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

• US 6,001,386 A
• Filed: 04/14/1998
• Issued: 12/14/1999
• 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: Pearson, Paul A., Ashton, Paul
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US09/059,448
• Time in Patent Office: 609 Days
• Field of Search: 424/423, 424/424, 424/427, 514/772.2, 514/772.3, 604/890.1, 604/892.1, 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 an agent having a solubility less than about 10 μ

gml; and

a polymer coating layer, the polymer layer being permeable to the agent, wherein the polymer coating layer completely covers the inner core.

2. The device according to claim 1, wherein the solubility of the agent is about 0.01 μ

g/ml-about 0.001 μ

g/ml.

3. The device according to claim 1, wherein the solubility of the agent is about 0.001 μ

g/ml-about 0.0001 μ

g/ml.

4. The device according to claim 1, wherein the solubility of the agent is less than about 0.0001 μ

g/ml.

5. The device according to claim 1, wherein the agent has low solubility.

6. The device according to claim 1, wherein the agent is slightly soluble.

7. The device according to claim 1, wherein the agent is very slightly soluble.

8. The device according to claim 1, wherein the agent is practically insoluble or insoluble.

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

administering a sustained release drug delivery device to a mammalian organism in need of such treatment, the drug delivery device comprising;

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

a polymer coating layer, the polymer layer being permeable to the low solubility agent, wherein the polymer coating layer completely covers the inner core.

10. The method according to claim 9, wherein the solubility of the agent is about 0.01 μ

g/ml-about 0.001 μ

g/ml.

11. The method according to claim 9, wherein the solubility of the agent is about 0.001 μ

g/ml-about 0.0001 μ

g/ml.

12. The method according to claim 9, wherein the solubility of the agent is less than about 0.000 μ

g/ml.

13. The method according to claim 9, wherein the agent has low solubility.

14. The method according to claim 9, wherein the agent is slightly soluble.

15. The method according to claim 9, wherein the agent is very slightly soluble.

16. The method according to claim 9, wherein the agent is practically insoluble or insoluble.

17. A sustained release drug delivery device comprising:

an inner core comprising an effective amount of fluocinolone acetonide;

and a polymer coating layer, the polymer layer being permeable to the fluocinolone acetonide, wherein the polymer coating layer completely covers the inner core.

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

administering a sustained release drug delivery device to a mammalian organism in need of such treatment, the drug delivery device comprising;

an inner core comprising an effective amount of fluocinolone acetonide; and

a polymer coating layer, the polymer layer being permeable to the fluocinolone acetonide, wherein the polymer coating layer completely covers the inner core.