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1. WO2020112818 - DRUG DEVICE COMBINATION FOR THE EFFECTIVE TREATMENT OF INCONTINENCE IN WOMEN

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[ EN ]

WHAT IS CLAIMED IS:

1. An intravaginal drug delivery device comprising an antimuscarinic agent dispersed in a thermoplastic matrix, wherein the thermoplastic matrix comprises thermoplastic polyurethane or polyethylene vinyl acetate.

2. The intravaginal drug delivery device of claim 1, wherein the thermoplastic matrix has a size and shape sufficient for the effective use of the device as a pessary device.

3. The intravaginal drug delivery device of claim 1, wherein the thermoplastic matrix has a size and shape of a ring pessary.

4. The intravaginal drug delivery device of claim 1, wherein the thermoplastic matrix has a size and shape of a cup pessary.

5. The intravaginal drug delivery device of any one of claims 1-4, wherein the device comprises a knob formed from the thermoplastic material.

6. The intravaginal drug delivery device of any one of claims 1 -5, wherein the thermoplastic matrix has an annular shape, with an outer diameter of between about 45 mm and about 100 mm.

7. The intravaginal drug delivery device of any one of claims 1 -6, wherein the thermoplastic matrix has an annular shape, with a cross sectional diameter of between about 3.5 mm to about 10 mm.

8. The intravaginal drug delivery device of any one of claims 1 -7, wherein the thermoplastic matrix has a compressibility force in the range of about 10N and to about 25 N.

9. The intravaginal drug delivery device of any one of claims 1-8, wherein the device comprises a plurality of segments coupled together, wherein at least one segment is composed of the antimuscarinic agent dispersed in the thermoplastic matrix.

10. The intravaginal drug delivery device of claim 9, wherein the segments are coupled together to create a device having a shape sufficient for the effective use of the device as a pessary device.

11. The intravaginal drug delivery device of any one of claims 1-10, wherein the antimuscarinic agent is tolterodine.

12. The intravaginal drug delivery device of any one of claims 1-11, wherein the device releases the antimuscarinic agent for up to 28 days with an average daily release rate between 1 and 5 mg, and wherein the intravaginal drug delivery device provides the antimuscarinic agent according to a non-zero order release profile.

13. The intravaginal drug delivery device of claim 11, wherein the concentration of antimuscarinic agent in the thermoplastic matrix is between about 5% and about 40%.

14. The intravaginal drug delivery device of any one of claims 1-13, wherein the thermoplastic matrix is polyethylene vinyl acetate.

15. The intravaginal drug delivery device of claim 14, wherein the polyethylene vinyl acetate has a vinyl acetate content between about 6 and about 40%.

16. The intravaginal drug delivery device of any one of claims 1-15, wherein the thermoplastic matrix is a thermoplastic polyurethane.

17. The intravaginal drug delivery device of any one of claims 1-16, further comprising a membrane coating at least a portion of the thermoplastic matrix, wherein the membrane alters the release rate of the antimuscarinic agent from the thermoplastic matrix.

18. The intravaginal drug delivery device of claim 17, wherein the membrane is composed of polyethylene vinyl acetate having a vinyl acetate content between about 6% and about 18%.

19. The intravaginal drug delivery device of claim 17, wherein the membrane is composed of low-density polyethylene.

20. The intravaginal drug delivery device of any one of claims 1-19, further comprising an estrogenic agent dispersed in a thermoplastic matrix, wherein the thermoplastic matrix comprises thermoplastic polyurethane or polyethylene vinyl acetate.

21. The intravaginal drug delivery device of claim 20, wherein the antimuscarinic agent and the estrogenic agent are dispersed, together, in the thermoplastic matrix.

22. The intravaginal drug delivery device of claim 20, wherein the device comprises a plurality of segments coupled together, wherein at least one segment is composed of the antimuscarinic agent dispersed in the thermoplastic matrix, and wherein at least one segment is composed of the estrogenic agent dispersed in the thermoplastic matrix.

23. The intravaginal drug delivery device of claim 20, wherein the antimuscarinic agent is tolterodine and the estrogenic agent is estriol.

24. An intravaginal drug delivery device comprising an estrogenic agent dispersed in a thermoplastic matrix, wherein the thermoplastic matrix comprises thermoplastic polyurethane or ethylene vinyl acetate, and wherein the thermoplastic matrix has a size and shape sufficient for the effective use of the device as a pessary device.

25. The intravaginal drug delivery device of claim 24, wherein the thermoplastic matrix has a size and shape of a ring pessary.

26. The intravaginal drug delivery device of claim 24, wherein the thermoplastic matrix has a size and shape of a cup pessary.

27. The intravaginal drug delivery device of any one of claims 24-26, wherein the device comprises a knob formed from the thermoplastic material.

28. The intravaginal drug delivery device of any one of claims 24-27, wherein the thermoplastic matrix has an annular shape, with an outer diameter of between about 45 mm and about 100 mm.

29. The intravaginal drug delivery device of any one of claims 24-28, wherein the thermoplastic matrix has an annular shape, with a cross sectional diameter of between about 3.5 mm to about 10 mm.

30. The intravaginal drug delivery device of any one of claims 24-29, wherein the thermoplastic matrix has a compressibility force in the range of about 10N and to about 25 N.

31. The intravaginal drug delivery device of any one of claims 24-30, wherein the device comprises a plurality of segments coupled together, wherein at least one segment is composed of the estrogenic agent dispersed in the thermoplastic matrix.

32. The intravaginal drug delivery device of claim 31, wherein the segments are coupled together to create a device having a shape sufficient for the effective use of the device as a pessary device.

33. The intravaginal drug delivery device of any one of claims 24-32, wherein the estrogenic agent is estriol.

34. The intravaginal drug delivery device of any one of claims 24-33, wherein the device releases the estrogenic agent for up to 28 days with an average daily release rate between 10 pg and 100 pg, and wherein the intravaginal drug delivery device provides the estrogenic agent according to a non-zero order release profile.

35. The intravaginal drug delivery device of any one of claims 24-34, wherein the thermoplastic matrix is polyethylene vinyl acetate.

36. The intravaginal drug delivery device of claim 35, wherein the polyethylene vinyl acetate has a vinyl acetate content between about 6 % and about 40%.

37. The intravaginal drug delivery device of any one of claims 24-36, wherein the thermoplastic matrix is a thermoplastic polyurethane.

38. The intravaginal drug delivery device of any one of claims 24-37, further comprising a membrane coating at least a portion of the thermoplastic matrix, wherein the membrane alters the release rate of the estrogenic agent from the thermoplastic matrix.

39. The intravaginal drug delivery device of claim 38, wherein the membrane is composed of polyethylene vinyl acetate having a vinyl acetate content between about 6% and about 18%.

40. The intravaginal drug delivery device of claim 38, wherein the membrane is composed of low-density polyethylene.