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Details for Patent: 4,016,251

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Details for Patent: 4,016,251

Title: Vaginal drug dispensing device
Abstract:Drug-delivery device for releasing a drug at a continuous and controlled rate for a prolonged period of time is comprised of a shaped body of polymeric material containing a pharmaceutically acceptable drug and permeable to passage of the drug by diffusion. The polymeric material is an ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% by weight and a melt index of about 0.1 to 1000 grams per 10 minutes.
Inventor(s): Higuchi; Takeru (Lawrence, KS), Hussain; Anwar (Lawrence, KS)
Assignee: Alza Corporation (Palo Alto, CA)
Filing Date:May 30, 1975
Application Number:05/582,131
Claims:1. A vaginal insert comprising a reservoir for containing a drug, a drug in the reservoir, a polymeric barrier through which the drug passes by diffusion as it is released from the reservoir, the improvement wherein said barrier is an ethylene-vinyl acetate copolymer having a vinyl acetate content of 4 to 80% by weight and a melt index of about 0.1 to 1000 grams per ten minutes.

2. A vaginal dispensing device shaped and size adapted for insertion and placement in the vagina and formed of a non-toxic, flexible, polymeric release rate controlling material containing a vaginal acceptable drug capable of diffusing through the material at a controlled and continuous rate over a prolonged period of time, the improvement wherein said polymeric material is comprised of an ethylene-vinyl acetate copolymer having a vinyl acetate content of 4 to 80% by weight and a melt index of about 0.1 to 1000 grams per ten minutes.

3. A vaginal dispensing device according to claim 2 wherein the ethylene-vinyl acetate copolymer has a vinyl acetate content of 4 to 50%, a frequency of acetoxy groups on the polyethylene backbone of 1/150 to 1/8 and a density of 0.920 to 0.980.

4. A vaginal dispensing device according to claim 2 wherein the drug is an anti-infective drug.

5. A vaginal dispensing device according to claim 2 wherein the device is ring-shaped with drug housed therein.

6. A vaginal dispensing device according to claim 2 wherein the drug is a member selected from the group consisting of progestational and estrogenic steroids.

7. A vaginal dispensing device according to claim 6 wherein the device contains from 250 nanograms to 5 grams of the drug.

8. A vaginal dispensing device comprising a polymeric membrane surrounding a reservoir containing a drug and formed of a drug release rate controlling material, the improvement wherein the material is comprised of a biologically compatible ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% and a melt index of 0.1 to 1000 grams per ten minutes, and wherein said drug is dispensed from the device at a controlled and continuous rate over a prolonged period of time by passing through the copolymer.

9. A vaginal dispensing device according to claim 8 wherein the device is a container and said drug is contained in the interior thereof.

10. A vaginal dispensing device according to claim 8 wherein the reservoir is comprised of a solid matrix with drug therein.

11. A vaginal dispensing device according to claim 8 wherein the copolymer has a vinyl acetate content of 4 to 50%, a frequency of acetoxy groups on the polyethylene backbone of 1/150 to 1/8 and a density of 0.920 to 0.980.

12. A vaginal dispensing device according to claim 8 wherein the drug is a member selected from the group consisting of progestational, estrogenic and anti-infective drugs.

13. A vaginal dispensing device according to claim 12 wherein the device contains from 250 nanograms to 5 grams of the drug.

14. A vaginal dispensing device according to claim 12 wherein the progestational drug is progesterone.

15. A vaginal dispensing device according to claim 12 wherein the progestational drug is a member selected from the group consisting of 19-nor-progesterone, norethinione, medroxyprogesterone, norethynodrel and 17.alpha.-hydroxy-progesterone.

16. A vaginal dispensing device according to claim 12 wherein the anti-infective drug is a member selected from the group consisting of penicillin, tetracycline, chloramphenicol, sulfacetamide, sulfamethazine, sulfadiazine, sulfamerazine, sulfamethizole and sulfisoxazole.

17. A vaginal dispensing device according to claim 8 wherein the drug is a member selected from the group of anti-inflammatories consisting of hydrocortisone, cortisone, dexamethasone, fluocinolone, triamincolone, medrysone, and prednisolone.

18. A vaginal dispensing device according to claim 12 wherein the estrogenic drug is a member selected from the group consisting of estrone, 17.beta.-estradiol and ethinyl estradiol.

19. A vaginal dispensing device according to claim 8 wherein the reservoir is comprised of a liquid matrix with drug therein.

20. A vaginal dispensing device according to claim 8 wherein the device is ring-shaped with drug housed in the reservoir thereof.

21. A method for controlling fertility which method is comprised of placing in the vagina of a warm blooded animal a vaginal dispensing device shaped and size adapted for insertion and comfortable placement in the vagina and formed of a non-toxic, flexible, polymeric release rate controlling material containing a dosage unit amount of a vaginally acceptable antifertility steroid selected from the group consisting of progestational and estrogenic steroids capable of diffusing through the material at a controlled and continuous rate of a prolonged period of time, the improvement wherein said polymeric material is comprised of an ethylene-vinyl acetate copolymer having a vinyl acetate content of 4 to 80% by weight and a melt index of 0.1 to 1000 grams per ten minutes and permeable to the steroid with the steroid dissolving in an passing through the ethylene-vinyl acetate copolymer in a fertility controlling effective amount for controlling fertility in the animal.

22. A method for controlling fertility which method is comprised of placing in the vagina of a warm blooded animal a vaginal dispensing device shaped and size adapted for insertion and comfortable placement in the vagina and formed of a polymeric membrane surrounding a reservoir containing a dosage unit amount of a vaginally acceptable antifertility steroid selected from the group consisting of progestational and estrogenic steroids capable of diffusing through the material in a controlled rate and continuously over a prolonged period of time, the improvement wherein the material is comprised of a vaginal compatible ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% and a melt index of 0.1 to 1000 grams per ten minutes and to the steroid with the steroid dissolving in and passing through the ethylene-vinyl acetate copolymer in a fertility controlling effective amount for controlling fertility in the animal.
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