You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

Details for Patent: 8,461,350


✉ Email this page to a colleague

« Back to Dashboard


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)
Filing Date:Oct 18, 2012
Application Number:13/654,898
Claims:1. A pharmaceutical composition comprising bendamustine or bendamustine hydrochloride, mannitol, water, and a solvent that is ethanol, n-propanol, n-butanol, isopropanol, methanol, ethyl acetate, dimethyl carbonate, acetonitrile, dichloromethane, methyl ethyl ketone, methyl isobutyl ketone, acetone, 1-pentanol, methyl acetate, carbon tetrachloride, dimethyl sulfoxide, hexafluoroacetone, chlorobutanol, dimethyl sulfone, acetic acid, cyclohexane, or a combination thereof.

2. The pharmaceutical composition of claim 1, wherein the solvent is ethanol, n-propanol, n-butanol, isopropanol, methanol, 1-pentanol, or a combination thereof.

3. The pharmaceutical composition according to claim 1, wherein the bendamustine or bendamustine hydrochloride is present at a concentration of about 5 to 20 mg/ml, the mannitol is present at a concentration of about 10-30 mg/ml, and the solvent is present at a concentration of about 1-20% (v/v).

4. The pharmaceutical composition according to claim 1, wherein the bendamustine or bendamustine hydrochloride is present at a concentration of about 5 to 20 mg/ml, the mannitol is present at a concentration of about 10-30 mg/ml, and the solvent is present at a concentration of about 5-40% (v/v).

5. The pharmaceutical composition according to claim 1, wherein the bendamustine or bendamustine hydrochloride is present at a concentration of about 12 to 17 mg/ml, the mannitol is present at a concentration of about 20-30 mg/ml, and the solvent is present at a concentration of about 5-15% (v/v).

6. The pharmaceutical composition according to claim 1, wherein the bendamustine or bendamustine hydrochloride is present at a concentration of about 15 mg/ml, the mannitol is present at a concentration of about 25.5 mg/ml, and the solvent is present at a concentration of about 10% (v/v).

7. A lyophilized pharmaceutical composition made from the pharmaceutical composition according to claim 1.

8. The lyophilized pharmaceutical composition according to claim 7, wherein the bendamustine or bendamustine hydrochloride is present in the pharmaceutical composition at a concentration of about 5 to 20 mg/ml, the mannitol is present in the pharmaceutical composition at a concentration of about 10-30 mg/ml, and the solvent is present in the pharmaceutical composition at a concentration of about 1-20% (v/v).

9. The lyophilized pharmaceutical composition according to claim 7, wherein the bendamustine or bendamustine hydrochloride is present in the pharmaceutical composition at a concentration of about 5-20 mg/ml, the mannitol is present in the pharmaceutical composition at a concentration of about 10-30 mg/ml, and the solvent is present in the pharmaceutical composition at a concentration of about 5-40% (v/v).

10. The lyophilized pharmaceutical composition according to claim 7, wherein the bendamustine or bendamustine hydrochloride is present in the pharmaceutical composition at a concentration of about 12-17 mg/ml, the mannitol is present in the pharmaceutical composition at a concentration of about 20-30 mg/ml, and the solvent is present in the pharmaceutical composition at a concentration of about 5-15% (v/v).

11. The lyophilized pharmaceutical composition according to claim 7, wherein the bendamustine or bendamustine hydrochloride is present in the pharmaceutical composition at a concentration of about 15 mg/ml, the mannitol is present in the pharmaceutical composition at a concentration of about 25.5 mg/ml, and the solvent is present in the pharmaceutical composition at a concentration of about 10% (v/v).

12. The lyophilized pharmaceutical composition according to claim 7 containing not more than about 0.5% bendamustine ethylester.

13. The lyophilized pharmaceutical composition according to claim 8 containing not more than about 0.5% bendamustine ethylester.

14. The lyophilized pharmaceutical composition according to claim 9 containing not more than about 0.5% bendamustine ethylester.

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.