Implantable controlled release device to deliver drugs directly to an internal portion of the body

• US 5,773,019 A
• Filed: 09/27/1995
• Issued: 06/30/1998
• Est. Priority Date: 09/27/1995
• Status: Expired due to Term

• Current Assignee: University Of Kentucky Research Foundation (University of Kentucky)
• Original Assignee: University Of Kentucky Research Foundation (University of Kentucky)
• Inventors: Ashton, Paul, Pearson, Paul A.
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US08/534,854
• Time in Patent Office: 1,007 Days
• Field of Search: 424/423, 424/427, 604/890.1, 604/892.1, 514/772.2, 514/772.3, 623/6
• US Class Current: 424/423
• 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
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61P 27/00 Drugs for disorders of the senses
• CPC Class Codes: A61P 27/02 Ophthalmic agents

Abstract

A simple and implantable sustained release drug delivery device with an inner core containing an effective amount of a low solubility agent covered by a non-bioerodible polymer coating layer that is permeable to the low solubility agent is disclosed. A method for treating a mammal to obtain a desired local or systemic physiological or pharmacological effect by surgically implanting such a sustained release drug delivery device into a mammal in need of treatment is also disclosed.

Claims

1. A sustained release drug delivery device comprising:

an inner core comprising an effective amount of a low solubility agent selected from the group consisting of immune response modifiers, corticosteroids, angiostatic steroids, anti-parasitic agents, anti-glaucoma agents, antibiotics, anti-sense compounds, differentiation modulators, anti-viral agents, anti-cancer agents, nonsteroidal anti-inflammatory agents, and low solubility codrugs; and

a non-bioerodible polymer coating layer, the polymer layer being permeable to the low solubility agent, wherein the polymer coating layer covers the inner core and is essentially non-release rate limiting.

2. The device according to claim 1, wherein the polymer coating layer holds the inner core in correct anatomic position and essentially prevents disintegration of the low solubility agent.

3. The device according to claim 2, wherein the polymer coating layer essentially reduces interaction between the low solubility agent in the inner core and proteinaceous components in surrounding bathing fluid to prevent enhanced release.

4. The device according to claim 1, wherein the low solubility agent is selected from the group consisting of cyclosporine A, trans-retinoic acid, cis-retinoic acid, other retinoids, and low solubility anti-sense compounds.

5. The device according to claim 1, wherein the polymer comprises a heat-treated polyvinyl alcohol.

6. The device according to claim 1, wherein the polymer is silicone.

7. The device according to claim 1, further comprising a means for attachment.

8. The device according to claim 4, wherein the means for attachment is selected from the group consisting of an extension of the polymer coating layer, a backing member or a support ring.

9. The device according to claim 1, wherein the inner core consists essentially of an effective amount of a low solubility agent or a pharmaceutically acceptable salt.

10. The device according to claim 1, wherein the polymer coating layer completely covers the inner core.

11. The device according to claim 1, consisting essentially of:

the inner core comprising an effective amount of the low solubility agent; and

the non-bioerodible polymer coating layer, the polymer layer being permeable to the low solubility agent, wherein the polymer coating layer covers the inner core.

12. A method for treating a mammalian organism to obtain a desired local or systemic physiological or pharmacological effect comprising:

surgically implanting a sustained release drug delivery device into a mammal in need of such treatment, the drug delivery device comprising;

an inner core comprising an effective amount of a low solubility agent selected from the group consisting of immune response modifiers, corticosteroids, angiostatic steroids, anti-parasitic agents, anti-glaucoma agents, antibiotics, anti-sense compounds, differentiation modulators, anti-viral agents, anti-cancer agents, nonsteroidal anti-inflammatory agents, and low solubility codrugs; and

a non-bioerodible polymer coating layer, the polymer layer being permeable to the low solubility agent, wherein the polymer coating layer covers the inner core and is essentially non-release rate limiting.

13. The device according to claim 12, wherein the polymer coating layer holds the inner core in correct anatomic position and essentially prevents disintegration of the low solubility agent.

14. The method according to claim 13, wherein the polymer coating layer essentially eliminates interaction between the low solubility agent in the inner core and proteinaceous components in surrounding bathing fluid to prevent enhanced release.

15. A method according to claim 12, wherein the device is surgically implanted within the eye.

16. A method according to claim 12, wherein the device is attached to an intraocular lens or a haptic extending from the intraocular lens.

17. A method according to claim 12, wherein the treatment is for uveitis, age related macular degeneration, and cytomegalovirus retinitis.

18. A method according to claim 12, wherein the polymer coating layer is essentially insoluble and inert in body fluids and compatible with eye tissues.

19. A method according to claim 12, wherein the agent is selected from the group consisting of cyclosporine A, trans-retinoic acid, cis-retinoic acid, other retinoids, and low solubility anti-sense compounds.

20. A method according to claim 12, wherein the sustained release device is surgically implanted at a desired location.

21. A method according to claim 12, wherein the sustained release device delivers an effective amount of the low solubility agent for at least 5 years.

22. A method according to claim 12, wherein the sustained release device delivers an effective amount of the low solubility agent for at least 10 years.