Ocular therapeutic system manufactured from copolymer

• US 4,052,505 A
• Filed: 07/15/1976
• Issued: 10/04/1977
• Est. Priority Date: 05/30/1975
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Hussain, Anwar, Higuchi, Takeru
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US05/705,479
• Time in Patent Office: 446 Days
• Field of Search: 128/260, 424/14, 424/19-22, 424/28
• US Class Current: 424/427
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• 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

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. An ocular therapeutic system for the controlled release of drug comprising a flexible body formed of a polymeric material permeable to the passage of drug by diffusion and containing a drug capable of diffusing through the material at a therapeutically effective rate, the body shaped, sized and adapted for comfortable insertion and retention in the cul-de-sac of the conjuctiva between the sclera of the eyeball and the lid to be held in place against the eyeball by the pressure of the lid, and wherein said polymeric material comprises 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 ten minutes.

2. The ocular system according to claim 1 wherein the drug is an ophthalmic drug.

3. The ocular system according to claim 1 wherein the drug is pilocarpine.

4. An ocular therapeutic system for the controlled release of drug comprising a flexible body formed of a polymeric material permeable to the passage of drug by diffusion and surrounding a drug capable of diffusing through the material at a therapeutically effective rate, the body shaped, sized and adapted for comfortable insertion and retention in the cul-de-sac of the conjunctiva between the sclera of the eyeball and the lid, to be held in place against the eyeball by the pressure of the lid, and wherein said polymeric material comprises 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 ten minutes.

5. The ocular system according to claim 4 wherein the body is a container with drug contained therein.

6. The ocular system according to claim 4 wherein the drug is an ophthalmic drug.

7. The ocular system according to claim 4 wherein the drug is pilocarpine.

8. An ocular therapeutic system for the controlled and continuous administration of drug to the eye of a warm blooded animal comprising a body formed of a polymeric material permeable to the passage of drug by diffusion and surrounding a drug capable of diffusing through the material at a therapeutically effective rate, the body shaped, adapted and sized with a length of 4 to 20 mm, a width of 0.1 to 12 mm and a thickness of 0.1 to 4 mm for insertion and retention in the eye, and wherein the material comprises an ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% by weight and melt index of about 0.1 to 1000 grams per ten minutes, with the copolymer when the system is in the eye administering drug to the eye at a controlled rate over a prolonged period of time.

9. The ocular system according to claim 8 wherein the body is a container and the drug is contained therein.

10. The ocular system according to claim 8 wherein the copolymer surrounds a reservoir containing an ophthalmic drug.

11. The ocular system according to claim 8 wherein the drug is pilocarpine.

12. An ocular therapeutic system for the controlled administration of drug to the eye comprising a body formed of a drug release rate controlling ethylene-vinyl acetate copolymer permeable to the passage of drug by diffusion and containing a dosage amount of a drug capable of diffusing through the copolymer, said body shaped, adapted and sized for comfortable insertion and placement in the eye, and wherein the body when in the eye administers a therapeutically effective amount of drug by the drug dissolving in and passing through the copolymer at a controlled rate over a prolonged period of time.

13. The ocular system according to claim 12 wherein the copolymer has a vinyl acetate content of 4 to 50% by weight, a melt index of 0.5 to 250 grams per 10 minutes, a density of 0.920 to 0.980, and a frequency of acetoxy groups on the ethylene backbone of 1/150 to 1/8.

14. The ocular system according to claim 12 wherein the drug is an ophthalmic drug.

15. The ocular system according to claim 12 wherein the drug is pilocarpine.

16. An ocular therapeutic system for administering drug to the eye comprising a body shaped and sized for comfortable insertion and retention in the eye, the body formed of a drug release rate controlling ethylene-vinyl acetate copolymer having a vinyl acetate content of 4 to 80% by weight, permeable to the passage of drug by diffusion and surrounding a drug capable of diffusing therethrough, and wherein said body when in the eye administers a therapeutically effective amount of drug by passage through the copolymer at a controlled rate over a prolonged period of time.

17. The ocular system for administering drug to the eye according to claim 16 wherein the copolymer has a melt index of 0.1 to 1000 grams per 10 minutes and the drug is an ophthalmic drug.

18. The ocular system according to claim 16 wherein the body is a container with the drug contained in the reservoir thereof.

19. The ocular system according to claim 16 wherein the drug is pilocarpine.