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1. WO2020117546 - PHARMACEUTICAL FORMULATIONS AND COMPOSITIONS SUITABLE TO TREAT MUCOSITIS

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[ EN ]

CLAIMS

1. A pharmaceutical composition suitable for use to treat mucositis (including oral mucositis) in an animal (human) suffering from mucositis, said composition comprising an anti-inflammatory (non-inflammatory) first fraction of a form of exogenous hyaluronic acid selected from hyaluronic acid, a pharmaceutically acceptable salt thereof, a pharmaceutically acceptable ester thereof, a fraction thereof and a subunit thereof, which are anti-inflammatory (non-inflammatory), and

an anti-inflammatory (non-inflammatory) second fraction of exogenous hyaluronic acid selected from hyaluronic acid, a pharmaceutically acceptable salt thereof, a pharmaceutically acceptable ester thereof, a fraction thereof, and a subunit thereof, the form of hyaluronic acid in the second fraction having a molecular weight between about 150000 and about 750000 Daltons,

the first fraction form of hyaluronic acid having a lower molecular weight than the second fraction form of hyaluronic acid,

and the first fraction having a lower viscosity than the second fraction.

2. The pharmaceutical composition of claim 1 wherein the molecular weight of the anti-inflammatory (non-inflammatory) form of hyaluronic acid of the first fraction is selected from a form of hyaluronic acid having a molecular weight between about (1200) 2000 and about 5000 Daltons, a form of hyaluronic acid having a molecular weight about 7.5 kDaltons and a form of hyaluronic acid having a molecular weight between about 16000 and about 20000 Daltons, and combinations of the forms which together are anti-inflammatory (noninflammatory).

3. The pharmaceutical composition of claim 1 further comprising a pharmaceutically tolerable non-toxic amount of COX-1 and or COX-2 inhibitor which is not a form of hyaluronic acid.

4. The pharmaceutical composition of claim 2 further comprising a pharmaceutically tolerable non-toxic amount of COX-1 and/or COX-2 inhibitor which is not a form of hyaluronic acid.

5. The pharmaceutical composition of claim 3 wherein the inhibitor is selected from diclofenac, diclofenac sodium and another pharmaceutically tolerable salt of diclofenac.

6. The pharmaceutical composition of claim 4 wherein the inhibitor is selected from diclofenac, diclofenac sodium, and another pharmaceutically tolerable salt of diclofenac.

7. The pharmaceutical composition of claim 1 wherein the first fraction is between about .5 percent and about 3 percent of the composition and the second fraction is between about 2 percent and about 4 percent of the composition.

8. The pharmaceutical composition of claim 2 wherein the first fraction is between about .5 percent and about 3 percent of the composition and the second fraction is between about 2 percent and about 4 percent of the composition.

9. The pharmaceutical composition of claim 3 wherein the first fraction is between about .5 percent and about 3 percent of the composition and the second fraction is between about 2 percent and about 4 percent of the composition.

10. The pharmaceutical composition of claim 3 wherein the inhibitor is selected from diclofenac and a pharmaceutically non-toxic salt of diclofenac including diclofenac sodium and includes a taste masker.

11. The pharmaceutical composition of claim 4 wherein the inhibitor is selected from diclofenac and a pharmaceutically non-toxic salt of diclofenac including diclofenac sodium and includes a taste masker.

12. The pharmaceutical composition of claim 5 wherein the inhibitor is selected from diclofenac and a pharmaceutically non-toxic salt of diclofenac including diclofenac sodium and includes a taste masker.

13. The pharmaceutical composition of claim 6 wherein the inhibitor is selected from diclofenac and a pharmaceutically non-toxic salt of diclofenac including diclofenac sodium a taste masker.

14. The pharmaceutical composition of claim 9 wherein the inhibitor is selected from diclofenac and a pharmaceutically non-toxic salt of diclofenac including diclofenac sodium and includes a taste masker.

