Tranexamic acid formulations

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° 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.