Device for delivering agent in vagina

• US 4,402,695 A
• Filed: 03/30/1981
• Issued: 09/06/1983
• Est. Priority Date: 01/21/1980
• Status: Expired due to Fees

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Wong, Patrick S.
• Primary Examiner(s): ROSENBAUM, C FRED
• Application Number:
  US06/249,005
• Time in Patent Office: 890 Days
• Field of Search: 128/127-130, 128/260-261, 604/890-892
• US Class Current: 424/432
• CPC Class Codes: A61F 6/08 Pessaries, i.e. devices worn in the vagina to support the uterus, remedy a malposition or prevent conception , e.g. combined with devices protecting against contagion
• 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

Abstract

An intravaginal therapeutic system for the pre-programmed, unattended delivery of a drug is disclosed. The system comprises (a) a drug, (b) a delivery module comprising a reservoir for storing the drug in an amount for execution of the program, a rate controller which maintains the rate of drug delivered in a therapeutically effective amount throughout the life of the system, an energy source for transferring drug from the reservoir to the vagina, and a portal for releasing the drug from the module to the vagina, (c) a platform which integrates the module into a unit sized, shaped and adapted for insertion and retention in a vagina, and (d) therapeutic program which provides for the controlled release of drug to produce a beneficial effect over a prolonged period of time.

Claims

1. A method for regulating the ovulatory cycle in a woman, which method comprises the steps of:

a. positioning in the vagina of the woman a device for delivering a member selected from the group consisting of a progestational and estrogenic hormone, said device comprising;

1. a wall formed of a non-toxic tube shaped polymeric material united at its ends by a coupling placed within the tube, which wall surrounds;

2. an internal reservoir containing the hormone, and a carrier for the hormone; and

b. delivering the hormone to the vagina at a preprogrammed, continuous and controlled rate from the device in an effective amount for regulating the ovulatory cycle.

2. The method for regulating the ovulatory cycle according to claim 1 wherein the coupling is a solid material.

3. The method for regulating the ovulatory cycle according to claim 1 wherein the coupling has a passageway therethrough.

4. The method for regulating the ovulatory cycle according to claim 1 wherein the device delivers the progestational hormone in an effective amount for 21 days for regulating the ovulatory cycle.

5. The method for regulating the ovulatory cycle according to claim 1 wherein the device delivers the progestational hormone and the device is placed in the vagina on the fifth day of the ovulatory cycle.

6. The method for regulating the ovulatory cycle according to claim 1 wherein the device delivers the progestational hormone, and the device is placed in the vagina on the fifth day of the ovulatory cycle counting the first day of menstrual bleeding as day one of the ovulatory cycle, and wherein the device is removed from the vagina for one week after three weeks in the vagina.

7. The method for regulating the ovulatory cycle according to claim 1, wherein the device delivers the progestational and estrogenic hormone in an effective amount for twenty-one days for regulating the ovulatory cycle.

8. The method for regulating the ovulatory cycle according to claim 1, wherein the device delivers the progestational and estrogenic hormones, and the device is placed in the vagina on the fifth day of the ovulatory cycle.

9. The method for regulating the ovulatory cycle according to claim 1 wherein the device delivers the progestational and estrogenic hormone, and the device is placed in the vagina on the fifth day of the ovulatory cycle counting the first day of menstrual bleeding as day one of the ovulatory cycle, and wherein the device is removed from the vagina for one week after three weeks in the vagina.

10. The method for regulating the ovulatory cycle according to claim 1, wherein the polymeric material is a thermoplastic.

11. The method for regulating the ovulatory cycle according to claim 1 wherein the polymeric material is microporous.

12. The method for regulating the ovulatory cycle according to claim 1 wherein the polymeric material releases the hormone by diffusion.

13. A method for delivering a spermicide to a vagina, which method comprises:

a. placing in the vagina a device adapted, shaped and sized for easy placing and comfortable retention in the vagina, the device comprising;

1. a wall formed of a non-toxic tube shaped polymeric material joined at its ends by a coupling placed within the tube, which wall surrounds;

2. an internal reservoir containing a spermicide and a carrier for the spermicide; and

,

b. delivering the spermicide to the vagina at a preprogrammed, continuous and controlled rate from the device over time.

14. The method for delivering the spermicide to the vagina according to claim 13, wherein the coupling is a solid insert, and the spermicide is delivered in an effective amount for producing a spermicidal environment in the vagina.

15. The method for delivering the spermicide to the vagina according to claim 13, wherein the coupling has a passageway therethrough, and the spermicide is delivered in an effective amount for rendering ineffective sperm in the the vagina.

16. The method for delivering the spermicide to the vagina according to claim 13, wherein spermicide is a member selected from the group consisting of anionic, cationic and non-ionic surface active spermicides.

17. The method for delivering the spermicide to the vagina according to claim 13, wherein the spermicide is a member selected from the group consisting of di-isobutylphenoxypolyethoxy ethanol, dodecaethylene monolaurate, p-methanylphenyl polyoxyethylene ether, methoxypolyoxyethylene glycol laurate, nonylphenoxypolyethoxy ethanol, polyethyleneglycol monoisoctyl phenol ether, and polyoxyethylenenonyl phenol.