15. The pharmaceutical composition of claim 3 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

16. The pharmaceutical composition of claim 4 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

17. The pharmaceutical composition of claim 5 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

18. The pharmaceutical composition of claim 6 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

19. The pharmaceutical composition of claim 9 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

20. The pharmaceutical composition of claim 10 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

21. The pharmaceutical composition of claim 11 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

22. The pharmaceutical composition of claim 12 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

23. The pharmaceutical composition of claim 13 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

24. The pharmaceutical composition of claim 14 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

25. A method of treating mucositis in a human, the method comprising the application of an effective amount of a pharmaceutical composition directly to the site of the mucositis thereby to treat the mucositis, the pharmaceutical composition comprising

an anti-inflammatory (non-inflammatory) first fraction of a form of exogenous hyaluronic acid selected from hyaluronic acid, a pharmaceutically acceptable salt thereof, a pharmaceutically acceptable ester thereof, a fraction thereof and a subunit thereof, which are anti-inflammatory (non-inflammatory),

and

an anti-inflammatory (non-inflammatory) second fraction of exogenous hyaluronic acid selected from hyaluronic acid, a pharmaceutically acceptable salt thereof, a pharmaceutically acceptable ester thereof, a fraction thereof, and a subunit thereof, the form of hyaluronic acid in the second fraction having a molecular weight between about 150000 and about 750000 Daltons,

the first fraction form of hyaluronic acid having a lower molecular weight than the second fraction form of hyaluronic acid,

and the first fraction having a lower viscosity than the second fraction.

26. The method of treatment of claim 25 wherein the molecular weight

of the anti-inflammatory (non-inflammatory) form of hyaluronic acid of the first fraction is selected from a form of hyaluronic acid having a molecular weight

between about 2000 and about 5000 Daltons, a form of hyaluronic acid having a molecular weight about 7.5 kDaltons and a form of hyaluronic acid having a molecular weight between about 16000 and about 20000 Daltons, and combinations of the two forms which together are anti-inflammatory (noninflammatory).

27. The method of treatment of claim 25 further comprising a pharmaceutically tolerable non-toxic amount of COX-1 and/or COX-2 inhibitor which is not a form of hyaluronic acid.

28. The method of treatment of claim 26 further comprising a pharmaceutically tolerable non-toxic amount of COX-1 and/or COX-2 inhibitor which is not a form of hyaluronic acid.

29. The method of treatment of claim 27 wherein the inhibitor is selected from diclofenac, diclofenac sodium and another pharmaceutically tolerable salt of diclofenac.

30. The method of treatment of claim 28 wherein the inhibitor is selected from diclofenac, diclofenac sodium, and another pharmaceutically tolerable salt of diclofenac.

31. The method of treatment of claim 25 wherein the first fraction is between about .5 percent and about 3 percent of the composition and the second fraction is between about 2 percent and about 4 percent of the composition.

32. The method of treatment of claim 26 wherein the first fraction is between about .5 percent and about 3 percent of the composition and the second fraction is between about 2 percent and about 4 percent of the composition.

33. The method of treatment of claim 27 wherein the first fraction is between about .5 percent and about 3 percent of the composition and the second fraction is between about 2 percent and about 4 percent of the composition.

34. The method of treatment of claim 27 wherein the inhibitor is selected from diclofenac and a pharmaceutically non-toxic salt of diclofenac including diclofenac sodium.

35. The method of treatment of claim 28 wherein the inhibitor is selected from diclofenac and a pharmaceutically non-toxic salt of diclofenac including diclofenac sodium.

36. the method of treatment of claim 29 wherein the inhibitor is selected from diclofenac and a pharmaceutically non-toxic salt of diclofenac including diclofenac sodium.

37. The method of treatment of claim 30 wherein the inhibitor is selected from diclofenac and a pharmaceutically non-toxic salt of diclofenac including diclofenac sodium.

38. The method of treatment of claim 33 wherein the inhibitor is selected from diclofenac and a pharmaceutically non-toxic salt of diclofenac including diclofenac sodium and further includes s taste masker.

39. The method of treatment of claim 27 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

40. The method of treatment of claim 28 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

41. The method of treatment of claim 29 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

42. The method of treatment of claim 30 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

43. The method of treatment of claim 33 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

44. The method of treatment of claim 34 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

45. The method of treatment of claim 35 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

46. The method of treatment of claim 36 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

47. The method of treatment of claim 37 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

48. The method of treatment of claim 37 wherein the inhibitor comprises between about 2 ½ percent and about 4 percent of the pharmaceutical composition.

49. The use of a pharmaceutical composition for treating mucositis in a human, the use comprising the application of an effective amount of a pharmaceutical composition directly to the site of the mucositis thereby to treat the mucositis, the pharmaceutical composition comprising a pharmaceutical composition selected from claim 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24.

50. The use of a pharmaceutical composition for treating oral mucositis in a human, the use comprising the application of an effective amount of a pharmaceutical composition directly to the site of the oral mucositis thereby to treat the oral mucositis, the pharmaceutical composition selected from claim 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24.