Intravaginal Devices With a Rigid Support, Methods of Making, and Uses Thereof

• US 20100040671A1
• Filed: 08/11/2009
• Published: 02/18/2010
• Est. Priority Date: 08/12/2008
• Status: Abandoned Application

• Current Assignee: Teva Women's Health Incorporated (Teva Pharmaceutical Industries Limited)
• Original Assignee: Teva Women's Health Incorporated (Teva Pharmaceutical Industries Limited)
• Inventors: Tsao, Jiaxiang, AHMED, Salah U.
• Application Number:
  US12/539,568
• Publication Number:
  US 20100040671A1
• Time in Patent Office: Days
• US Class Current: 424/432
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• 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 9/0036 Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
• CPC Class Codes: A61P 15/12 for climacteric disorders
• CPC Class Codes: A61P 15/18 Feminine contraceptives
• CPC Class Codes: A61P 5/30 Oestrogens
• CPC Class Codes: A61P 5/34 Gestagens

Abstract

The present invention relates to intravaginal devices having a rigid support, methods of making, and uses thereof. The devices comprise (a) a rigid support having a Shore A Hardness of at least about 20 and a tensile strength of at least about 1 MPa, (b) a matrix, and (c) an active agent dispersed in the matrix, wherein the support and the matrix are adjacent and wherein the device is annular.

Claims

1. An intravaginal device comprising:

(a) a rigid support having a Shore A Hardness of at least about 20 and a tensile strength of at least about 1 MPa;

(b) a matrix; and

(c) an active agent dispersed in the matrix;

wherein the support and the matrix are adjacent and wherein the device is annular.

2. The device of claim 1, wherein the support has a Shore A Hardness of about 20 to about 80.

3. The device of claim 1, wherein the support has a tensile strength of about 1 MPa to about 100 MPa.

4. The device of claim 1, wherein the support has a Shore A Hardness of about 20 to about 80 and a tensile strength of about 1 MPa to about 100 MPa.

5. The device of claim 1, wherein the support comprises a metal, an alloy, a plastic, composites thereof, or combinations thereof.

6. The device of claim 5, wherein the plastic comprises a thermoplastic or a thermoset plastic.

7. The device of claim 5, wherein the plastic comprises a polyalkylene, a polystyrene, a polysiloxane, a polyvinyl acetate, a polyvinyl chloride, a polyester, a polyurethane, an acrylic, a nylon, a dacron, a teflon, or combinations thereof.

8. The device of claim 7, wherein the polyalkylene comprises a high density polyethylene, a high density polypropylene, a high density polybutylene, or combinations thereof.

9. The device of claim 7, wherein the polyalkylene comprises a high density polyethylene.

10. The device of claim 1, wherein the matrix comprises a polysiloxane, a polyalkylene, a polystyrene, a polyvinyl acetate, a polyvinyl chloride, a polyester, a polyurethane, an acrylic, a nylon, a dacron, a teflon, or combinations thereof.

11. The device of claim 1, wherein the matrix is a polysiloxane, an ethylene-vinylacetate copolymer, or combinations thereof.

12. The device of claim 1, wherein the matrix encompasses at least 95% of the surface area of the support.

13. The device of claim 1, wherein the device comprises more than one matrix.

14. The device of claim 1, wherein the active agent is a steroid hormone, an anticholinergic, an anesthetic, combinations thereof, or derivatives thereof.

15. The device of claim 1, wherein the active agent is progesterone, estrogen, oxybutynin, lidocaine, danazol, etonogestrel, ethinyl estradiol, or combinations thereof.

16. The device of claim 1, wherein the device is a vaginal ring.

17. The device of claim 1, wherein the device has an outer diameter of about 40 mm to about 70 mm.

18. The device of claim 1, wherein the device has an inner diameter of about 10 mm to about 60 mm.

19. The device of claim 1, wherein the support has a cross-sectional diameter of about 0.5 mm to about 4 mm.

20. The device of claim 1, further comprising an outer sheath.

23. A method of contraception, the method comprising administering to a female the device of claim 14.

24. A method of hormone replacement therapy, the method comprising administering to a female the device of claim 14.

21. A method of making an intravaginal device having a rigid support and a matrix, the method comprising:

(i) placing the support in a mold, wherein the support has a Shore A Hardness of at least about 20 and a tensile strength of at least about 1 MPa; and

(ii) adding the matrix to the mold, wherein the matrix has an active agent dispersed therein;

wherein the support and the matrix are adjacent and wherein the device is annular.

22. An intravaginal device made by the method of claim 21.