Tranexamic acid formulations

CAFC
  • US 8,273,795 B2
  • Filed: 08/13/2008
  • Issued: 09/25/2012
  • Est. Priority Date: 03/04/2004
  • Status: Active Grant
First Claim
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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°

    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.

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