Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
|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.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.