18. The method for delivering the spermicide to the vagina according to claim 13 wherein the polymeric material is a thermoplastic polymer.

19. The method for delivering the spermicide to the vagina according to claim 13 wherein the polymeric material is a microporous polymer.

20. The method for delivering the spermicide to the vagina according to claim 13 wherein the polymeric material releases the hormone by diffusion.

21. A method for relieving menopausal and postmenopausal symptoms in a woman, which method comprises:

a. placing in the vagina of the woman a drug delivery device adapted, shaped and sized for easy placement and comfortable retention in the vagina, the device comprising;

1. a wall formed if a non-toxic tube shaped polymeric material joined at its end, with the wall surrounding

2. an internal reservoir containing a dosage amount of an estrogenic hormone and a carrier for the steroid; and

b. delivering the estrogenic steroid to the vagina at a preprogrammed, continuous and controlled rate in a therapeutically effective amount for relieving the symptoms over time.

22. A method for managing estrogen replacement therapy in a woman, which method comprises the steps of:

a. inserting in the vagina of a woman needing estrogen replacement, a vaginal drug delivery device adapted, shaped and sized for easy insertion and comfortable retention in the vagina, said device comprising;

1. a wall formed of a non-toxic tube shaped polymeric material joined in a fluid tight relation at its end, with the wall surrounding and forming;

2. an internal reservoir containing the estrogen steroid, and a carrier therefore; and

b. delivering the estrogen from the device to the vagina in a continuous and controlled rate, and in a therapeutically effective amount useful for estrogen replacement therapy.

23. The method for managing estrogen replacement therapy in a woman according to claim 22 wherein the woman needing estrogen replacement is climacteric woman.

24. The method for managing estrogen replacement therapy in a woman according to claim 22 wherein the reservoir contains a dosage amount of the estrogen steroid for substantially performing the replacement therapy, and the estrogen steroid is a member selected from the group consisting of estradiol, estradiol benzoate, estradiol cypionate, estradiol dipropionate, estradiol enanthate, conjugated estrogen, estriol, estrone, estrone sulfate, ethinyl estradiol, estrofurate, estrogen, quinestrol and mestranol.

25. The method for managing estrogen replacement therapy in a woman according to claim 22 wherein the polymeric material is a thermoplastic polymer.

26. The method for managing estrogen replacement therapy in a woman according to claim 22 wherein the polymeric material is a microporous polymer.

27. The method for managing estrogen replacement therapy in a woman according to claim 22 wherein the device releases the steroid by diffusion.

28. A vaginal device adapted and sized for easy insertion and comfortable retention in a vagina, the device comprising:

a shaped tube formed of microporous polymer and joined by a coupling inserted into the ends of the tube to form a device with an internal reservoir, said reservoir containing a drug and a carrier for the drug, which drug is released by the device at a controlled rate and in a therapeutically effective amount over a prolonged period of time.

29. The vaginal device adapted and sized for easy insertion and comfortable retention in the vagina according to claim 28, wherein the coupling has an outside diameter approximately equivalent to the inside diameter of the tube for essentially joining the tube ends in a liquid tight union.

30. The vaginal device adapted and sized for easy insertion and comfortable retention in the vagina according to claim 28 wherein the device has an annular shape and the coupling has a diameter approximately equivalent to the inside diameter of the tube for forming an essentially liquid imperivous union.

31. The vaginal device adapted and sized for easy insertion and comfortable retention in the vagina according to claim 28 wherein the coupling inserted into the tube is a solid polymer insert.

32. The vaginal device adapted and sized for easy insertion and comfortable retention in the vagina according to claim 28 wherein the coupling has a passageway therethrough for the carrier to flow in the reservoir.

33. The vaginal device adapted and sized for easy insertion and comfortable retention in the vagina according to claim 28 wherein the coupling is solvent bonded to the inside of the tube.

34. The vaginal device adapted and sized for easy insertion and comfortable retention in the vagina according to claim 28 wherein the coupling is adhesively joined to the inside of the tube.

35. The vaginal device adapted and sized for easy insertion and comfortable retention in the vagina according to claim 28 wherein the coupling is made from a hydrophilic polymer.

36. The vaginal device adapted and sized for easy insertion and comfortable retention in the vagina according to claim 28 wherein the carrier is a member selected from the group consisting of a liquid, water, saline, buffer, oil, emulsion and glycol.

37. The vaginal device adapted and sized for easy insertion and comfortable retention in the vagina according to claim 28 wherein the device is annular shaped and at its maximum dimensions measures from a loci on the curved tube to a loci on the distant curved tube of from 0.4 cm to 16 cm, and the coupling within the tube at its ends is in mated relation therewith to form an end to end liquidtight connection.

38. The vaginal device adapted and sized for easy insertion and comfortable retention in the vagina according to claim 28 wherein the tube comprises wall forming microporous polymer that is non-toxic and non-irritating to the vaginal tissues.