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1. WO1997025051 - ORAL ADMINISTRATION OF EFFECTIVE AMOUNTS OF FORMS OF HYALURONIC ACID

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[ EN ]

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE PROPERTY OR PRIVILEGE IS CLAIMED ARE AS FOLLOWS:

1. An orally administrable dosage of a form of hyaluron comprising suitable excipients for oral administration and an effective amount of at least one of the following:
(i) between about 3 mg of the form of hyaluronan /kg
to about 100 mg of the form of hyaluronan /kg of the
body weight of the human taking the orally
administrable dosage
and
(ii) the form of hyaluronan in the orally administrable
dosage having a mean average molecular weight
distribution in the range selected from the following
group of ranges of molecular weights:
(a) a range between about 30,000 and greater than
80,000 daltons (determined by either the Protein
Standard),
(b) a range between about 30,000 daltons and about
2,000,000 daltons (determined by the Dextran
Standard)
wherein the form of hyaluronan is selected from hyaluronan and pharmaceutically acceptable salts thereof.

2 The orally administrable dosage of claim 1 in accordance with subparagraph (i).

3. The orally administrable dosage of claim 1 in accordance with subparagraph (ii).

4. The orally administrable dosage of claim 1 in accordance with subparagraph (ii) (a).

5. The orally administrable dosage of claim 1 in accordance with subparagraph (ii) (b).

6. The orally administrable dosage of claim 1 in accordance with both subparagraphs (i) and (ii).

7. The orally administrable dosage of claim 1, 2, 3, 4, 5 or 6 wherein the form of hyaluronan is present between about 3 mg/kg and about lOmg/kg of the human of the form of hyaluronan.

8. The orally administrable dosage of claim 1, 2, 3, 4, 5 or 6 wherein the form of hyaluronan is present between about 3 mg/kg and about 30mg/kg of the human of the form of hyaluronan.

9. The orally administrable dosage of claim 2 wherein the mean average molecular weight distribution of the form of hyaluronan is less than 750,000 daltons (Protein Standard).

10. The orally administrable dosage of claim 2 wherein the mean average molecular weight distribution is about 400,000 daltons (Protein Standard).

11. An orally administrable dosage of a form of hyaluronan in a suitable excipient wherein the form of hyaluronan is selected from hyaluronan and pharmaceutically acceptable salts thereof and wherein the oral dosage provides a mean average molecular weight distribution in the blood system between about 30,000 and greater than 70,000 daltons (Protein Standard).

12. An orally administrable dosage of a form of hyaluronan in a suitable excipient wherein the form of hyaluronan is selected from hyaluronan and pharmaceutically acceptable salts thereof and wherein the oral dosage provides a mean average molecular weight distribution in the blood system between about 30,000 and about 2,000,000 daltons (Dextran Standard).

13. The orally administrable dosage of claim 11 or 12 wherein the form of hyaluronan is between about 3 mg of the form of hyaluronan/kg to about 100 mg of the form of hyaluronan/kg of the body weight of the human taking the orally administrable dosage.

14. The orally administrable dosage of claim 11 or 12 wherein the form of hyaluronan is present between about 3 mg/kg and about 30mg/kg of the human of the form of hyaluronan.

15. The orally administrable dosage of claim 11 or 12 wherein the form of hyaluronan is present between about 3 mg/kg and about lOmg/kg of the human of the form of hyaluronan.

16. The orally administrable dosage of the form of hyaluronan according to claim 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 further comprising a therapeutically effective amount of medicine and /or therapeutic agent.

17. A method of treating or preventing a condition or disease which may employ the use of a form of hyaluronan in the treatment or preventative measure, the method comprising orally administering an effective amount of an orally administrable dosage of a form of hyaluron comprising suitable excipients for oral administration and an effective amount of at least one of the following:

(i) between about 3 mg of the form of hyaluronan /kg
to about 100 mg of the form of hyaluronan /kg of the
body weight of the human taking the orally
administrable dosage
and
(ii) the form of hyaluronan in the orally administrable
dosage having a mean average molecular weight
distribution in the range selected from the following
group of ranges of molecular weights:
(a) a range between about 30,000 and greater than
70,000 daltons (determined by either the Protein
Standard or the Dextran Standard),
(b) a range between about 30,000 daltons and about
2,000,000 daltons (determined by the Dextran
Standard)
wherein the form of hyaluronan is selected from hyaluronan and pharmaceutically acceptable salts thereof, the said administration continuing over such period of time as required.

18. The method of claim 17 wherein the orally administrable dosage is in accordance with subparagraph (i).

19. The method of claim 17 wherein the orally administrable dosage is in accordance with subparagraph (ii).

20. The method of claim 17 wherein the orally administrable dosage is in accordance with subparagraph (ii) (a).

21. The method of claim 17 wherein the orally administrable dosage is in accordance with subparagraph (ii) (b).

22. The method of claim 17 wherein the orally administrable dosage is in accordance with both subparagraphs (i) and (ii).

23. The method of claim 17, 18, 19, 20, 21 or 22 wherein the form of hyaluronan is present between about 3 mg/kg and about 30mg/kg of the human of the form of hyaluronan.

24. The method of claim 17, 18, 19, 20, 21 or 22 wherein the form of hyaluronan is present between about 3 mg/kg and about lOmg/kg of the human of the form of hyaluronan.

25. The method of claim 18 wherein the mean average molecular weight distribution of the form of hyaluronan is less than 750,000 daltons (Protein Standard).

26. The method of claim 18 wherein the mean average molecular weight distribution is about 400,000 daltons.

27. A method of treating or preventing a condition or disease which may employ the use of a form of hyaluronan in the treatment or preventative measure, the method comprising administering an effective amount of an orally administrable dosage of a form of hyaluronan in a suitable excipient wherein the form of hyaluronan is selected from hyaluronan and pharmaceutically acceptable salts thereof and wherein the oral dosage provides a mean average molecular weight distribution in the blood system between about 30,000 and greater than 70,000 daltons (Protein Standard), the said administration continuing over such period of time as required.

28. A method of treating or preventing a condition or disease which may employ the use of a form of hyaluronan in the treatment or preventative measure, the method comprising administering an effective amount of an orally administrable dosage of a form of hyaluronan in a suitable excipient wherein the form of hyaluronan is selected from hyaluronan and pharmaceutically acceptable salts thereof and wherein the oral dosage provides a mean average molecular weight distribution in the blood system between about 30,000 and about 2,000,000 daltons (Dextran Standard), the said administration continuing over such period of time as required.

29. The method of claim 27 or 28 wherein the form of hyaluronan is between about 3 mg of the form of hyaluronan /kg to about 100 mg of the form of hyaluronan /kg of the body weight of the human taking the orally administrable dosage.

30. The method of claim 27 or 28 wherein the form of hyaluronan is present between about 3 mg/kg and about 30mg/kg of the human of the form of hyaluronan.

31. The method of claim 27 or 28 wherein the form of hyaluronan is present between about 3 mg/kg and about lOmg/kg of the human of the form of hyaluronan.

32. The method of claim 17, 18 19, 20, 21, 22, 23, 24, 25, 26, 27, 28,

29, 30 or 31 wherein the orally administrable dosage further comprises a therapeutically effective amount of a medicine and/or therapeutic agent.

33. The method of claim 17, 27 or 28 wherein the treatment or preventing of disease or condition is the prevention of restenosis.

34. The method of claim 33 wherein the period of time of administration is over a 3-5 day period.