Drug-delivery device comprising certain polymeric materials for controlled release of drug

• US 4,069,307 A
• Filed: 05/30/1975
• Issued: 01/17/1978
• Est. Priority Date: 10/01/1970
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Higuchi, Takeru, Hussain, Anwar
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US05/582,353
• Time in Patent Office: 963 Days
• Field of Search: 128/260, 424/14, 424/16, 424/19-22, 424/28, 424/32, 424/33, 424/48, 426/3
• US Class Current: 424/432
• CPC Class Codes: A61F 6/14 intra-uterine type
• CPC Class Codes: A61F 6/142 Wirelike structures, e.g. loops, rings, spirals
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• 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 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
• 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

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.

Claims

1. A shape retaining implant for releasing drug formed of a copolymer compatible with body tissue, the improvement wherein the implant is formed of a matrix of ethylene-vinyl acetate copolymer containing drug, said drug mixed throughout the copolymer which has a vinyl acetate content of 4 to 80% by weight, a melt index of about 0.1 to 1000 grams per ten minutes, is permeable to the passage of the drug by diffusion, and capable of releasing a therapeutically effective amount of drug to body tissue at a predetermined and controlled rate over a prolonged period of time.

2. The implant of claim 1, wherein said ethylene-vinyl acetate copolymer has a vinyl acetate content of about 4 to 50% by weight and a melt index of about 0.5 to 100 grams per 10 minutes.

3. The implant of claim 1, wherein said ethylene-vinyl acetate copolymer has a vinyl acetate content of about 4 to 40% by weight and a melt index of about 0.15 to 25 grams per 10 minutes.

4. The implant of claim 1, wherein the ethylene-vinyl acetate copolymer has a vinyl acetate content of 4 to 50% and a frequency of acetoxy groups on the polyethylene backbone of 1/150 to 1.8.

5. The implant of claim 1, wherein the ethylene-vinyl acetate copolymer has a density of about 0.920 to 0.980 and a vinyl acetate content of 4 to 50%.

6. The implant of claim 1, wherein the copolymer contains from about 250 nanograms to 5 grams of drug capable of diffusion through said polymeric material in a therapeutically effective amount over a prolonged period of time.

7. The implant of claim 1, wherein the copolymer is a cylinder shaped body.

8. The implant of claim 1, wherein the copolymer contains diethylstilbestrol that is released in a therapeutically effective amount over a prolonged period of time.

9. A method for administering a pharmaceutically acceptable drug to an animal which method comprises placing an implant shaped, sized and adapted for placement in the animal and formed of a non-toxic copolymer material, the improvement wherein the implant is a matrix of ethylene-vinyl acetate copolymer containing a dosage unit amount of drug selected from the group consisting of locally acting and systemically acting drugs mixed therethrough and capable of dissolving in and diffusing through the copolymer at a controlled rate over a prolonged period of time, said copolymer having a vinyl acetate content of 4 to 80% by weight, a melt index of 0.1 to 1000 grams per 10 minutes and permeable to the passage of drug which drug passes through the ethylene-vinyl acetate copolymer in a therapeutically effective amount to produce the local or systemic action in the animal.