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Claims for Patent: 8,445,524

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Claims for Patent: 8,445,524

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): Courvoisier; Laurent D. (Thorndale, PA), McKean; Robert E. (Chester Springs, PA), Jansch; Hans-Joachim (Radebeul, DE)
Assignee: Cephalon, Inc. (Frazer, PA)
Application Number:13/301,979
Patent Claims: 1. A solid form of bendamustine hydrochloride, designated as bendamustine hydrochloride Form 1, that produces an X-ray powder diffraction pattern comprising the following reflections: 8.3, 16.8, and 18.5.+-.0.2 degrees 2.theta..

2. The solid form of bendamustine hydrochloride according to claim 1 that produces an X-ray powder diffraction pattern further comprising the following reflections: 14.0, 22.0, 22.9, 25.1, and 28.3.+-.0.2 degrees 2.theta..

3. The solid form of bendamustine hydrochloride according to claim 1 that produces an X-ray powder diffraction pattern further comprising a reflection at 14.0.+-.0.2 degrees 2.theta..

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

5. A composition comprising the solid form of bendamustine hydrochloride according to claim 1, wherein the composition is substantially free of other solid forms of bendamustine hydrochloride.

6. The composition according to claim 4 wherein the composition is a pharmaceutical composition and further comprises at least one pharmaceutically acceptable excipient.

7. The composition of claim 6 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.

8. The composition of claim 7 wherein the excipient is mannitol.

9. The composition according to claim 5 wherein the composition is a pharmaceutical composition and further comprises at least one pharmaceutically acceptable excipient.

10. The composition of claim 9 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 of claim 10 wherein the excipient is mannitol.

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

13. The method according to claim 12 wherein the non-Hodgkin's lymphoma is indolent B-cell non-Hodgkin's lymphoma.

14. A method for preparing a lyophilized composition comprising bendamustine hydrochloride comprising: combining the bendamustine hydrochloride Form 1, according to claim 1, mannitol, water, and an organic solvent to form a solution; and lyophilizing the solution to form the lyophilized composition comprising bendamustine hydrochloride.

15. The method of claim 14, wherein the solvent is methanol, n-propanol, isopropanol, n-butanol, tert-butanol, or a mixture thereof.

16. The method of claim 14, wherein the solvent is tert-butanol.

17. The method of claim 14, wherein the lyophilization step comprises the following lyophilization cycle: TABLE-US-00019 Process parameters Target Setpoint Loading temperature 5.degree. C. Freezing temperature Hold at -50.degree. C. for 4 hours Primary drying vacuum 150 microns Primary drying temperature Hold at -15.degree. C. for 27 hours Intermediate drying temperature Hold at -12.degree. C. for 7 hours Secondary drying vacuum 50 microns Secondary drying temperature Hold at 40.degree. C. for 15 hours.

18. A lyophilized composition comprising bendamustine hydrochloride prepared according to the method of any one of claims 14 to 17.

19. A method of treating chronic lymphocytic leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma or breast cancer in a patient comprising administering to the patient an injectable preparation prepared from the lyophilized composition of claim 18.
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