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Claims for Patent: 9,034,908

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Claims for Patent: 9,034,908

Title:Formulations of bendamustine
Abstract: Methods of treatment using bendamustine formulations designed for small volume intravenous administration are disclosed. The methods conveniently allow shorter administration time without the active ingredient coming out of solution as compared to presently available formulations.
Inventor(s): Sundaram; Srikanth (Somerset, NJ)
Assignee: EAGLE PHARMACEUTICALS, INC. (Woodcliff Lake, NJ)
Application Number:13/838,090
Patent Claims: 1. A method of treating cancer or malignant disease in a subject, comprising parenterally administering a volume of about 100 ml or less of a liquid composition comprising: a) from about 0.05 to about 12.5 mg/ml of bendamustine or a pharmaceutically acceptable salt thereof; b) a solubilizer comprising polyethylene glycol and propylene glycol, the polyethylene glycol being present in an amount of from about 0.3 to about 45% by volume and the propylene glycol being present in an amount of from about 0.03 to about 5% by volume; c) a parenterally acceptable diluent; and optionally d) an antioxidant; over a period of less than or equal to about 10 minutes to the subject.

2. The method of claim 1, wherein the subject is human.

3. The method of claim 1, wherein the concentration of the bendamustine or pharmaceutically acceptable salt is from about 0.1 to about 6.0 mg/ml.

4. The method of claim 1, wherein the concentration of the bendamustine or pharmaceutically acceptable salt is from about 0.05 to about 3.2 mg/ml.

5. The method of claim 1, wherein the concentration of the bendamustine or pharmaceutically acceptable salt is from about 0.5 to about 5.6 mg/ml.

6. The method of claim 1, wherein the amount of solubilizer is from about 0.5 to about 26.5% vol.

7. The method of claim 1, wherein the amount of solubilizer is from about 0.2 to about 5% vol.

8. The method of claim 1, wherein the amount of solubilizer is from about 2.0 to about 22.4% vol.

9. The method of claim 1, where the polyethylene glycol is PEG 400.

10. The method of claim 1, wherein the weight ratio of polyethylene glycol to propylene glycol is about 90:10.

11. The method of claim 5, wherein the weight ratio of polyethylene glycol to propylene glycol is about 85:15.

12. The method of claim 1, wherein the volume administered is about 50, 30 or 15 ml.

13. The method of claim 1, wherein the antioxidant is monothioglycerol.

14. The method of claim 10, wherein the volume administered is about 50 ml or less.

15. The method of claim 1, wherein the cancer or malignant disease is chronic lymphocytic leukemia.

16. The method of claim 14, wherein the composition is administered intravenously in less than about 10 minutes on days 1 and 2 of a 28 day cycle.

17. The method of claim 14, wherein the composition is administered intravenously in less than about 10 minutes on days 1 and 2 of a 28 day cycle.

18. The method of claim 1, wherein the composition is administered for up to 6 cycles.

19. The method of claim 14, wherein the volume of the composition administered to the subject provides a bendamustine dosage amount ranging from about 25 mg/m.sup.2 to about 100 mg/m.sup.2 to the subject.

20. The method of claim 1, wherein the cancer or malignant disease is indolent B cell non-Hodgkin's lymphoma.

21. The method of claim 15, wherein the composition is administered intravenously in less than 10 minutes on days 1 and 2 of a 21 day cycle.

22. The method of claim 16, wherein the composition is administered for up to 8 cycles.

23. The method of claim 15, wherein the volume of the composition administered to the subject provides a bendamustine dosage amount ranging from about 60 mg/m.sup.2 to about 120 mg/m.sup.2 to the subject.

24. A method according to claim 1, wherein the bendamustine is present as the hydrochloride salt.
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