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Claims for Patent: 8,791,270

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Claims for Patent: 8,791,270

Title:Bendamustine pharmaceutical compositions
Abstract: The present invention provides pharmaceutical formulations of lyophilized bendamustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized bendamustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.
Inventor(s): Brittain; Jason Edward (El Cajon, CA), Franklin; Joe Craig (Tulsa, OK)
Assignee: Cephalon, Inc. (Frazer, PA)
Application Number:13/969,724
Patent Claims: 1. A pharmaceutical composition that has been reconstituted from a lyophilized preparation of bendamustine or bendamustine hydrochloride, said composition containing not more than about 0.9% (area percent of bendamustine) of HP1: ##STR00008##

2. The pharmaceutical composition of claim 1, wherein the amount of HP1 is measured at time zero after reconstitution of said lyophilized preparation.

3. The pharmaceutical composition of claim 1, wherein the amount of HP1 is not more than 0.5% (area percent of bendamustine).

4. The pharmaceutical composition of claim 2, wherein the amount of HP1 is not more than 0.5% (area percent of bendamustine).

5. The pharmaceutical composition of claim 1, wherein the amount of HP1 is not more than 0.4% (area percent of bendamustine).

6. The pharmaceutical composition of claim 2, wherein the amount of HP1 is not more than 0.4% (area percent of bendamustine).

7. A pharmaceutical composition of bendamustine hydrochloride, containing less than or equal to 4.0% (area percent of bendamustine) of bendamustine degradants.

8. The pharmaceutical composition of claim 7, containing between about 2.0% and 4.0% (area percent of bendamustine) of bendamustine degradants.

9. The pharmaceutical composition of claim 8, wherein the pharmaceutical composition has been reconstituted from a lyophilized preparation of bendamustine hydrochloride.

10. The pharmaceutical composition of claim 9, containing not more than about 0.9% (area percent of bendamustine) of HP1 at time zero after reconstitution.

11. The pharmaceutical composition of claim 9, containing not more than about 0.5% (area percent of bendamustine) of HP1 at time zero after reconstitution.

12. The pharmaceutical composition of claim 9, containing not more than about 0.4% (area percent of bendamustine) of HP1 at time zero after reconstitution.

13. The pharmaceutical composition of claim 10, containing not more than about 0.5% (area percent of bendamustine) of a compound of Formula IV at time zero after reconstitution: ##STR00009##

14. The pharmaceutical composition of claim 7, wherein the pharmaceutical composition is a lyophilized composition.

15. The pharmaceutical composition of claim 8, wherein the pharmaceutical composition is a lyophilized composition.

16. The pharmaceutical composition of claim 7, containing not more than about 0.9% (area percent of bendamustine) of HP1.

17. The pharmaceutical composition of claim 7, containing not more than about 0.5% (area percent of bendamustine) of HP1.

18. The pharmaceutical composition of claim 7, containing not more than about 0.4% (area percent of bendamustine) of HP1.

19. The pharmaceutical composition of claim 7, containing not more than about 0.5% (area percent of bendamustine) of a compound of Formula IV: ##STR00010##

20. A method of treating cancer in a patient comprising administering to the patient a pharmaceutical composition of bendamustine hydrochloride according to claim 7.

21. The method according to claim 20, wherein the cancer is chronic lymphocytic leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or breast cancer.

22. The method according to claim 20, wherein the cancer is chronic lymphocytic leukemia.

23. The method according to claim 20, wherein the cancer is non-Hodgkin's lymphoma.
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