Contraceptive intracervical device and novel nonsystemic agents for the prevention of conception and disease

• US 5,224,493 A
• Filed: 01/30/1991
• Issued: 07/06/1993
• Est. Priority Date: 01/30/1991
• Status: Expired due to Fees

• Current Assignee: Cadco Corporation
• Original Assignee: Cadco Corporation
• Inventors: Horne, Herbert W. Jr., Dollinger, Harli M., Sawan, Samuel P.
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): RIMELL, SAMUEL G
• Application Number:
  US07/648,158
• Time in Patent Office: 888 Days
• Field of Search: 128/830, 128/832, 128/833, 128/837, 128/917
• US Class Current: 128/832
• CPC Class Codes: A61F 6/14 intra-uterine type
• 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: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

An intracervical device for the controlled release of an active agent for the prevention of both specific sexually transmitted diseases and pregnancy. The device consists of an entirely erodible polymer, or a combination of an erodible polymer with a skeletal polymer capable of maintaining therefor mechanical properties over long duration in the body. The active agents can include one or more than one of a large family of insoluble metal salts which have been shown to affect sperm motility and/or viability and are effacious in the prevention of sexually transmitted diseases. These agents are slowly released over a defined period of time ranging from one month to up to 18 months in duration due to erosion of the polymer matrix.

Claims

1. An intracervical device which comprises:

a spermicidal composition which consists of an effective amount of an agent selected from the group consisting of silver, magnesium, zinc, copper, cadmium or arsenic and their salts and oxides for use as a contraceptive device;

the agent being imbedded an excipient, the excipient comprising an erodible polymer which controls the release rate of the agent;

means to secure the device in the cervix; and

means to remove the device from the cervix.

2. The device of claim 1 wherein a metal selected fron the group consisting of silver, magnesium, zinc, copper, cadmium or arsenic is combined with a complementary anion selected from the group consisting of carbonates, phosphates, halides, lactates, oxides or peroxides to form insoluble metal salts or metal oxides.

3. The device of claim 1 wherein the agent is present in an amount of 30-50% by weight based on the weight of the excipient.

4. The device of claim 1 wherein the erodible polymer is selected from the group consisting of lactic and glycolic acids and polyanhydrides and polyesters.

5. The device of claim 1 which comprises a biostable skeletal polymer mixed with the excipient.

6. The device of claim 5 wherein the biostable polymers are selected from the group consisting of ethylene vinyl acetates, polyamides, polyalkyls, polyesters and polyethers.

7. The device of claim 5 wherein the proportion of the erodible polymer to the skeletal polymer varies from 30 to 70% in each of the respective phases.

8. The device of claim 2 wherein the agent is a silver or magnesium salt.

9. The device of claim 1 which includes:

a drug selected from the group consisting of antivirals, antibiotics, antibacterials, anti-inflammatories, or hormonal agents.

10. The device of claim 1 wherein the means to anchor the device within the cervix comprises prongs extending from the device.

11. The device of claim 1 wherein the means to secure the device in the cervix comprises a housing within which is secured the device.

12. The device of claim 11 wherein the housing comprises a polymeric support structure having prongs extending outwardly therefrom.

13. The device of claim 1 wherein the means to remove the device comprises a string.

16. The composition of claim 1 therefor wherein the erodible polymer is selected from the group consisting of lactic and glycolic acids and polyanhydrides and polyesters.

14. A spermicidal composition which consists of:

an effective amount of an agent selected from the group consisting of silver, magnesium, zinc, copper, cadmium or arsenic and their salts and oxides for use as a contraceptive device; and

an excipient, the excipient comprising an erodible polymer which controls the release rate of the agent;

said agent being imbedded in said excipient.

15. The composition of claim 14 therefor wherein a metal selected from the group consisting of silver, magnesium, zinc, copper, cadmium or arsenic is combined with a complementary anion selected from the group consisting of carbonates, phosphates, halides, lactates, oxides or peroxides to form insoluble metal salts or metal oxides.

17. The composition of claim 14 therefor which includes:

a drug selected from the group consisting of antivirals, antibiotics, antibacterials, anti-inflammatories, or hormonal agents.