Selective administration of drug with ocular therapeutic system

• US 4,186,184 A
• Filed: 04/23/1979
• Issued: 01/29/1980
• Est. Priority Date: 12/27/1977
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Zaffaroni, Alejandro
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US06/032,498
• Time in Patent Office: 281 Days
• Field of Search: 128/260, 424/14-22, 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 9/0051 Ocular inserts, ocular implants

Abstract

A method for administering a drug to a preselected tissue compartment of the eye for advantageously controlling the concentration of drug in the tissue compartment is disclosed. The method comprises (1) placing an ocular therapeutic system in the eye, and (2) orienting the drug releasing portal of the system towards the preselected tissue compartment for controlled administration of drug thereto.

Claims

1. A method for administering drug to a preselected surface of the lid of an eye comprising the steps of:

(a) placing in the eye a therapeutic system comprising;

a drug, a drug delivery module sized, shaped and adapted as a platform for comfortable retention in the eye and for housing the drug, said module including a delivery portal defining a surface area of the module for releasing the drug from the system; and

,

(b) positioning the system in the eye by orienting the portal towards the preselected internal surface of the lid for effective administration of drug thereto.

2. The method for administering drug according to claim 1, wherein the drug is released by diffusion, osmosis, or bioerosion from the system.

3. A method for administering drug internally into the eye comprising the steps of:

(a) placing in the eye a therapeutic system comprising;

a drug, a drug delivery module sized, shaped and adapted as a platform for comfortable retention in the eye and for housing the drug, said module including a delivery portal defining a surface area of the module for releasing the drug from the system; and

,

(b) positioning the system in the eye by orienting the portal towards the globe of the eye for administering drug internally for effective administration of drug thereto.

4. A method for administering drug to a preselected surface of the lid of an eye comprising the steps of:

(a) placing in the eye a therapeutic system comprising;

a drug delivery module sized, shaped and adapted as a platform for comfortable retention in the eye, said module including (1) a reservoir, (2) a drug housed in the reservoir, and (3) a portal defining a single surface of the module for releasing drug from the system; and

,

(b) positioning the system in the eye by orienting the portal towards the preselected internal surface of the lid for effective administration of drug thereto.

5. The method for administering drug according to claim 4, wherein the preselected surface of the lid is the palpebral conjunctiva and the portal is in intimate contact with a preselected area thereof for selectively administering drug thereto.

6. The method for administering drug according to claim 4, wherein the portal releases drug into the tear film of the eye positioned between the portal and the internal surface of the lid, which film functions as a drug reservoir for transferring drug to the preselected internal surface of the lid.

7. The method for administering drug according to claim 4, wherein the portal is a rate controller for governing the rate of release of drug in a therapeutically effective amount from the system.

18. The method for administering a drug internally into the eye according to claim 4 wherein the drug is hydrocortisone, dexamethasone, fluocinolone, medrysone, prednisolone, fluoromethalone, bethethasone or triaminolone.

19. The method for administering a drug internally into the eye according to claim 4 wherein the drug is pilocarpine, physotigmine, eserine, carbachol, insulin, phospholine iodine, demecarium bromide, atropine, cyclopentolate, homatropine, scopolamine, tropicamide, eucatropine, hydroxyamphetamine, ephedrine, or epinephrine.

20. The method for administering a drug internally into the eye according to claim 4 wherein the drug is tetracycline, chlortetracycline, bacitacin, neomycin, polymyxin, gramicidin, cephalexin, oxytetracycline, chloramphenicol, kanamycin, gentamycin, erythromycin, penicillin, sulfamethiazole, sulfisoxazole, nitrofurazon, interferon, or idoxuridine.

21. The method for administering a drug to the surface of the lid of the eye according to claim 6 wherein the drug is hydrocortisone, dexamethasone, fluocinolone, merdysone, prednisolone, fluoromethalone, bethethasone, or triaminolone.

22. The method for administering a drug to the surface of the lid of the eye according to claim 6 wherein the drug is tetracycline, chlortetracycline, bacitracin, neomycin, polymyxin, gramicidin, cephalexin, oxytetracycline, chloramphenicol, kanamycin, gentamycin, erythromycin, penicillin, sulfonamide, sulfadrazine, sulfacetamide, sulfamethiazole, sulfisoxazole, nitrofurazone, interferon, or idoxuridine.

