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|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 stable lyophilized preparation comprising bendamustine hydrochloride, mannitol, and a trace amount of tertiary-butyl alcohol (TBA), wherein the ratio by weight of
bendamustine hydrochloride to mannitol is 15:25.5.
2. The stable lyophilized preparation of claim 1 in a vial containing 25 mg bendamustine hydrochloride.
3. The stable lyophilized preparation of claim 1 in a vial containing 100 mg bendamustine hydrochloride.
4. A stable lyophilized preparation comprising bendamustine hydrochloride and mannitol in a ratio by weight of about 15:25.5, wherein the preparation is obtained by a process comprising: a) preparing a composition comprising bendamustine hydrochloride, mannitol, tertiary-butyl alcohol and water, wherein the bendamustine hydrochloride and mannitol are present in the ratio by weight of about 15:25.5, and b) lyophilizing the composition from step a) to obtain the preparation.