|Title:||Bendamustine pharmaceutical compositions|
|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.|
|Inventor(s):||Brittain; Jason Edward (El Cajon, CA), Franklin; Joe Craig (Tulsa, OK)|
|Assignee:||Cephalon, Inc. (Frazer, PA)|
1. A vial containing a reconstituted solution of bendamustine hydrochloride and mannitol in sterile water for injection, wherein the ratio by weight of bendamustine
hydrochloride to mannitol in the vial is 15:25.5, and wherein the bendamustine hydrochloride is present in the vial at a concentration of 100 mg per 20 mL.
2. The vial of claim 1, wherein the vial contains 25 mg of bendamustine hydrochloride.
3. The vial of claim 1, wherein the vial contains 100 mg of bendamustine hydrochloride.
4. A 20 mL vial containing 100 mg of bendamustine hydrochloride and 170 mg of mannitol reconstituted in sterile water for injection.