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Claims for Patent: 8,669,279

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Claims for Patent: 8,669,279

Title:Solid forms of bendamustine hydrochloride
Abstract: Novel solid forms of bendamustine hydrochloride are described, as well as methods of their preparation and use.
Inventor(s): Cooper; Martin Ian (Foxton, GB), Courvoisier; Laurent D. (Thorndale, PA), Eddleston; Mark (Chillwell, GB), McKean; Robert E. (Chester Springs, PA)
Assignee: Cephalon, Inc. (Frazer, PA)
Application Number:13/874,575
Patent Claims: 1. A crystalline form of bendamustine hydrochloride that is bendamustine hydrochloride Form 3, that produces an X-ray powder diffraction pattern comprising the following reflections: 7.9, 15.5, and 26.1.+-.0.2 degrees 2.theta..

2. The bendamustine hydrochloride according to claim 1 that produces an X-ray powder diffraction pattern further comprising one or more of the following reflections: 10.6, 19.7 and/or 23.3.+-.0.2 degrees 2.theta..

3. The bendamustine hydrochloride according to claim 1 that is substantially free of other crystalline forms of bendamustine hydrochloride.

4. A composition comprising the crystalline form of bendamustine hydrochloride according to claim 1.

5. The composition according to claim 4, further comprising at least one pharmaceutically acceptable excipient.

6. The composition according to claim 4, wherein the composition is substantially free of other crystalline forms of bendamustine hydrochloride.

7. The composition according to claim 5, wherein the composition is substantially free of other crystalline forms of bendamustine hydrochloride.

8. The composition according to claim 4, wherein the composition further comprises amorphous bendamustine hydrochloride.

9. The composition according to claim 5, wherein the composition further comprises amorphous bendamustine hydrochloride.

10. The composition according claim 4, wherein the pharmaceutically acceptable excipient is sodium phosphate, potassium phosphate, citric acid, tartaric acid, gelatin, glycine, mannitol, lactose, sucrose, maltose, glycerin, dextrose, dextran, trehalose, hetastarch, or a mixture thereof.

11. The composition according to claim 10 wherein the excipient is mannitol.

12. The composition according to claim 4 wherein the composition is a pharmaceutical composition.

13. A lyophilized composition comprising the crystalline form of bendamustine hydrochloride according to claim 1, at least one pharmaceutically acceptable excipient, and an organic solvent.

14. The lyophilized composition of claim 13, wherein the lyophilized composition further comprises amorphous bendamustine hydrochloride.

15. The lyophilized composition of claim 13, wherein the lyophilized composition is substantially free of other crystalline forms of bendamustine hydrochloride.

16. The lyophilized composition of claim 13, wherein the pharmaceutically acceptable excipient is sodium phosphate, potassium phosphate, citric acid, tartaric acid, gelatin, glycine, mannitol, lactose, sucrose, maltose, glycerin, dextrose, dextran, trehalose, hetastarch, or a mixture thereof.

17. The lyophilized composition of claim 16, wherein the excipient is mannitol.

18. The lyophilized composition of claim 13, wherein the organic solvent is methanol, ethanol, n-propanol, iso-propanol, n-butanol, tert-butanol, or mixtures thereof.

19. The lyophilized composition of claim 18, wherein the organic solvent is tert-butanol.

20. The lyophilized composition of claim 19, further comprising amorphous bendamustine hydrochloride and mannitol.

21. A method of treating chronic lymphocytic leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma or breast cancer in a patient in need thereof comprising administering to the patient a composition comprising the crystalline form of bendamustine hydrochloride according to claim 1.

22. The method according to claim 21, wherein the non-Hodgkin's lymphoma is indolent B-cell non-Hodgkin's lymphoma.
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