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US5773019A Expired / Lapsed US ⏱️ 0.0 years remaining

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

Assignee: University of Kentucky Research Foundation
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Filing: 1995-09-27
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Granted: 1998-06-30
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Expires: 2015-09-27
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Abstract

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.

Inventors

  • 👤 Paul Ashton
  • 👤 Paul A. Pearson

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-27 18:31
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0012; A61K9/0048; A61K9/0051; A61F; A61F9/00; A61F9/0008; A61F9/0017; A61M; A61M31/00; A61M31/002; A61P; A61P27/00; A61P27/02

Claims Analysis

Total Claims: 24
Claim 1
Independent Claim 82 words
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.
Claim 2
Dependent Claim 82 words
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.
Claim 3
Dependent Claim 28 words
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.
Claim 4
Dependent Claim 34 words
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.
Claim 5
Dependent Claim 31 words
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.
Claim 6
Dependent Claim 14 words
The device according to claim 1, wherein the polymer comprises a heat-treated polyvinyl alcohol.
Claim 7
Dependent Claim 11 words
The device according to claim 1, wherein the polymer is silicone.
Claim 8
Dependent Claim 12 words
The device according to claim 1, further comprising a means for attachment.
Claim 9
Dependent Claim 32 words
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.
Claim 10
Dependent Claim 26 words
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.
Claim 11
Dependent Claim 16 words
The device according to claim 1, wherein the polymer coating layer completely covers the inner core.
Claim 12
Dependent Claim 46 words
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.
Claim 13
Independent Claim 115 words
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.
Claim 14
Independent Claim 115 words
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.
Claim 15
Dependent Claim 28 words
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.
Claim 16
Dependent Claim 34 words
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.
Claim 17
Dependent Claim 15 words
A method according to claim 12, wherein the device is surgically implanted within the eye.
Claim 18
Dependent Claim 23 words
A method according to claim 12, wherein the device is attached to an intraocular lens or a haptic extending from the intraocular lens.
Claim 19
Dependent Claim 19 words
A method according to claim 12, wherein the treatment is for uveitis, age related macular degeneration, and cytomegalovirus retinitis.
Claim 20
Dependent Claim 24 words
A method according to claim 12, wherein the polymer coating layer is essentially insoluble and inert in body fluids and compatible with eye tissues.
Claim 21
Dependent Claim 29 words
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.
Claim 22
Dependent Claim 18 words
A method according to claim 12, wherein the sustained release device is surgically implanted at a desired location.
Claim 23
Dependent Claim 25 words
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.
Claim 24
Dependent Claim 25 words
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.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2001-06-29 2001-12-29 2002-06-30 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2005-06-29 2005-12-29 2006-06-30 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2009-06-29 2009-12-29 2010-06-30 $7700.00 Window Closed / Lapsed

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