Drug delivery device

• US 3,967,618 A
• Filed: 03/06/1975
• Issued: 07/06/1976
• Est. Priority Date: 04/01/1969
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Zaffaroni, Alejandro
• Primary Examiner(s): Medbery, Aldrich F.
• Application Number:
  US05/555,840
• Time in Patent Office: 488 Days
• Field of Search: 128/130, 128/260, 128/268, 128/272, 424/19, 424/20, 424/21
• US Class Current: 128/833
• CPC Class Codes: A61F 6/144 with T-configuration
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0036 Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
• CPC Class Codes: A61K 9/0039 Devices retained in the uterus for a prolonged period, e.g. intrauterine devices for contraception
• CPC Class Codes: A61K 9/0092 Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes
• CPC Class Codes: A61L 15/58 Adhesives
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

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.

Claims

1. A method of interfering with the reproductive process of a female mammal comprising continuously administering a contraceptive agent within the uterine cavity of said female over a prolonged period of time by:

A. inserting into the uterine cavity an intrauterine device comprising;

a. a reservoir comprising an agent in a liquid carrier material permeable to the passage of the agent, said agent comprising a dissolved portion and an undissolved portion that serves to replace said dissolved portion, the reservoir being confined within;

b. an enveloping shaped membrane comprised of a biologically acceptable material insoluble in mammalian body fluid, capable of keeping its integrity during said prolonged period and formed at least in part of a material permeable by diffusion to passage of said agent at a rate which is lower than the rate of permeability of said agent through said carrier;

B. releasing said agent from said reservoir into the uterine cavity at a controlled, continuous, contraceptively effective rate by diffusional passage through said shaped membrane; and

;

C. continuously replacing the dissolved agent released from the reservoir by continuously dissolving said undissolved agent in the carrier material.

2. The method of claim 1 wherein the rate of release of said dissolved agent through said membrane is less than the rate of clearance of released agent from the external surface of the device.

3. The method of claim 1 wherein said agent is a progestational or estrogenic agent.

4. The method of claim 1 wherein said membrane is comprised of ethylene-vinyl acetate copolymer.

5. The method of claim 1 wherein said controlled and continuous rate is substantially independent of time.

6. The method of claim 4 wherein said prolonged period of time is one to three years and the agent is progesterone present in an amount sufficient to provide a dosage regimen for an adult female at a release rate of from 10 to 200 μ

g per day during said prolonged period of time.

7. The method of claim 1 wherein the undissolved agent is present in an amount sufficient to maintain the dissolved agent in an amount substantially equal to the amount of dissolved agent originally present in the carrier material over said prolonged period and said continuous replacement maintains the amount of dissolved agent at said originally present amount over said prolonged period.