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Last Updated: September 21, 2021

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Claims for Patent: 9,533,955


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Summary for Patent: 9,533,955
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:15/045,523
Patent Claims: 1. A crystalline form of bendamustine hydrochloride that is Form 3 that produces an X-ray powder diffraction pattern having peaks at 7.9 and 15.5.+-.0.2 degrees 2.theta..

2. The crystalline form of claim 1, wherein the X-ray powder diffraction pattern further comprises a peak selected from the group consisting of 10.6, 21.3, 22.1, 23.3 and 26.1.+-.0.2 degrees 2.theta..

3. A composition comprising at least one pharmaceutically acceptable excipient and a crystalline form of bendamustine hydrochloride that is Form 3, wherein the composition produces an X-ray powder diffraction pattern having peaks at 7.9 and 15.5.+-.0.2 degrees 2.theta..

4. The composition of claim 3, wherein the X-ray powder diffraction pattern further comprises a peak selected from the group consisting of 10.6, 21.3, 22.1, 23.3 and 26.1.+-.0.2 degrees 2.theta..

5. The composition of claim 3, 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.

6. The composition of claim 3, wherein the excipient is mannitol.

7. The composition of claim 3, further comprising bendamustine hydrochloride monohydrate.

8. The composition of claim 3, further comprising amorphous bendamustine hydrochloride.

9. The composition of claim 3, further comprising bendamustine hydrochloride monohydrate and amorphous bendamustine hydrochloride.

10. 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 according to claim 3.

11. The method according to claim 10, wherein the non-Hodgkin's lymphoma is indolent B-cell non-Hodgkin's lymphoma.

12. The method according to claim 10, comprising administering the composition as a reconstituted injectable preparation.

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