OCULAR INSERT

• US 3,618,604 A
• Filed: 06/09/1969
• Issued: 11/09/1971
• Est. Priority Date: 06/09/1969
• Status: Expired due to Term

• Current Assignee: Richard A. Ness
• Original Assignee: Richard A. Ness
• Inventors: Ness, Richard A.
• Primary Examiner(s): Michell, Robert W.
• Assistant Examiner(s): Dyer, R. P.
• Application Number:
  US04/831,761
• Time in Patent Office: 883 Days
• Field of Search: 128/260,296,156
• US Class Current: 604/294
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants

Abstract

Drug-dispensing ocular insert is comprised of a flexible body of polymeric material that is insoluble in tear liquid and has an imperforate surface. The polymeric material contains a drug which is dispensed to the eye in a therapeutically effective amount by diffusion through the polymeric material. The ocular insert is adapted for insertion in the cul-de-sac of the conjunctiva between the sclera of the eyeball and the lower lid, to be held in place against the eyeball by the pressure of the lid.

Claims

1. A medication-dispensing tablet for a human eyeball, said tablet comprising a reservoir of drug formulation confined within a flexible, imperforate and continuous-surfaced body of nonallergenic polymeric material which is insoluble in tear liquid, said body being formed of a drug-release rate-controlling polymer to continuously meter the flow of drug by diffusion from the reservoir to the eye at a controlled, predetermined and reproducible rate over a prolonged period of time, said body being adapted for insertion into the cul-de-sac of the conjunctiva between the sclera of the eyeball and eyelid, to be held in place against the eyeball by the pressure of the lid, and said body having a marginal outline and cross section adapted to assume essentially the configuration of the scleral curvature;

said drug being capable of transport through the unbroken walls of said body by diffusion and said body being so constructed and arranged that, when applied to the eyeball, to dispense said drug thereto, drug leaving said body by diffusion is transported to the eyeball by the flow of tears and by the blinking action of the eyelids.

2. The medication-dispensing tablet as defined by claim 1, wherein the reservoir of drug formulation is comprised of a sealed container with walls of said polymeric material and said drug is contained in an interior chamber thereof.

3. The medication-dispensing tablet as defined by claim 2, wherein said polymeric material is selected from the group consisting of plasticized or unplasticized polyvinyl chloride, plasticized nylon, unplasticized soft nylon, plasticized polyethylene terephthalate, silicone rubber, hydrophilic hydrogel of an ester of acrylic or methacrylic acid, modified collagen, cross-linked hydrophilic polyether gel, cross-linked polyvinyl alcohol, and cross-linked partially hydrolyzed polyvinyl acetate.

4. The medication-dispensing tablet as defined by claim 3, wherein said polymeric material is silicone rubber.

5. The medication-dispensing tablet as defined by claim 3, wherein said polymeric material is a hydrophilic hydrogel of an ester of acrylic or methacrylic acid.

6. The medication-dispensing tablet as defined by claim 1, wherein the reservoir of drug formulation is comprised of a matrix of the drug-release rate-controlling polymeric material, said matrix having the drug distributed therethrough.

7. The medication-dispensing tablet as defined by claim 1, wherein said polymeric material is selected from the group consisting of plasticized unplasticized polyvinyl chloride, plasticized nylon, unplasticized soft nylon, plasticized polyethylene terephthalate, silicone rubber, hydrophilic hydrogel of an ester of acrylic or methacrylic acid, modified collagen, cross-linked hydrophilic polyether gel, cross-linked polyvinyl alcohol, and cross-linked partially hydrolyzed polyvinyl acetate.

8. The medication-dispensing tablet as defined by claim 7, wherein said polymeric material is silicone rubber.

9. The medication-dispensing tablet as defined by claim 7, wherein said polymeric material is a hydrophilic hydrogel of an ester of acrylic or methacrylic acid.

10. The medication-dispensing tablet as defined by claim 1, wherein said drug is an ophthalmic drug.

11. The medication-dispensing tablet as defined by claim 1, wherein said drug is a systemically active drug which will pass through the eye to the bloodstream and produce a pharmacologic response at a site remote from the eye.

12. The medication-dispensing tablet as defined by claim 1, wherein said drug is a systemically active drug which will pass through the tissue surrounding the eye to the bloodstream and produce a pharmacologic response at a site remote from the eye.

13. The medication-dispensing tablet as defined by claim 1, wherein from 1 microgram to 1 milligram of drug is incorporated in said tablet.

14. The medication-dispensing tablet as defined by claim 1, wherein same is circular in cross section and tapered at its ends.

15. The medication-dispensing tablet as defined by claim 1, wherein same is ellipsoidal in cross section and tapered at its ends.

16. The medication-dispensing tablet as defined by claim 1, wherein same ranges from 4 to 20 millimeters in length, 1 to 12 millimeters in width, and 0.1 to 1 millimeter in thickness.

17. The medication-dispensing tablet as defined by claim 1, wherein the drug is chloramphenicol and the polymeric material is polyethylene terephthalate.

18. The medication-dispensing tablet as defined by claim 1, wherein the drug is promethazine trichloroacetate and the polymeric material is polyvinyl chloride. 19 The medication-dispensing tablet as defined by claim 1, wherein the drug is chloramphenicol and the polymeric material is polydimethylsiloxane rubber.

20. The medication-dispensing tablet as defined by claim 1, wherein the drug is a member selected from the group consisting of pilocarpine and pilocarpine perfluorobutyrate and the polymeric material is polyvinyl chloride.

21. The medication-dispensing tablet as defined by claim 1, wherein the drug is dexamethasone and the polymeric material is nylon-66.