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|Title:||Novel drug delivery device|
|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 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)|
|Assignee:||Alza Corporation (Palo Alto, CA)|
|Filing Date:||Mar 03, 1975|
|Claims:||1. A delivery device for the controlled and continuous administration of drug to a body site over a prolonged period of time, said device comprising: |
a. a means for containing and releasing the drug at a controlled rate comprising a reservoir containing a dissolved drug portion and an undissolved replacement drug portion in a liquid carrier material permeable to the passage of the drug therethrough, said drug having limited solubility in said liquid carrier material; the replacement drug portion being present in an amount in excess of its solubility in the carrier material and in an amount sufficient to maintain the amount of the dissolved drug portion substantially constant during said prolonged period of time, said means further comprising:
b. a shaped wall that surrounds the reservoir and is characterized by being insoluble in body fluid, maintaining its integrity during said prolonged period of time, and by being formed at least in part of a microporous polymer housing in its micropores a drug release rate controlling medium permeable to the passage of the drug but having a lower permeability to the drug than the permeability of the liquid carrier material to the drug; so that the device when placed at the body site, continuously releases drug from the reservoir of the body site at a physiologically or pharmacologically effective controlled rate by metered passage through the medium, the dissolved drug so released being replaced by the continuous dissolving of replacement drug in the carrier material so as to substantially maintain the amount of dissolved drug in the reservoir substantially constant during said prolonged time period.
2. A delivery device in accordance with claim 1 wherein the cumulative amount of dissolved drug and undissolved drug contained in the liquid carrier material is in an amount to provide a complete dosage regimen for a living organism for a period of time in an amount of at least 1 month.
3. A delivery device in accordance with claim 1 wherein the drug is soluble in the liquid carrier material in an amount of one part of drug to about 10 to 15,000 parts of liquid carrier material at 25.degree. C.
4. A delivery device in accordance with claim 1 wherein the permeability of the liquid carrier material to drug is from about 100:1 to 2:1 times greater than the permeability of the medium in the micropores of the wall.
5. A delivery device in accordance with claim 1 wherein the drug release rate controlling medium material is permeable to the passage of drug by diffusion.
6. A delivery device in accordance with claim 1 wherein the rate of controlled and continuous release from the device is substantially independent of time.
7. A delivery device in accordance with claim 1 wherein the prolonged period of time is at least a period of 1 month.
8. A delivery device in accordance with claim 1 wherein the drug is metered in vivo from the device to an internal receptor site of a body cavity of a mammal.
9. A delivery device in accordance with claim 1 wherein the permeability of said medium to said drug is such that the rate of flow of drug from the reservoir is less than the rate of clearance of migrated drug from the external surface of the device when the device is in contact with body tissues or fluids.
10. A delivery device in accordance with claim 1 wherein the device is an intrauterine device said environment of use being the uterus of a female mammal.
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