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Last Updated: April 5, 2025

Claims for Patent: 8,883,836

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Summary for Patent: 8,883,836

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 (Cambridge, GB), Courvoisier; Laurent D. (Thorndale, PA), Eddleston; Mark (Nottingham, GB), McKean; Robert E. (Chester Springs, PA)
Assignee:	Cephalon, Inc. (Frazer, PA)
Application Number:	14/200,738
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,883,836
Patent Claims:	1. 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 solution prepared from a lyophilized composition comprising 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 method according to claim 1, wherein the non-Hodgkin's lymphoma is indolent B-cell non-Hodgkin's lymphoma. 3. The method of according to claim 1, for treating chronic lymphocytic leukemia. 4. The method according to claim 1, wherein the bendamustine hydrochloride Form 3 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.. 5. The method according to claim 1, wherein the lyophilized composition is substantially free of other crystalline forms of bendamustine hydrochloride. 6. The method according to claim 1, wherein the lyophilized composition further comprises amorphous bendamustine hydrochloride. 7. The method according to claim 1, wherein the lyophilized composition further comprises at least one pharmaceutically acceptable excipient. 8. The method according to claim 7, wherein the 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. 9. The method according to claim 8, wherein the excipient is mannitol. 10. The method according to claim 1, wherein the lyophilized composition further comprises an organic solvent. 11. The method according to claim 10, wherein the solvent is methanol, ethanol, n-propanol, iso-propanol, n-butanol, tert-butanol, or mixtures thereof. 12. The method according to claim 11, wherein the solvent is tert-butanol. 13. A method for preparing 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. comprising combining bendamustine hydrochloride, mannitol, water, and an organic solvent to form a solution; and lyophilizing the solution to form the bendamustine hydrochloride Form 3. 14. The method according to claim 13, wherein the bendamustine hydrochloride Form 3 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.. 15. The method according to claim 13, wherein the solvent is methanol, ethanol, n-propanol, iso-propanol, n-butanol, tert-butanol, or mixtures thereof. 16. The method according to claim 13, wherein the solvent is tert-butanol. 17. The method according to claim 13, 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. The method according to claim 13, wherein the ratio of bendamustine hydrochloride to mannitol is 15:25.5. 19. A lyophilized composition comprising bendamustine hydrochloride prepared according to the method of claim 13. 20. 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 an injectable preparation prepared from the lyophilized composition of claim 19. 21. The method according to claim 20, wherein the non-Hodgkin's lymphoma is indolent B-cell non-Hodgkin's lymphoma. 22. The method of according to claim 20, for treating chronic lymphocytic leukemia.

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