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Claims for Patent: 8,273,795

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Claims for Patent: 8,273,795

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:12/228,489
Patent Claims: 1. A method of treating menorrhagia, the method comprising: orally administering to a patient in need of such treatment a tranexamic acid 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; wherein the formulation is administered as two oral dosage forms, each providing a dose of about 650 mg of tranexamic acid; 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 40% by weight of the tranexamic acid or pharmaceutically acceptable salt thereof released at about 15 minutes, 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 method of claim 1, wherein said formulation provides an in-vitro dissolution release rate of the tranexamic acid or pharmaceutically acceptable salt thereof, when measured by the USP 27 Apparatus Type II Paddle Method @ 50 RPM in 900 ml water at 37.+-.0.5.degree. C., of about 0% to about 40% by weight of the tranexamic acid or pharmaceutically acceptable salt thereof released at about 15 minutes, from about 20% to about 60% by weight of the tranexamic acid or pharmaceutically acceptable salt thereof released at about 30 minutes, from about 40% to about 65% by weight of the tranexamic acid or pharmaceutically acceptable salt thereof released at about 45 minutes, from about 50% to about 95% by weight of the tranexamic acid or pharmaceutically acceptable salt thereof released at about 60 minutes, and not less than about 60% by weight of the tranexamic acid or pharmaceutically acceptable salt thereof released at about 90 minutes.

3. The method of claim 1, wherein the formulation releases about 10% to about 25% by weight of the tranexamic acid or pharmaceutically acceptable salt thereof every 15 minutes when measured in vitro utilizing the USP 27 Apparatus Type II Paddle Method @ 50 RPM in 900 ml water at 37.+-.0.5.degree. C.

4. The method of claim 1, wherein the formulation releases about 1% of the tranexamic acid or pharmaceutically acceptable salt thereof every minute when measured in-vitro utilizing the USP 27 Apparatus Type II paddle method at 50 RPM in 900 ml water at 37.+-.0.5.degree. C.

5. The method of claim 1, wherein the tranexamic acid or pharmaceutically acceptable salt thereof is tranexamic acid.

6. The method of claim 1, wherein a mean maximum plasma concentration (C.sub.max) of tranexamic acid of from about 5 to about 17.5 mcg/ml is provided following the administration.

7. The method 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.

8. The method 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.

9. The method 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.

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

11. The method 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 modified release material is present in an amount from about 10% to about 35% 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.

12. The method of claim 11, wherein the tranexamic acid or pharmaceutically acceptable salt thereof is tranexamic acid.
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