.

Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Find suppliers and generic API sources
  • Predict branded drug patent expiration

► See Plans & Pricing

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

Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Citi
Deloitte
McKinsey
Daiichi Sankyo
Julphar
Healthtrust
Mallinckrodt
Teva
Moodys

Generated: July 21, 2017

DrugPatentWatch Database Preview

Claims for Patent: 8,809,394

« Back to Dashboard

Claims for Patent: 8,809,394

Title:Tranexamic acid formulations
Abstract: Disclosed are modified release oral tranexamic acid formulations and methods of treatment therewith.
Inventor(s): Moore; Keith A. (Loveland, OH), Heasley; Ralph A. (Webster Grove, MO), Greiwe; Jeffrey S. (Ft. Thomas, KY), Facemire; John W. (Douglasville, GA), Modest; Jason D. (Minneapolis, MN)
Assignee: Ferring B.V. (Hoofddorp, NL)
Application Number:13/544,685
Patent Claims: 1. A tranexamic acid tablet formulation comprising: tranexamic acid or a pharmaceutically acceptable salt thereof; and a modified release material; wherein the tranexamic acid or pharmaceutically acceptable salt thereof is present in an amount from about 50% to about 95% by weight of the formulation; wherein the modified release material is present in an amount from about 5% to about 50% by weight of the formulation; and wherein said formulation provides an in-vitro dissolution release rate of the tranexamic acid or pharmaceutically acceptable salt thereof, when measured by a USP 27 Apparatus Type II Paddle Method @ 50 RPM in 900 ml water at 37.+-.0.5.degree. C., of less than about 70% by weight of the tranexamic acid or pharmaceutically acceptable salt thereof released at about 45 minutes and not less than about 50% by weight of the tranexamic acid or pharmaceutically acceptable salt thereof released at about 90 minutes.

2. The tranexamic acid tablet formulation of claim 1, wherein the tranexamic acid or pharmaceutically acceptable salt thereof is tranexamic acid.

3. The tranexamic acid tablet formulation of claim 1, wherein formulation provides a dose of about 650 mg of tranexamic acid per tablet.

4. The tranexamic acid tablet formulation of claim 3, wherein the tranexamic acid or pharmaceutically acceptable salt thereof is tranexamic acid.

5. The tranexamic acid tablet formulation of claim 1, wherein the modified release material comprises hydroxypropylmethylcellulose.

6. The tranexamic acid tablet formulation of claim 5, wherein formulation provides a dose of about 650 mg of tranexamic acid per tablet.

7. The tranexamic acid tablet formulation of claim 6, wherein the tranexamic acid or pharmaceutically acceptable salt thereof is tranexamic acid.

8. The tranexamic acid tablet formulation of claim 1, wherein the formulation is in the form of a matrix tablet which comprises a drug mixed together with a granulated modified release material.

9. The tranexamic acid tablet formulation of claim 8, wherein the formulation provides a dose of about 650 mg of tranexamic acid per tablet.

10. The tranexamic acid tablet formulation of claim 9, wherein the tranexamic acid or pharmaceutically acceptable salt thereof is tranexamic acid.

11. The tranexamic acid tablet formulation of claim 1, wherein the tranexamic acid or pharmaceutically acceptable salt thereof is present in an amount from about 60% to about 90% by weight of the formulation.

12. The tranexamic acid tablet formulation of claim 1, wherein the tranexamic acid or pharmaceutically acceptable salt thereof is present in an amount from about 60% to about 80% by weight of the formulation.

13. The tranexamic acid tablet formulation of claim 1, wherein the modified release material is present in an amount from about 10% to about 35% by weight of the formulation.

14. The tranexamic acid tablet formulation of claim 1, wherein: the tranexamic acid or pharmaceutically acceptable salt thereof is present in an amount from about 60% to about 90% by weight of the formulation; the formulation is in the form of a matrix tablet which comprises a granulated drug mixed together with the modified release material and the formulation provides a dose of about 650 mg of tranexamic acid per tablet.

15. The tranexamic acid tablet formulation of claim 14, wherein the tranexamic acid or pharmaceutically acceptable salt thereof is tranexamic acid.

16. The tranexamic acid tablet formulation of claim 14, wherein the modified release material comprises hydroxypropylmethylcellulose.

