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Details for Patent: 4,188,951

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Details for Patent: 4,188,951

Title: Intrauterine system embracing selected copolymeric membranes for administering beneficial agent
Abstract:An intrauterine system for releasing beneficial agent to the uterus at a controlled and continuous rate for a prolonged period of time is disclosed. The system is shaped, sized and adapted for insertion and retention in the uterus. The system contains a beneficial agent and it is formed of a copolymeric material permeable to the passage of agent by diffusion. The material is an ethylene-vinyl ester polymer of the general formula: ##STR1## wherein R is hydrogen, alkyl of 2 to 7 carbons, or aryl, m is (4 to 80)% by weight and n is (100-m)% by weight.
Inventor(s): Higuchi; Takeru (Lawrence, KS), Hussain; Anwar A. (Lexington, KY)
Assignee: Alza Corporation (Palo Alto, CA)
Filing Date:Aug 22, 1977
Application Number:05/826,928
Claims:1. An intrauterine system for the controlled administration of an anti-fertility agent in an effective amount to the uterus of a warm blooded mammal, said system comprising a flexible body of a copolymeric material containing a progestational steroid capable of diffusing through said copolymeric material, said body sized, shaped and adapted for comfortable insertion and retention in the uterine lumen, and wherein said material comprises a copolymer of the following formula: ##STR16## wherein R is a member selected from the group consisting of a lower alkyl group of 2 to 7 carbons and phenyl, m is (4 to 80)% by weight, n is (100-n)% by weight, and which copolymer has a melt index of about 0.1 to 1000 grams per ten minutes.

2. The intrauterine system according to claim 1, wherein the copolymer contains from 250 nanograms to 5 grams of progestational steroid, has a frequency of acyloxy groups on the copolymeric backbone of 1/200 to 1/35, and a density of 0.120 to 1.25.

3. The intrauterine system according to claim 1, wherein the progestational steroid is progesterone and the copolymer has a vinyl ester content of 4 to 50% by weight and a melt index of 0.5 to 250 grams per ten minutes.

4. An intrauterine system for the controlled administration of an anti-fertility agent in an effective amount to the uterus of a warm-blooded mammal, said system comprising a body of copolymeric material surrounding a reservoir containing an anti-fertility progestational steroid capable of diffusing through said copolymeric material, said body sized, shaped and adapted for insertion and retention in the uterine lumen for a prolonged period of time, and wherein said material comprises a copolymer of the following formula: ##STR17## wherein the copolymer has a vinyl ester content m of about (4 to 80)% by weight, an ethylene content n of (100-m)%, a melt index of about 0.1 to 1000 grams per ten minutes, and R is a member selected from the group consisting of lower alkyl of 2 to 7 carbon atoms and phenyl.

5. The intrauterine system according to claim 4 wherein the copolymer has a frequency of acyloxy groups on the copolymeric backbone of 1/200 to 1/35, a density of 0.120 to 1.25, and the reservoir is a container with from 250 nanograms to 5 grams of progestational steroid housed therein.

6. The intrauterine system according to claim 4, wherein the progestational steroid is progesterone and the copolymer has a vinyl ester content of 4 to 50% by weight and a melt index of 0.5 to 250 grams per ten minutes.

7. An intrauterine system for the controlled administration of an anti-fertility agent in an effective amount to the uterus of a warm-blooded mammal, said system comprising a flexible body of a copolymeric material containing an estrogenic steroid capable of diffusing through said copolymer, said body sized, shaped and adapted for insertion and retention for a prolonged period of time in the uterine cavity, and wherein said material comprises a copolymer of the following formula: ##STR18## and wherein the copolymer has a melt index of about 0.1 to 1000 grams per ten minutes, R is a member selected from the group consisting of alkyl of 2 to 7 carbon atoms and phenyl, m is (4 to 80)% by weight and n is (100-n)% by weight.

8. The intrauterine system according to claim 7, wherein the copolymer contains from 250 nanograms to 5 grams of estrogenic steroid, m has a frequency on the copolymeric backbone of 1/200 to 1/35, and the copolymer has a density of 0.920 to 1.25.

9. An intrauterine system for the controlled administration of an anti-fertility agent in an effective amount to the uterus of a warm-blooded mammal, said system comprising a copolymeric material surrounding a reservoir containing an anti-fertility estrogenic steroid capable of diffusing through the copolymer, said system further being sized, shaped and adapted for insertion and retention in the uterus for a prolonged period of time, and wherein said copolymer has the following formula: ##STR19## wherein R is a member selected from the group consisting of alkyl of 2 to 7 carbon atoms and phenyl, m is (4 to 80)% by weight, and which copolymer has a melt index of about 0.1 to 1000 grams per ten minutes is permeable to the passage of the steroid with the steroid dissolving in and passing through the ethylene-vinyl ester copolymer.

10. The intrauterine system according to claim 9, wherein m has a frequency on the copolymeric backbone of 1/200 to 1/35, the copolymer has a density of 0.920 to 1.25, and the reservoir is a container with from 250 nanograms to 5 grams of non-toxic, anti-fertility estrogenic steroid housed therein.

11. An intrauterine system for the controlled administration of drug in a therapuetically effective amount to the uterus of a warm-blooded mammal comprising a flexible body of a copolymeric material containing a drug capable of diffusing through the material in a therapeutically effective rate, said system sized, shaped and adapted for insertion and retention in the uterus for a prolonged period of time, and wherein said copolymer comprises an ethylene-vinyl alkyl substituted acetate having a vinyl alkyl acetate content of about 4 to 80% by weight, a melt index of about 0.01 to 1000 grams per ten minutes, and the alkyl group has 2 to 7 carbon atoms with the copolymer permeable to drug, which drug dissolves in and passes through the copolymer by diffusion.

12. An intrauterine system for the controlled administration of drug in a therapeutically effective amount to the uterus of a warm-blooded mammal comprising a copolymeric material surrounding a reservoir containing a drug capable of diffusing through the copolymer at an effective rate, said system sized, shaped and adapted for easy insertion and prolonged relation in the uterus, and wherein said copolymer comprises an ethylene-vinyl alkyl substituted acetate having a vinyl alkyl acetate content of about 4 to 80% by weight, a melt index of about 0.1 to 1000 grams per ten minutes and the alkyl group has 2 to 7 carbon atoms, with the copolymer permeable to drug which drug dissolves in and passes through the copolymer by diffusion.
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