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US 8,273,795 B2Granted
Tranexamic acid formulations
AssigneeFerring B.V.
InventorsKeith A. Moore, Ralph A. Heasley, Jeffrey S. Greiwe, John W. Facemire, Jason D. Modest
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Abstract
Disclosed are modified release oral tranexamic acid formulations and methods of treatment therewith.
Claims12
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.
6 more elements
Dependencies are inferred from the claim text.