17. The tranexamic acid tablet formulation of claim 16, wherein the tranexamic acid or pharmaceutically acceptable salt thereof is tranexamic acid.

18. An oral dosage form comprising a tranexamic acid tablet formulation according to claim 1 coated with a film.

19. The oral dosage form of claim 18, wherein the film comprises a film-forming agent present in an amount in the range from about 2% tablet weight to about 4% tablet weight.

20. The oral dosage form of claim 18, wherein the film comprises a film-forming agent forming agent that comprises a (diethylaminoethyl)methacrylate/methyl-butyl-methacrylate copolymer.

21. The oral dosage form of claim 20, wherein the film forming agent comprises Eudragit E.

22. The oral dosage form of claim 18, wherein the tranexamic acid or pharmaceutically acceptable salt thereof is tranexamic acid.

23. The oral dosage form of claim 18, wherein the formulation provides a dose of about 650 mg of tranexamic acid per tablet.

24. The oral dosage form of claim 23, wherein the tranexamic acid or pharmaceutically acceptable salt thereof is tranexamic acid.

25. The oral dosage form of claim 18, wherein the modified release material comprises hydroxypropylmethylcellulose.

26. The oral dosage form of claim 25, wherein the formulation provides a dose of about 650 mg of tranexamic acid per tablet.

27. The oral dosage form of claim 26, wherein the tranexamic acid or pharmaceutically acceptable salt thereof is tranexamic acid.

28. The oral dosage form of claim 18, wherein the formulation is in the form of a matrix tablet which comprises a drug mixed together with a granulated modified release material.

29. The oral dosage form of claim 28, wherein the formulation provides a dose of about 650 mg of tranexamic acid per tablet.

30. The oral dosage form of claim 29, wherein the tranexamic acid or pharmaceutically acceptable salt thereof is tranexamic acid.

31. The oral dosage form of claim 18, wherein the tranexamic acid or pharmaceutically acceptable salt thereof is present in an amount from about 60% to about 90% by weight of the formulation.

32. The oral dosage form of claim 18, wherein the tranexamic acid or pharmaceutically acceptable salt thereof is present in an amount from about 60% to about 80% by weight of the formulation.

33. The oral dosage form of claim 18, wherein the modified release material is present in an amount from about 10% to about 35% by weight of the formulation.

34. The oral dosage form of claim 18, wherein: the tranexamic acid or pharmaceutically acceptable salt thereof is present in an amount from about 60% to about 90% by weight of the formulation; the formulation is in the form of a matrix tablet which comprises a granulated drug mixed together with the modified release material and the formulation provides a dose of about 650 mg of tranexamic acid per tablet.

35. The oral dosage form of claim 34, wherein the tranexamic acid or pharmaceutically acceptable salt thereof is tranexamic acid.

36. The oral dosage form of claim 34, wherein the modified release material comprises hydroxypropylmethylcellulose.

37. The oral dosage form of claim 36, wherein the tranexamic acid or pharmaceutically acceptable salt thereof is tranexamic acid.

38. A method of treating menorrhagia comprising administering to a patient in need of such treatment at least one tablet of the tranexamic acid formulation of claim 1, wherein the formulation provides a dose of about 650 mg of tranexamic acid per tablet.

39. A method of treating menorrhagia comprising administering to a patient in need of such treatment at least one tablet of the tranexamic acid formulation of claim 18, wherein the formulation provides a dose of about 650 mg of tranexamic acid per tablet.

40. The method of claim 38 wherein: the tranexamic acid or pharmaceutically acceptable salt thereof is present in an amount from about 60% to about 90% by weight of the formulation; and the modified release material is present in an amount from about 10% to about 35% by weight of the formulation.

41. The method of claim 39, wherein: the tranexamic acid or pharmaceutically acceptable salt thereof is present in an amount from about 60% to about 90% by weight of the formulation; and the modified release material is present in an amount from about 10% to about 35% by weight of the formulation.
« Back to Dashboard

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

Serving 500+ biopharmaceutical companies globally:

Queensland Health
Fuji
Medtronic
Federal Trade Commission
Healthtrust
US Department of Justice
Farmers Insurance
Baxter
Julphar
Chinese Patent Office

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot