Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof

• US 9,849,085 B2
• Filed: 10/22/2015
• Issued: 12/26/2017
• Est. Priority Date: 04/26/2000
• Status: Expired due to Fees

• Current Assignee: EyePoint Pharmaceuticals, Inc.
• Original Assignee: pSivida US, Inc
• Inventors: Guo, Hong, Ashton, Paul
• Primary Examiner(s): Vanhorn, Abigail
• Application Number:
  US14/919,962
• Publication Number:
  US 20160038412A1
• Time in Patent Office: 796 Days
• Field of Search: None
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/0092 Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes
• CPC Class Codes: A61K 9/20 Pills, tablets, discs, rods A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095
• CPC Class Codes: A61K 9/5089 Processes
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 9/12 Antihypertensives
• CPC Class Codes: Y10T 29/49888 Subsequently coating

Abstract

A method and device for treating a mammalian organism to obtain a desired local or systemic physiological or pharmacological effect is provided. The method includes administering a sustained release drug delivery system to a mammalian organism in need of such treatment at an area wherein release of an effective agent is desired and allowing the effective agent to pass through the device in a controlled manner. The device includes an inner core or reservoir including the effective agent, an impermeable tube which encloses portions of the reservoir, and a permeable member at an end of the tube.

Claims

1. A method for treating a mammal to obtain a desired local or systemic physiological or pharmacological effect, comprising administering to the mammal a sustained release drug delivery system, wherein:

(i) the system comprises;

a drug reservoir comprising a therapeutically effective amount of an agent;

an inner tube covering at least a portion of the drug reservoir, wherein the inner tube has a first open end and a second open end, the diameter of the inner tube is not more than 3 millimeters, and the inner tube is dimensionally stable and capable of supporting its own weight; and

an outer layer, covering a portion of the inner tube, wherein the outer layer is permeable to the passage of the agent; and

(ii) upon administering the system, the agent is released through at least one of the first open end and second open end.

2. The method of claim 1, wherein the inner tube is impermeable to the passage of the agent.

3. The method of claim 1, wherein the inner tube is permeable to the passage of the agent.

4. The method of claim 1, wherein the inner tube comprises a polymer or a metal.

5. The method of claim 4, wherein the inner tube comprises gold, platinum, or stainless steel.

6. The method of claim 1, wherein the inner tube or outer layer comprises

ethyl vinyl acetate, polyvinyl acetate, cross-linked polyvinyl alcohol, cross-linked polyvinyl butyrate, ethylene ethylacrylate copolymer, polyethyl hexylacrylate, polyvinyl chloride, polyvinyl acetals, plasticized ethylene vinylacetate copolymer, polyvinyl alcohol, polyvinyl acetate, ethylene vinylchloride copolymer, polyvinyl esters, polyvinylbutyrate, polyvinylformal, polyamides, polymethylmethacrylate, polybutyl methacrylate, plasticized polyvinyl chloride, plasticized nylon, plasticized soft nylon, plasticized polyethylene terephthalate, natural rubber, polyisoprene, polyisobutylene, polybutadiene, polyethylene, polytetrafluoroethylene, polyvinylidene chloride, polyacrylonitrile, cross-linked polyvinylpyrrolidone, polytrifluorochloroethylene, chlorinated polyethylene, poly(1,4′

-isopropylidene diphenylene carbonate), vinylidene chloride, acrylonitrile copolymer, vinyl chloride-diethyl fumarate copolymer, silicone rubbers, ethylene-propylene rubber, silicone-carbonate copolymers, vinylidene chloride-vinyl chloride copolymer, vinyl chloride-acrylonitrile copolymer, or vinylidene chloride-acrylonitrile copolymer.

7. The method of claim 6, wherein the outer layer comprises polyvinyl alcohol.

8. The method of claim 1, wherein the length of the tube is not more than 7 millimeters.

9. The method of claim 1, wherein the agent is a corticosteroid.

10. The method of claim 9, wherein the corticosteroid is fluocinolone acetonide.

11. The method of claim 10, wherein administering comprises inserting the system into the mammal.

12. The method of claim 11, wherein inserting comprises injecting the system at a desired location.

13. The method of claim 12, wherein the location is selected from the vitreous of the eye, under the retina, and onto the sclera.

14. The method of claim 11, comprising inserting the system into the vitreous of the eye.

15. The method of claim 14, wherein inserting comprises injecting the system into the vitreous of the eye.

16. The method of claim 1, wherein the mammal is a human.

17. A method for treating a human to obtain a desired local or systemic physiological or pharmacological effect, comprising administering to the human a sustained release drug delivery system, wherein:

(i) the system comprises;

a drug reservoir comprising a therapeutically effective amount of an agent;

an inner tube covering at least a portion of the drug reservoir, wherein the inner tube has a first open end and a second open end, the diameter of the inner tube is not more than 3 millimeters, the length of the inner tube is not more than 7 millimeters, and the inner tube is dimensionally stable and capable of supporting its own weight; and

an outer layer, covering a portion of the inner tube, wherein the outer layer is permeable to the passage of the agent;

(ii) administering comprises inserting the system into the vitreous of the eye; and

(iii) upon administering the system, the agent is released through at least one of the first open end and second open end.

18. The method of claim 17, wherein the agent is a corticosteroid.

19. The method of claim 18, wherein the corticosteroid is fluocinolone acetonide.

20. The method of claim 17, wherein inserting comprises injecting the system into the vitreous of the eye.