IP Library › Patent Application 16695624
Patent Application
App. No. 16/695,624

BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS

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Quick Facts
Patent No.
US None
App. No.
16/695,624
Abstract

The present invention provides pharmaceutical formulations of lyophilized bendamustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized bendamustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.

Claims (14)

1 . A pharmaceutical composition comprising bendamustine or bendamustine hydrochloride, at least one excipient, and containing not more than about 0.9% (area percent of bendamustine) of HP1:

wherein the pharmaceutical composition is a lyophilized composition.

2 . The pharmaceutical composition of claim 1 containing not more than about 0.5% (area percent of bendamustine) of HP1.

3 . The pharmaceutical composition of claim 1 containing not more than about 0.4% (area percent of bendamustine) of HP1.

4 . The pharmaceutical composition of claim 1 containing not more than about 0.5% (area percent of bendamustine) of a compound of Formula IV:

5 . The pharmaceutical composition of claim 1 containing less than or equal to about 4.0% (area percent of bendamustine) of bendamustine degradants.

6 . The pharmaceutical composition of claim 5 containing between about 2.0% and 4.0% (area percent of bendamustine) of bendamustine degradants.

7 . The pharmaceutical composition of claim 1 containing from about 10 mg to about 300 mg of bendamustine or bendamustine hydrochloride.

8 . The pharmaceutical composition of claim 1 containing about 25 mg of bendamustine or bendamustine hydrochloride.

9 . The pharmaceutical composition of claim 1 containing about 100 mg of bendamustine or bendamustine hydrochloride.

10 . A method of treating cancer in a patient comprising administering to the patient the pharmaceutical composition of bendamustine or bendamustine hydrochloride according to claim 1 .

11 . The method according to claim 10 , wherein the cancer is chronic lymphocytic leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or breast cancer.

12 . The method according to claim 10 , wherein the cancer is chronic lymphocytic leukemia.

13 . The method according to claim 10 , wherein the cancer is non-Hodgkin's lymphoma.

Assignments (1)
CHANGE OF NAME Recorded Jul 26, 2022
From: CEPHALON, INC.
To: CEPHALON LLC
Reel/Frame 060921/0078 →