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Claims for Patent: 9,144,568

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Claims for Patent: 9,144,568

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:14/714,578
Patent Claims: 1. A method of treating chronic lymphocytic leukemia or indolent B cell non-Hodgkin's lymphoma comprising parenterally administering to a subject a volume of about 100 ml or less of a liquid composition comprising: a) from about 0.5 to about 5.6 mg/ml of bendamustine or a pharmaceutically acceptable salt thereof; b) a solubilizer comprising polyethylene glycol and propylene glycol, wherein the amount of solubilizer is from about 0.5 to about 26.5% vol; c) a parenterally acceptable diluent; and optionally d) an antioxidant; over a period of less than or equal to about 15 minutes to the subject.

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

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

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

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

6. The method of claim 5, wherein the volume administered is about 50 ml.

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

8. The method of claim 1, wherein the volume administered is about 50 ml.

9. The method of claim 1, wherein the bendamustine is administered to treat chronic lymphocytic leukemia.

10. The method of claim 9, wherein the composition is administered intravenously in a volume of about 50 ml in 10 minutes or less on days 1 and 2 of a 28 day cycle.

11. The method of claim 10, wherein the composition is administered in about 10 minutes.

12. The method of claim 10, wherein the composition is administered for up to 6 cycles.

13. The method of claim 9, 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.

14. The method of claim 13, wherein the composition provides a bendamustine dosage of about 100 mg/m.sup.2.

15. The method of claim 9, wherein the liquid composition comprises from about 1.85 mg/ml to about 4.84 mg/ml of bendamustine or a pharmaceutically acceptable salt thereof.

16. The method of claim 1, wherein the bendamustine is administered to treat indolent B cell non-Hodgkin's lymphoma.

17. The method of claim 16, wherein the composition is administered intravenously in a volume of about 50 ml in about 10 minutes or less on days 1 and 2 of as 21 day cycle.

18. The method of claim 17, wherein the composition is administered in about 10 minutes.

19. The method of claim 17, wherein the composition is administered for up to 8 cycles.

20. The method of claim 16, 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.

21. The method of claim 20, wherein the composition provides a bendamustine dosage of about 120 mg/m.sup.2.

22. The method of claim 16, wherein the liquid composition comprises from about 2.19 mg/ml to about 5.59 mg/ml of bendamustine or a pharmaceutically acceptable salt thereof.

23. The method according to claim 1, wherein the bendamustine is present as the hydrochloride salt.
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