephalon, Inc. (Frazer, PA)
Application Number:13/362,430
Patent Claims: 1. A stable, non-aqueous liquid, pharmaceutical formulation comprising from about 5 mg/ml to about 120 mg/mL of bendamustine, or a pharmaceutically acceptable salt thereof, solubilized in about 66% (v/v) of dimethylacetamide and about 34% (v/v) of propylene glycol, wherein said formulation, following dilution with a pharmaceutically acceptable diluent, is suitable for injection into a patient without lyophilization.

2. The formulation of claim 1, comprising about 100 mg/mL of bendamustine, or a pharmaceutically acceptable salt thereof.

3. The formulation of claim 1, wherein the bendamustine is bendamustine hydrochloride.

4. The formulation of claim 1, further comprising at least one pharmaceutically acceptable excipient or diluent.

5. 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.

6. A method of treating chronic lymphocytic leukemia or non-Hodgkin's lymphoma 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 thereof.

7. The method of claim 6, wherein the liquid pharmaceutical formulation comprises about 100 mg/mL of bendamustine, or a pharmaceutically acceptable salt thereof.

8. The method of claim 6, wherein the pharmaceutically acceptable injectable diluent is 0.9% sodium chloride.

9. The formulation of claim 2, comprising 90 mg/mL of bendamustine hydrochloride.

10. The method of claim 7, comprising 90 mg/mL of bendamustine hydrochloride.
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