Tranexamic acid formulations

CAFC
  • US 8,022,106 B2
  • Filed: 04/30/2009
  • Issued: 09/20/2011
  • Est. Priority Date: 03/04/2004
  • Status: Active Grant
First Claim
Patent Images

1. A tranexamic acid oral dosage form comprising:

  • tranexamic acid or a pharmaceutically acceptable salt thereof; and

    a modified release material which provides for the modified release of the tranexamic acid or pharmaceutically acceptable salt thereof from the dosage form such that the dosage form is suitable for administration on a two or three times a day basis;

    wherein the modified release material comprises a polymer selected from the group consisting of hydroxyalkylcelluloses, alkylcelluloses, cellulose ethers, partial esters thereof, and mixtures thereof;

    wherein the modified release material is present in the formulation in an amount from about 10% to about 35% by weight of the formulation;

    wherein said dosage form 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% tranexamic acid or pharmaceutically acceptable salt thereof released at about 15 minutes, less than about 70% by weight tranexamic acid or pharmaceutically acceptable salt thereof released at about 45 minutes and not less than about 50% by weight of said tranexamic acid or pharmaceutically acceptable salt thereof released by about 90 minutes; and

    wherein each tranexamic acid oral dosage form provides a dose of about 650 mg of tranexamic acid.

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