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Details for Patent: 3,903,880

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Details for Patent: 3,903,880

Title: Intrauterine device for managing the reproductive process
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:Aug 17, 1972
Application Number:05/281,446
Claims:1. In an intrauterine device for controlling fertility comprising a body of polymeric material containing a progestational steroid capable of diffusing through said polymeric material at a fertility controlling rate, said body being adapted for insertion and retention in the uterine lumen, the improvement wherein said intrauterine polymeric body is comprised of uterine acceptable ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% by weight, a melt index of 0.1 to 1,000 grams per ten minutes and permeable to the progestational steroid with the steroid dissolving in and passing through the ethylene-vinyl acetate copolymer by diffusion.

2. In an intrauterine device for controlling fertility comprising a body of polymeric material surrounding a reservoir containing from 250 nanograms to 5 grams of an anti-fertility progestational steroid capable of diffusing through said polymeric material at a fertility controlling rate, said body shaped and adapted for insertion and retention in the uterine lumen for a prolonged period of time, the improvement wherein said intrauterine polymeric body is comprised of biologically compatible ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% by weight, a melt index of about 0.1 to 1,000 grams per minute, a density having a range of about 0.920 to 0.980, and a frequency of acetoxy groups on the polyethylene backbone of 1/150 to 1/8, and permeable to the progestational steroid with the steroid dissolving in and passing through the ethylene-vinyl acetate copolymer by diffusion for releasing said progestational anti-fertility steroid in an effective amount to a uterine lumen for controlling fertility.

3. In an intrauterine device for controlling fertility according to claim 2 wherein the anti-fertility steroid is progesterone and the ethylene-vinyl acetate copolymer has a vinyl acetate content of about 4 to 50% by weight and a melt index of 0.5 to 250 grams per ten minutes.

4. A method for controlling fertility which method is comprised of placing in the uterine lumen of a warm blooded female animal an intrauterine device for controlling fertility comprising a body of a polymeric material surrounding a reservoir containing from 250 nanograms to 5 grams of an anti-fertility progestational steroid, and capable of diffusing through said polymeric material in a fertility controlling rate, said body being adapted for insertion and retention in the uterine lumen, the improvement wherein said intrauterine polymeric body is comprised of an ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% by weight, a melt index of about 0.1 to 1,000 grams per minute, a density having a range of about 0.920 to 0.980 an a frequency of acetoxy groups on the polyethylene backbone of 1/150 to 1/8, and permeable to the progestational steroid with the steroid dissolving in and passing through the ethylene-vinyl acetate copolymer by diffusion in a fertility controlling effective amount for controlling fertility in the uterine cavity.

5. A method for controlling fertility which method is comprised of placing an intrauterine device for controlling fertility of claim 4 in the uterine cavity wherein the anti-fertility agent is progesterone.

6. In an intrauterine device for controlling fertility comprising a body of polymeric material adapted for insertion and retention in the uterine lumen for a prolonged period of time, said material containing from 250 nanograms to 5 grams of a fertility controlling progestational steroid capable of diffusing through said polymeric material in an amount effective for controlling fertility, the improvement wherein the intrauterine polymeric material is comprised of essentially shaped retaining ethylene vinylacetate copolymer having a vinylacetate content of 4 to 50% by weight, a melt index of 0.5 to 250 grams per 10 minutes, a density of 0.920 to 0.980, a frequency of acetoxy groups on the polyethylene of 1/150 to 1/8 and permeable to the progestational steroid with the steroid dissolving in and passing through the ethylene vinylacetate copolymer in an effective amount for controlling fertility by diffusion.

7. In an intrauterine device for controlling fertility comprising a body of polymeric material containing from 250 nanograms to 5 grams of an anti-fertility estrogenic steroid capable of diffusing through said polymeric material at a fertility controlling rate, said body being shaped and adapted for insertion and retention in the uterine lumen for a prolonged period of time, the improvement wherein said intrauterine polymeric body is comprised of uterine acceptable ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% by weight, a melt index of about 0.1 to 1,000 grams per ten minutes, and a frequency of acetoxy groups on the polyethylene backbone of 1/150 to 1/8, and wherein the ethylene-vinyl acetate copolymer is permeable to the estrogenic steroid with the steroid dissolving in and passing through the ethylene-vinyl acetate copolymer by diffusion for controlled release to a uterine lumen in an effective amount for controlling fertility.

8. In an intrauterine device for controlling fertility comprising a body of polymeric material surrounding a reservoir containing from 250 nanograms to 5 grams of an anti-fertility estrogenic steroid capable of diffusing through said polymeric material in an effective amount for controlling fertility, said body being adapted for insertion and retention in the uterine lumen for a prolonged period of time, the improvement wherein said intrauterine polymeric body is comprised of biologically compatible ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% by weight, a melt index of about 0.1 to 1,000 grams per minute, a density having a range of about 0.920 to 0.980, and a frequency of acetoxy groups on the polyethylene backbone of 1/150 to 1/8 for releasing said anti-fertility steroid, and permeable to the estrogenic steroid with the steroid dissolving in and passing through the ethylene-vinyl acetate copolymer by diffusion for controlled release to a uterine lumen for controlling fertility.

9. A method for controlling fertility which method is comprised of placing in the uterine lumen of a warm blooded female animal an intrauterine device for controlling fertility comprising a body of a polymeric material surrounding a reservoir containing from 250 nanograms to 5 grams of an anti-fertility estrogenic steroid, and capable of diffusing through said polymeric material in a fertility controlling rate, said body being shaped and adapted for insertion and retention in the uterine lumen for a prolonged period of time, the improvement wherein said intrauterine polymeric body is comprised of an ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% by weight, a melt index of about 0.1 to 1,000 grams per minute, a density having a range of about 0.920 to 0.980 and a frequency of acetoxy groups on the polyethylene backbone of 1/150 to 1/8, and permeable to the estrogenic steroid with the steroid dissolving in and passing through the ethylene-vinyl acetate copolymer by diffusion in a fertility controlling effective amount for controlling fertility in a uterine cavity.

10. In an intrauterine device for controlling fertility comprising a body of polymeric material surrounding a reservoir containing from 250 nanograms to 5 grams of a fertility controlling estrogenic steroid and capable of diffusing through said polymeric material in an effective amount for controlling fertility, said body being shaped and adapted for insertion and retention for a prolonged period of time in the uterine lumen, the improvement wherein the intrauterine polymeric body is comprised of essentially shaped retaining pharmaceutically acceptable ethylene-vinyl acetate copolymer having a vinyl acetate content of 4 to 50% by weight, a melt index of 0.5 to 250 grams per ten minutes, a density of 0.920 to 0.980, a frequency of acetoxy groups on the polyethylene backbone of 1/150 to 1/8, and permeable to the estrogenic steroid with the steroid dissolving in and passing through the ethylene-vinyl acetate copolymer by diffusion in an effective amount for controlling fertility in a uterine lumen.
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