Enhanced intravaginal devices

• US 6,776,164 B2
• Filed: 12/05/2000
• Issued: 08/17/2004
• Est. Priority Date: 06/05/1998
• Status: Expired due to Term

• Current Assignee: Interag
• Original Assignee: Interag
• Inventors: Rathbone, Michael John, Burggraaf, Shane, Bunt, Craig Robert
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US09/729,251
• Publication Number:
  US 20010029357A1
• Time in Patent Office: 1,351 Days
• Field of Search: 128/830-841
• US Class Current: 128/830
• CPC Class Codes: A61D 7/00 Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals for reproduction or fertilisation A61D19/00 ; devices for implanting pellets, radon seeds or the like A61M37/0069
• CPC Class Codes: A61F 6/144 with T-configuration
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/0036 Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives

Abstract

A biodegradable intra vaginal device for insertion into the vagina of an animal (eg; cattle) useful for herd oestrus synchrony purposes,

the device is intra vaginally insertable, intra vaginally retainable and withdrawable by virtue of its ability to change its geometry yet is formed at least almost exclusively from a cyclodextrin and progesterone impregnated moulded matrix of a polyester polymer (eg; poly (ε-caprolactone)) or a starch-like polysaccharide polymer. There is preferably a loading of progesterone of from 0.1 to 3 gms. The surface area of the impregnated matrix is preferably from 15 to 200 cm².

Related methods and uses also form part of the invention.

Claims

1. An intravaginal device being intravaginally insertable, retainable and withdrawable thereafter by virtue of its ability to change its geometry yet being formed solely as a molded progesterone and cyclodextrin impregnated biodegradable matrix of a biodegradable polymer selected from polyesters and starchlike polysaccharides.

2. The device of claim 1 wherein the kind and amount of cyclodextrin will enhance adsorption.

3. The device of claim 1 wherein said device has a variable geometry whereby after insertion in one geometry the device will assume another having a retention characteristic.

4. The device of claim 1 wherein said polymer is poly (ε

-caprolactone).

5. The device of claim 1 wherein said polymer is a starch-like polysaccharide.

6. The device of claim 1 wherein the cyclodextrin is hydroxypropyl β

-cyclodextrin.

7. The device of claim 1 wherein the cyclodextrin comprises from 5 to 70% w/w of the impregnated matrix.

8. The device of claim 1 wherein the progesterone comprises from 5 to 70% w/w of the impregnated matrix.

9. The device of claim 8 wherein the progesterone loading is from 0.1 to 3 gms.

10. The device of claim 8 wherein the surface area of the impregnated matrix is from 8 to 200 cm².

11. The device of claim 10 wherein said surface area is from 15 to 200 cm².

12. The device of claim 8 wherein progesterone does not appear as a fine powder or crystal upon the surface of the device.

13. An intra vaginal device for insertion into the vagina of an animal, said device being intra vaginally insertable, intra vaginally retainable and withdrawable by virtue of its ability to change geometry yet being formed at least almost exclusively from a cyclodextrin and progesterone impregnated moulding matrix of poly (ε

-caprolactone), the loading of progesterone being from 0.1 to 3 gms and the surface area of the impregnated matrix being from 8 to 200 cm².

14. The device of claim 13 wherein the surface area is from 15 to 200 cm².

16. The method of claim 13 wherein said surface area is from 15 to 200 cm².

15. A method for animal group oestrus synchrony comprising the step of utilizing an intra vaginal device, said device being intra vaginally insertable, intra vaginally retainable and withdrawable by virtue of its ability to change geometry yet being formed at least almost exclusively from a cyclodextrin and progesterone impregnated moulding matrix of poly (ε

-caprolactone), the loading of progesterone being from 0.1 to 3 gms and the surface area of the impregnated matrix being from 8 to 200 cm².

17. A method of manufacturing of an intra vaginal device an for insertion into the vagina of a target species mammal, said device being or having a moulded progesterone and cyclodextrin impregnated matrix of a biodegradable polymer selected from the group of poly esters and starch like polysaccharides, the cyclodextrin being of a kind and in such amount as will enhance release and/or adsorption

which method comprises or includes the steps of

including in the starting material(s) of said biodegradable polymer a distribution of both cyclodextrin and progesterone, and

thereafter moulding the device or the impregnated matrix of the device therefrom.

18. The method of claim 17 wherein the whole device results from the moulding.

19. The method of claim 18 wherein the progesterone comprises from 5 to 70% w/w of the impregnated matrix.

20. The method of claim 17 wherein the cyclodextrin(s) comprise from 5 to 70% w/w of the impregnated matrix.

21. The method of claim 17 wherein said progesterone and cyclodextrin are pre-mixed prior to association with said polymerisable precursor.

22. A method of achieving in an animal (or in each animal of a group of animals) a blood serum level of progesterone of greater than 2 ng/ml for a period of at least 5 days, said method comprising inserting and retaining in the or each animal for at least the 5 day period an intra vaginal device being or having a moulded progesterone and cyclodextrin impregnated matrix of a biodegradable polymer selected from the group of poly esters and starch like polysaccharides, the cyclodextrin being of a kind and in such amount as will enhance release and/or adsorption.

23. The method of claim 22 when used for herd oestrus synchrony purposes and wherein there is an additional step of withdrawing each device to allow an onset of oestrus.

24. The method of claim 23 wherein said device has a loading of from 0.1 to 3 gms of progesterone.

25. The method of claim 24 wherein said device has an impregnated matrix surface of from 8 to 200 cm².

26. The method of claim 25 wherein the surface area is from 15 to 200 cm².

27. The method of claim 23 wherein the animal(s) is or are of the cattle, sheep, goats or deer species.

28. An intra vaginal device for insertion into the vagina of a target species mammal, said device being or having a moulded progesterone and cyclodextrin impregnated matrix of a biodegradable polymer selected from the group of poly esters and starch like polysaccharides, the cyclodextrin being of a kind and in such amount as will enhance release and/or adsorption, when made by a method which includes the steps

including in the starting material(s) of said biodegradable polymer a distribution of both cyclodextrin and progesterone, and

thereafter moulding the device of the impregnated matrix of the device therefrom.