Bioerodible ocular device

• US 3,960,150 A
• Filed: 09/15/1975
• Issued: 06/01/1976
• Est. Priority Date: 09/09/1971
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Shell, John W., Hussain, Anwar A., Higuchi, Takeru
• Primary Examiner(s): Medbery, Aldrich F.
• Application Number:
  US05/613,384
• Time in Patent Office: 260 Days
• Field of Search: 128/260, 128/268, 128/271
• US Class Current: 424/428
• 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

An ocular insert for the continuous controlled administration of a predetermined therapeutically effective dosage of drug to the eye over a prolonged period of time. The device meters the flow of drug by means of a drug release rate controlling material. The insert bioerodes in the environment of the eye concurrently with the dispensing or at a point in time after the dispensing of the therapeutically desired amount of drug.

Claims

1. A bioerodible ocular device for the controlled continuous administration of a predetermined dosage of drug to the eye, comprising a body of hydrophobic bioerodible drug release rate controlling material containing a drug confined therein, the body being of an initial shape which is adapted for insertion in the sac of the eye bounded by the surfaces of the bulbar conjunctiva of the sclera of the eyeball and the palpebral conjunctiva of the lid and being further adapted for retention in said sac during said administration, the body continuously metering the administration of a therapeutically effective amount of drug to the eye at a controlled rate for at least 8 hours by permeation control release, erosion control release or a combination thereof and wherein the body bioerodes in the environment of the eye concurrently with the administration or at a point in time after the administration of the drug.

2. The ocular device defined by claim 1 wherein the prolonged period of time is an interval of from 8 hours to 30 days.

3. The ocular device defined in claim 2 wherein the body bioerodes in the eye over a prolonged period of time in response to the environment in the eye by a process of solubilization.

4. The ocular device defined by claim 2 wherein the body bioerodes in the eye over a prolonged period of time in response to the environment in the eye by a process of hydrolysis, oxidation, or reduction.

5. The ocular device defined by claim 2 wherein the body bioerodes in the eye over a prolonged period of time in response to the environment in the eye by a process of enzymatic cleavage.

6. The ocular device defined by claim 5 wherein the device contains an added enzyme to regulate the bioerosion rate of the device.

7. The ocular device defined by claim 2 wherein the body bioerodes in the eye over a prolonged period of time in response to the environment in the eye by a process of ion exchange or displacement.

8. The ocular device defined by claim 2 wherein the continuous dispensing of a metered amount of drug from the body to the eye is effected primarily through an erosion control release mechanism.

9. The ocular device defined by claim 2 wherein the body material bioerodes in the eye at a rate of from 0.1 milligrams per day to 15 milligrams per day.

10. The ocular device defined by claim 2 wherein the device contains an added agent to regulate the bioerosion rate selected from the group consisting of binding agents and disintegrating agents.

11. The ocular device defined by claim 2 wherein the initial configuration of the body is in the shape of a donut adapted for insertion and retention surrounding the corneal area of the eye.

12. The ocular device defined by claim 2 wherein the drug is a member selected from the group consisting of epinephrine, pilocarpine, hydrocortisone, idoxuridine, tetracyclene, polymixin, gentamycin, neomycin, dexamethasone, and pharmaceutically acceptable derivatives of these drugs.

13. The ocular device defined by claim 2 wherein the drug release rate controlling material is a polyester of the general formula:

##EQU6## and mixtures thereof, wherein;

W is a radical of the formula -CH₂ --;

or ##EQU7## Y has a value such that the molecular weight of the polymer is from about 4,000 to 100,000.

14. The ocular device defined by claim 1 wherein the prolonged period of time is an interval of from 1 to 8 days.