IP Library › Patent Application 14531023
Patent Application
App. No. 14/531,023

Novel Solid Forms Of Bendamustine Hydrochloride

Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US None
App. No.
14/531,023
Abstract

Novel solid forms of bendamustine hydrochloride are described, as well as methods of their preparation and use.

Claims (12)

1 . A crystalline form of bendamustine hydrochloride that is Form 3 that produces an X-ray powder diffraction pattern having a peak at 26.1±0.2 degrees 2θ.

2 . The crystalline form of claim 1 , wherein the X-ray powder diffraction pattern further comprises a peak selected from the group consisting of 7.9, 10.6, 15.5, 21.3, 22.1, and 23.3±0.2 degrees 2θ.

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 a peak at 26.1±0.2 degrees 2θ.

4 . The composition of claim 3 , wherein the X-ray powder diffraction pattern further comprises a peak selected from the group consisting of 7.9, 10.6, 15.5, 21.3, 22.1, and 23.3±0.2 degrees 2θ.

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.