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Coating compositions for bioactive agents

a bioactive agent and coating composition technology, applied in the field of coating compositions for bioactive agents, can solve the problems of ischemic injury, stroke or myocardial infarction, sudden closure of the vessel, and numerous physiological complications

Inactive Publication Date: 2005-11-03
SURMODICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The coating composition effectively controls the release of bioactive agents, maintains durability and biocompatibility, and prevents delamination, enhancing the performance and longevity of medical devices by providing a stable and effective drug delivery system.

Problems solved by technology

Many individuals suffer from circulatory disease caused by a progressive blockage of the blood vessels, which often leads to hypertension, ischemic injury, stroke, or myocardial infarction.
A limitation associated with PTCA is the abrupt closure of the vessel which can occur soon after angioplasty.
. . ), after placement in the body, can give rise to numerous physiological complications.
Some of these complications include: increased risk of infection; initiation of a foreign body response resulting in inflammation and fibrous encapsulation; and initiation of a detrimental wound healing response resulting in hyperplasia and restenosis.
These problems have been particularly acute with the placement of stents in damaged arteries after angioplasty.
Although the potential benefit from using such bioactive agent-releasing medical devices is great, development of such medical devices has been slow.
Progress has been hampered by many challenges, including: 1) the requirement, in some instances, for long term (i.e., at least several weeks) release of bioactive agents; 2) the need for a biocompatible, non-inflammatory device surface; 3) the demand for significant durability (and particularly, resistance to delamination and cracking), particularly with devices that undergo flexion and / or expansion when being implanted or used in the body; 4) concerns regarding the ability of the device to be manufactured in an economically viable and reproducible manner; and 5) the requirement that the finished device can be sterilized using conventional methods.

Method used

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  • Coating compositions for bioactive agents
  • Coating compositions for bioactive agents
  • Coating compositions for bioactive agents

Examples

Experimental program
Comparison scheme
Effect test

example 1

Release of Rapamycin from Poly(ethylene-co-methyl acrylate) and Poly(butyl methacrylate)

[0124] Three solutions were prepared for coating the stents. All three solutions included mixtures of poly(ethylene-co-methyl acrylate) (“PEMA”, available from Focus Chemical Corp. Portsmouth, N.H., containing 28% (wt) methyl acrylate), poly(butyl methacrylate) (“PBMA”, available from Sigma-Aldrich Fine Chemicals as Product No. 18,152-8, having a weight average molecular weight (Mw) of about 337 kilodaltons), and rapamycin (“RAPA”, available from LC Laboratories, Woburn, Mass.) dissolved in tetrahydrofuran (THF) to form a homogeneous solution. The stents were not given a primer pre-treatment.

[0125] The solutions were prepared to include the following ingredients at the stated weights per milliliter of THF: [0126] 1) 16 mg / ml PEMA / 4 mg / ml PBMA / 10 mg / ml RAPA [0127] 2) 10 mg / ml PEMA / 10 mg / ml PBMA / 10 mg / ml RAPA [0128] 3) 4 mg / ml PEMA / 16 mg / ml PBMA / 10 mg / ml RAPA

[0129] Using the Sample Preparation P...

example 2

Release of Dexamethasone from Poly(ethylene-co-methyl acrylate) and Poly(butyl methacrylate)

[0131] Three solutions were prepared for coating the stents. All three solutions included mixtures of poly(ethylene-co-methyl acrylate) (“PEMA”), poly(butyl methacrylate) “PBMA”, and dexamethasone (“DEXA”, available as Product No. 86,187-1 from Sigma Aldrich Fine Chemicals) dissolved in THF to form a homogeneous solution. The stents were not given a primer pre-treatment. The solutions were prepared to include the following ingredients at the stated weights per milliliter of THF: [0132] 1) 20 mg / ml PEMA / 0 mg / ml PBMA / 10 mg / ml DEXA [0133] 2) 10 mg / ml PEMA / 10 mg / ml PBMA / 10 mg / ml DEXA [0134] 3) 0 mg / ml PEMA / 20 mg / ml PBMA / 10 mg / ml DEXA

[0135] Using the Sample Preparation Procedure, two stents were spray coated using each solution. After solvent removal via ambient evaporation, the drug elution for each coated stent was monitored using the Dexamethasone Release Assay Procedure.

[0136] Results, prov...

example 3

Surface Characterization of Coated Stents after Crimping and Expansion

[0137] Using the Sample Preparation Procedure, stents were sprayed with a coating of second polymer / poly(butyl methacrylate)(“PBMA”) / rapamycin(“RAPA”), mixed at a weight ratio of 33 / 33 / 33 at 10 mg / ml each of THF. The first polymer was poly(ethylene-co-methyl acrylate) (“PEMA”, available from Focus Chemical Corp. Portsmouth, N.H., containing 28% (wt) methyl acrylate). The second polymer used was PBMA from Sigma-Aldrich Fine Chemicals as Product No. 18,152-8, having a weight average molecular weight (Mw) of about 337 kilodaltons. Stents were either used as received (i.e., uncoated metal), were pre-treated with a silane / Parylene™ primer using the primer procedure described in the Sample Preparation Procedure, were not pre-treated with primer but were given a subsequent PBMA topcoat using the spraying process described in the Sample Preparation Procedure, or were given both a silane / Parylene™ pre-treatment primer and...

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Abstract

A coating composition and related method for use in applying a bioactive agent to a surface in a manner that will permit the bioactive agent to be released from the coating in vivo. The composition is particularly well suited for coating the surface of implantable medical device, such as a stent or catheter, in order to permit the device to release bioactive agent to the surrounding tissue over time. The composition includes a plurality of compatible polymers having different properties that can permit them to be combined together to provide an optimal combination of such properties as durability, biocompatibility, and release kinetics.

Description

RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application Ser. No. 60 / 559,821, titled Coating Compositions for Bioactive Agents, filed Apr. 6, 2004, the contents of which are hereby incorporated by reference.TECHNICAL FIELD [0002] In one aspect, the present invention relates to a method of treating implantable medical devices with coating compositions to provide for the controlled release of bioactive (e.g., pharmaceutical) agents from the surface of the devices under physiological conditions. In another aspect, the invention relates to the coating compositions, per se. In yet another aspect, the invention relates to devices or surfaces coated with such compositions. In yet another aspect, the present invention relates to the local administration of bioactive agents for the prevention and treatment of diseases, such as vascular and ocular diseases. BACKGROUND OF THE INVENTION [0003] Many surgical interventions require the placement of a medical ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61F2/00A61F2/86A61K9/14A61L29/08A61L29/16A61L31/10A61L31/16
CPCA61F2/86A61F2250/0067A61L2300/606A61L2300/602A61L2300/43A61L2300/42A61L2300/416A61L2300/41A61L2300/404A61L29/085A61L29/16A61L31/10A61L31/16A61L2300/222C08L33/06C08L33/10C08L71/02
Inventor DEWITT, DAVID M.FINLEY, MICHAEL J.LAWIN, LAURIE R.
Owner SURMODICS INC
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