.

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: 9,000,021

« Back to Dashboard

Claims for Patent: 9,000,021

Title:Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration
Abstract: Methods of treating bendamustine responsive conditions in patients having fluid and/or sodium intake restrictions are disclosed. The methods include identifying patients having such restrictions and in need of bendamustine, and then administering thereto a bendamustine-containing composition in a volume of about 120 ml or less intravenously over a period of about 15 minutes or less. The smaller volumes and reduced sodium load as compared to currently known methods of treatment minimize cardiac and/or renal stress in patients having diseases such as congestive heart failure or renal disease.
Inventor(s): Sundaram; Srikanth (Somerset, NJ), Tarriff; Scott L. (Mahwah, NJ)
Assignee: Eagle Pharmaceuticals, Inc. (Woodcliff Lake, NJ)
Application Number:13/838,267
Patent Claims: 1. A method of treating a bendamustine-responsive condition in a subject requiring restricted fluid and/or sodium intake, comprising a) identifying a subject in need of bendamustine therapy and having a physiological condition requiring restricted fluid and/or sodium intake; b) parenterally administering to said subject a volume of about 100 ml or less of a liquid composition containing: i) from about 0.05 to about 12.5 mg/ml of bendamustine or a pharmaceutically acceptable salt thereof; ii) a solubilizer comprising polyethylene glycol and propylene glycol, the polyethylene glycol being present in an amount of from about 0.3 to about to 45% volume and the propylene glycol being present in an amount of from about 0.03 to about 5% volume; and, optionally iii) a parenterally acceptable diluent over a substantially continuous period of less than or equal to about 30 minutes.

2. The method of claim 1, wherein the diluent comprises 0.9% NaCl or 0.45% NaCl.

3. The method of claim 1, wherein the subject has congestive heart disease.

4. The method of claim 1, wherein the subject has renal insufficiency.

5. The method of claim 4, wherein the renal insufficiency is renal failure or renal suppression.

6. The method of claim 1, wherein the concentration of the bendamustine or pharmaceutically acceptable salt is from about 0.1 to about 3.2 mg/ml.

7. The method of claim 1, wherein the concentration of the bendamustine or pharmaceutically acceptable salt is from about 0.5 to about 5.6 mg/ml.

8. The method of claim 1, wherein the amount of solubilizer is from about 0.5 to about 26.5% vol.

9. The method of claim 1, wherein the amount of solubilizer is from about 2.0 to about 22.4% vol.

10. The method of claim 1, where the polyethylene glycol is PEG 400.

11. The method of claim 1, wherein the weight ratio of polyethylene glycol to propylene glycol is about 90:10.

12. The method of claim 1, wherein the weight ratio of polyethylene glycol to propylene glycol is about 85:15.

13. The method of claim 1, wherein the volume administered is about 50, 30 or 15 ml.

14. The method of claim 1, wherein the composition further comprises monothioglycerol and NaOH.

15. The method of claim 7, wherein the volume administered is about 50 ml+/-15% or less and the composition is administered over a time period of about 10 minutes or less.

16. The method of claim 6, wherein the volume administered is about 100 ml+/-15% or less and the composition is administered over a time period of about 15 minutes or less.

17. The method of claim 1, wherein the parenterally acceptable diluent is 0.9% NaCl (normal saline).

18. The method of claim 1, wherein the bendamustine-responsive condition is chronic lymphocytic leukemia.

19. The method of claim 18, wherein the composition is administered intravenously in a volume of about 50 ml over a time period of about 10 minutes or less on days 1 and 2 of a 28 day cycle.

20. The method of claim 18, wherein the composition is administered intravenously in a volume of about 100 ml over a time period of about 15 minutes or less on days 1 and 2 of a 28 day cycle.

21. The method of claim 18, wherein the composition is administered for up to 6 cycles.

22. The method of claim 18, wherein the volume of the composition administered to the subject provides a dosage amount ranging from about 25 mg/m.sup.2 to about 100 mg/m.sup.2 to the subject.

23. The method of claim 1, wherein the bendamustine-responsive condition is indolent B-cell non-Hodgkin's lymphoma.

24. The method of claim 23, wherein the composition is administered intravenously in a volume of about 50 ml over a time period of about 10 minutes or less on days 1 and 2 of a 21 day cycle.

25. The method of claim 23, wherein the composition is administered intravenously in a volume of about 100 ml over a time period of about 15 minutes or less on days 1 and 2 of a 21 day cycle.

26. The method of claim 23, wherein the composition is administered for up to 8 cycles.

27. The method of claim 23, wherein the volume of the composition administered to the subject provides a dosage amount ranging from about 60 mg/m.sup.2 to about 120 mg/m.sup.2 to the subject.

28. A method of treating a bendamustine-responsive condition in a subject requiring restricted fluid and/or sodium intake, comprising a) identifying a subject in need of bendamustine therapy and having a physiological condition requiring restricted fluid and/or sodium intake; b) parenterally administering to said subject a volume of about 100 ml or less of a liquid composition containing: TABLE-US-00009 Ingredient Concentration Range (mg/ml) Bendamustine HCl 0.05 to 1.6 Solubilizer 1 propylene glycol 0.3 to 6.5 Solubilizer 2 PEG 400 3.3 to 65 Monothioglycerol 0.02 to 0.35 NaOH 0.0 to 0.01

and, optionally a parenterally acceptable diluent, over a substantially continuous period of less than or equal to about 30 minutes.

29. A method of treating a bendamustine-responsive condition in a subject requiring restricted fluid and/or sodium intake, comprising a) identifying a subject in need of bendamustine therapy and having a physiological condition requiring restricted fluid and/or sodium intake; b) parenterally administering to said subject a volume of about 100 ml or less of a liquid composition containing: TABLE-US-00010 Ingredient Concentration Range (mg/ml) Bendamustine HCl 1.1 to 12.5 Solubilizer 1 propylene glycol 4.5 to 51 Solubilizer 2 PEG 400 45 to 500 Monothioglycerol 0.2 to 2.5 NaOH 0.0 to 0.04

and, optionally a parenterally acceptable diluent, over a substantially continuous period of less than or equal to about 30 minutes.

30. A method according to claim 1, wherein the bendamustine is present as the hydrochloride salt.
« Back to Dashboard

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