23. The method for administering a drug to the surface of the lid of the eye according to claim 6 wherein the drug is pilocarpine, physotigmine iodine, demecarium bromide, atropine, cyclopentoloate, homatropine, scopolamine, tropicamide, eucatropine, hydroxyamphetamine, ephedrine, or epiniphrine.

24. The method for administering drug according to claim 6 wherein the module is formed of a polymeric material which material is a reservoir for housing the drug and the portal is the single drug emitting surface of the system.

27. The method for administering drug into systemic circulation according to claim 23, wherein the module is formed of a pharmaceutically acceptable polymeric material and the reservoir is a container therein, with drug administered from the portal of the ocular therapeutic system with minimal lateral dispersion of drug from said system.

8. A method for administering a drug internally into the eye comprising the steps of:

(a) placing in the eye a therapeutic system comprising a drug delivery module sized, shaped and adapted as a platform for comfortable retention in the eye, said module including;

(1) a reservoir;

(2) a drug housed in the reservoir;

(3) a portal defining a single surface area of the module, said portal a means for releasing drug from the system;

(b) positioning the system in the eye by orienting the portal towards the globe of the eye for administering drug internally for effective administration of drug to produce a desired beneficial effect.

9. The method for administering drug internally to the eye according to claim 8, wherein the portal of the system is oriented towards the sclera of the globe of the eye for releasing drug thereto.

10. The method for administering drug internally to the eye according to claim 9, wherein the portal of the system is oriented towards the cornea of the globe of the eye for releasing drug thereto.

11. The method for administering drug internally to the eye according to claim 9, wherein the portal of the system is oriented towards the bulbar conjunctiva, and the system releases drug by means selected from the group consisting of diffusion, osmosis and bioerosion.

12. The method for administering drug internally to the eye according to claim 9, wherein the module is formed of a polymeric material which material is the reservoir housing drug, and the portal is a single drug emitting surface with the remaining surfaces of the system substantially impermeable to the passage of drug.

13. A method for admitting drug into the nasal pharyngeal duct which method consists essentially of:

(a) placing in the eye a therapeutic system comprising a drug delivery module, sized, shaped and adapted for comfortable retention in the eye, said module comprising;

(1) a reservoir;

(2) a drug housed in the reservoir;

(3) a portal defining a single surface area of the module, said portal a means for releasing drug from the reservoir; and

,

(b) positioning the system in the eye and orienting the drug delivery portal towards the palpebral conjunctiva for releasing drug into the tear film of the eye for passage through the punctum into the nasal pharyngeal duct.

14. The method for administering drug according to claim 13, wherein the module is formed of a polymeric material, which material is the reservoir housing drug, and the drug emitting portal is a surface of the module.

25. The method for administering drug internally into the eye according to claim 14 wherein the drug housed in the reservoir is pilocarpine, physotigmine, eserine, carbachol, insulin, atropine, homatropine, scopolamine, ephedrine, or epinephrine.

26. The method for administering drug internally to the eye according to claim 14 wherein the portal releases drug into the tear film of the eye positioned between the portal and the bulbar conjunction of the globe, which tear film serves as a drug reservoir for transferring drug internally to the eye and the portal functions as a controller means for regulating the rate of release of drug in a therapeutically effective amount from the system.

15. In a method for administering drug into systemic circulation comprising the steps of:

(a) inserting in the eye of a warm blooded animal a therapeutic system comprising a drug delivery module sized, shaped and adapted for prolonged retention in the eye, said module formed of a pharmaceutically acceptable polymeric material comprising;

(1) a reservoir;

(2) a drug confined in the reservoir;

(3) a portal defining a sole surface area of the material with the remaining surfaces of the system substantially impermeable to the passage of drug, said portal a means for emitting drug from the reservoir; and

,

(b) orienting the portal towards a preselected part of the eye capable of receiving a drug for administering the drug into systemic circulation for producing a beneficial response at a drug receiving tissue site distant from the eye.

16. In a method for administering drug into systemic circulation according to claim 15, wherein the module is a monolithic structure formed of a solid polymeric material with the drug confined therein.

17. In a method for administering drug into systemic circulation according to claim 15, wherein the portal is a rate controller means for controlling the rate of release of drug from the reservoir in a therapeutically effective amount over a prolonged period of time, and the drug is a systemically acting drug.