.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Claims for Patent: 8,883,836

« Back to Dashboard

Claims for Patent: 8,883,836

Title:Solid forms of bendamustine hydrochloride
Abstract: Novel solid forms of bendamustine hydrochloride are described, as well as methods of their preparation and use.
Inventor(s): Cooper; Martin Ian (Cambridge, GB), Courvoisier; Laurent D. (Thorndale, PA), Eddleston; Mark (Nottingham, GB), McKean; Robert E. (Chester Springs, PA)
Assignee: Cephalon, Inc. (Frazer, PA)
Application Number:14/200,738
Patent Claims: 1. A method of treating chronic lymphocytic leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or breast cancer in a patient in need thereof comprising administering to the patient a solution prepared from a lyophilized composition comprising a crystalline form of bendamustine hydrochloride that is bendamustine hydrochloride Form 3 that produces an X-ray powder diffraction pattern comprising the following reflections: 7.9, 15.5, and 26.1.+-.0.2 degrees 2.theta..

2. The method according to claim 1, wherein the non-Hodgkin's lymphoma is indolent B-cell non-Hodgkin's lymphoma.

3. The method of according to claim 1, for treating chronic lymphocytic leukemia.

4. The method according to claim 1, wherein the bendamustine hydrochloride Form 3 produces an X-ray powder diffraction pattern further comprising one or more of the following reflections: 10.6, 19.7 and/or 23.3.+-.0.2 degrees 2.theta..

5. The method according to claim 1, wherein the lyophilized composition is substantially free of other crystalline forms of bendamustine hydrochloride.

6. The method according to claim 1, wherein the lyophilized composition further comprises amorphous bendamustine hydrochloride.

7. The method according to claim 1, wherein the lyophilized composition further comprises at least one pharmaceutically acceptable excipient.

8. The method according to claim 7, wherein the excipient is sodium phosphate, potassium phosphate, citric acid, tartaric acid, gelatin, glycine, mannitol, lactose, sucrose, maltose, glycerin, dextrose, dextran, trehalose, hetastarch, or a mixture thereof.

9. The method according to claim 8, wherein the excipient is mannitol.

10. The method according to claim 1, wherein the lyophilized composition further comprises an organic solvent.

11. The method according to claim 10, wherein the solvent is methanol, ethanol, n-propanol, iso-propanol, n-butanol, tert-butanol, or mixtures thereof.

12. The method according to claim 11, wherein the solvent is tert-butanol.

13. A method for preparing a crystalline form of bendamustine hydrochloride that is bendamustine hydrochloride Form 3 that produces an X-ray powder diffraction pattern comprising the following reflections: 7.9, 15.5, and 26.1.+-.0.2 degrees 2.theta. comprising combining bendamustine hydrochloride, mannitol, water, and an organic solvent to form a solution; and lyophilizing the solution to form the bendamustine hydrochloride Form 3.

14. The method according to claim 13, wherein the bendamustine hydrochloride Form 3 produces an X-ray powder diffraction pattern further comprising one or more of the following reflections: 10.6, 19.7 and/or 23.3.+-.0.2 degrees 2.theta..

15. The method according to claim 13, wherein the solvent is methanol, ethanol, n-propanol, iso-propanol, n-butanol, tert-butanol, or mixtures thereof.

16. The method according to claim 13, wherein the solvent is tert-butanol.

17. The method according to claim 13, wherein the lyophilization step comprises the following lyophilization cycle: TABLE-US-00019 Process parameters Target Setpoint Loading temperature 5.degree. C. Freezing temperature Hold at -50.degree. C. for 4 hours Primary drying vacuum 150 microns Primary drying temperature Hold at -15.degree. C. for 27 hours Intermediate drying temperature Hold at -12.degree. C. for 7 hours Secondary drying vacuum 50 microns Secondary drying temperature Hold at 40.degree. C. for 15 hours.

18. The method according to claim 13, wherein the ratio of bendamustine hydrochloride to mannitol is 15:25.5.

19. A lyophilized composition comprising bendamustine hydrochloride prepared according to the method of claim 13.

20. A method of treating chronic lymphocytic leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma or breast cancer in a patient in need thereof comprising administering to the patient an injectable preparation prepared from the lyophilized composition of claim 19.

21. The method according to claim 20, wherein the non-Hodgkin's lymphoma is indolent B-cell non-Hodgkin's lymphoma.

22. The method of according to claim 20, for treating chronic lymphocytic leukemia.
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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.

`abc