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Details for Patent: 3,896,819

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Details for Patent: 3,896,819

Title: IUD having a replenishing drug reservoir
Abstract:A drug delivery device for administering a drug at a controlled rate for a prolonged period of time to produce a local or systemic physiological or pharmacological effect is comprised of a wall surrounding a reservoir containing a drug. The reservoir is formed of a drug carrier permeable to the passage of the drug and in which the drug has limited solubility. The drug carrier is liquid and contains both dissolved and undissolved replacement drug. The wall is formed in at least a part of a drug release rate controlling material also permeable to the passage of the drug, but the rate of passage of the drug through the wall is lower than the rate passage of the drug through the drug carrier so that drug release by the wall is the drug release rate controlling step for releasing drug from the drug delivery device.
Inventor(s): Zaffaroni; Alejandro (Atherton, CA), Alza Corporation (Palo Alto, CA)
Assignee:
Filing Date:Sep 30, 1971
Application Number:05/185,208
Claims:1. An intrauterine device comprising means having a configuration exerting an anti-fertility effect when placed in the uterine cavity and drug delivery means for providing programmed delivery of drug at a rate of delivery characterized by substantially zero order time dependence for a prolonged period of at least one month, said drug delivery means comprising:

a. reservoir comprising dissolved drug and undissolved replacement drug in a liquid carrier material having limited solubility for the drug and permeable to the passage of the drug, the replacement drug being present in an amount sufficient to maintain the dissolved drug in an amount substantially equal to the amount of dissolved drug originally present in the carrier material during said prolonged period; and

b. a shaped wall surrounding said reservoir, said shaped wall being capable of maintaining its integrity during said prolonged period and being formed at least in part of a substantially homogeneous drug release rate controlling material permeable to the passage of the drug but having a lower permeability to the drug than the permeability thereto of the liquid carrier material;

said means having a configuration exerting an antifertility effect comprising the outer configuration of said shaped wall; said shaped wall being of such size and shape to contact the sides of the uterus when said device is placed in the uterine cavity;

said device when placed in the uterine cavity continuously releases drug from the reservoir at a controlled contraceptively effective rate by metered passage through the wall, the dissolved drug so released being replaced by the continuous dissolving of replacement drug in the carrier material.

2. An intrauterine device in accordance with claim 1 wherein the wall is permeable to the passage of drug by diffusion.

3. An intrauterine device in accordance with claim 1 wherein the drug release rate controlling material is polymeric in nature.

4. An intrauterine device in accordance with claim 1 wherein the drug release rate controlling material is ethylene-vinyl acetate copolymer.

5. An intrauterine device in accordance with claim 1 wherein the drug is soluble in the liquid carrier material in an amount of one part of the drug to about 10 to 15,000 parts of the liquid carrier material at 25.degree.C.

6. An intrauterine device in accordance with claim 1 wherein the drug is soluble in the liquid carrier material in an amount of one part of the drug to 100 to 1000 parts of the liquid carrier material at 25.degree.C.

7. An intrauterine device in accordance with claim 1 wherein the permeability of the liquid carrier material to drug is from 100 to two times the permeability of the release rate controlling material to drug.

8. An intrauterine device in accordance with claim 1 wherein the drug is a progestational agent, an estrogenic agent or a mixture thereof.

9. An intrauterine device in accordance with claim 1 wherein the drug is progesterone and the drug release rate controlling material is ethylene-vinyl acetate copolymer.

10. An intrauterine device in accordance with claim 9 wherein the liquid carrier is an oil.

11. An intrauterine device in accordance with claim 9 wherein the liquid carrier is silicone oil.

12. An intrauterine device in accordance with claim 11 wherein said prolonged period of time is one to three years and the progesterone is present in an amount sufficient to release from 10 to 100 .mu.g per day during said prolonged period.
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