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Coatings with crystallized active agent(s) and methods

a technology of active agents and crystallized active agents, applied in the field of coating compositions, can solve the problems of maintaining an inventory and the cost of maintaining an inventory, and achieve the effects of enhancing the formation of active agent crystals, increasing the rate of active agent nucleation, and enhancing the crystallization of active agents

Inactive Publication Date: 2006-06-22
SURMODICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0006] The present invention relates to coatings with crystallized active agent(s) and related methods. In an embodiment, the invention includes a method for coating a medical device including selecting a solvent and a polymer, selecting a concentration of an active agent of at least a certain amount of saturation, forming a coating composition having the selected concentration of the active agent, and applying the coating composition to the medical device. In an embodiment, the invention includes an elution control coating disposed on a medical device, the elution control coating including a polymer, and an active agent, wherein the active agent is at least about 80% crystallized within one week of being disposed on the medical device. In an embodiment, the invention includes a method for enhancing the formation of active agent crystals within a coating layer including forming a coating solution and adjusting the concentration of the active agent in the coating solution to reach some percentage of the active agent saturation point. In an embodiment, the invention includes a method of enhancing crystallization of an active agent, the method including forming a coating solution comprising a polymer, an active agent, and a solvent; applying the coating solution to a substrate; and increasing the rate of active agent nucleation within the coating.

Problems solved by technology

Specifically, in some applications it can be problematic if two devices manufactured in the same batch have significantly different elution rates, or if the elution rates vary significantly between separate batches.
Finally, shelf stability of coated devices is of significance as an excessively short shelf-life may raise costs associated with maintaining an inventory sufficient to meet demand.

Method used

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  • Coatings with crystallized active agent(s) and methods
  • Coatings with crystallized active agent(s) and methods
  • Coatings with crystallized active agent(s) and methods

Examples

Experimental program
Comparison scheme
Effect test

example 1

Preparation of Coating Solutions Saturated / Unsaturated

[0103] Coating solutions were prepared with various concentrations of drug, polymers, and solvents. Specifically, five different coating solutions were prepared as follows (the coating solutions are summarized in Table 1 below):

[0104] Solution 1: Estradiol was combined with THF (tetrahydrofuran) to form an active agent solution. PEVA (polyethylene-co-vinyl acetate, 33% vinyl acetate) and PBMA (poly-n-butyl methacrylate) were combined with toluene to form a polymer solution. The active agent solution and the toluene solution were combined to form a coating solution having 40 mg / ml total solids including 30 wt. % estradiol, 20 wt. % PEVA, and 50 wt. % PBMA in a solvent of 80% toluene and 20% THF (four parts toluene to one part THF). The coating solution was allowed to stand for a period of minutes at ambient temperature and was observed to be clear, indicating that the estradiol was at a soluble concentration for this solvent com...

example 2

Non-Saturated Coating Composition with THF / IPA Solvent

[0110] Estradiol, polyethylene-co-vinyl acetate (PEVA) (33% vinyl acetate), and poly-n-butyl methacrylate (PBMA) were combined in equal weight proportions in a solution that was 90% tetrahydrofuran (THF) and 10% isopropyl alcohol (IPA). The resulting solution had a total solids concentration of 40 mg / ml (33% PEVA / 33% PBMA / 33% estradiol). The resulting solution was below the saturation point for estradiol in a solvent of 90% THF / 10% IPA at ambient temperature (approximately 21-22° C.).

[0111] A stainless steel stent 18 mm in length was obtained and prepared by first applying a layer of parylene C using a vapor-deposition technique. After the parylene was disposed onto the stent, the coating solution was applied to the stent using an ultrasonic spray technique at a relative humidity of 10%. Ultrasonic spray techniques are disclosed in U.S. Published Application 2004 / 0062875 (Chappa et al.) the contents of which are herein incorpor...

example 3

Non-Saturated Coating Composition with Chloroform / Methanol Solvent

[0115] Estradiol, polyethylene-co-vinyl acetate (PEVA) (33% vinyl acetate), and poly-n-butyl methacrylate (PBMA) were combined in equal weight proportions in a solution that was 80% chloroform and 20% methanol. The resulting solution had a total solids concentration of 40 mg / ml (33% PEVA / 33% PBMA / 33% estradiol). The resulting solution was below the saturation point for estradiol in a solvent of 80% chloroform / 20% methanol at ambient temperature (approximately 21-22° C.).

[0116] A stainless steel stent 18 mm in length was obtained and prepared by first applying a layer of parylene C using a vapor-deposition technique. After the parylene was disposed onto the stent, the coating solution was applied to the stent using an ultrasonic spray technique. A total coating weight of 683 μg was applied to the stent (measured after the solvent had substantially evaporated off) resulting in a drug loading of approximately 225 μg of...

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Abstract

The present invention relates to coatings with crystallized active agent(s) and related methods. In an embodiment, the invention includes a method for coating a medical device including selecting a solvent and a polymer, selecting a concentration of an active agent of at least a certain amount of saturation, forming a coating composition having the selected concentration of the active agent, and applying the coating composition to the medical device. In an embodiment, the invention includes an elution control coating disposed on a medical device, the elution control coating including a polymer, and an active agent, wherein the active agent is at least about 80% crystallized within one week of being disposed on the medical device. In an embodiment, the invention includes a method for enhancing the formation of active agent crystals within a coating layer including forming a coating solution and adjusting the concentration of the active agent in the coating solution to reach some percentage of the active agent saturation point. In an embodiment, the invention includes a method of enhancing crystallization of an active agent, the method including forming a coating solution comprising a polymer, an active agent, and a solvent; applying the coating solution to a substrate; and increasing the rate of active agent nucleation within the coating.

Description

[0001] This application claims the benefit of U.S. Provisional Application No. 60 / 634,070, filed Dec. 7, 2004, the contents of which are herein incorporated by reference.FIELD OF THE INVENTION [0002] The present invention relates to coating compositions and related methods. More specifically, the present invention relates to coatings with crystallized active agent(s) and related methods. BACKGROUND OF THE INVENTION [0003] Therapeutic benefits can be achieved in some instances by providing an active agent to a specific target tissue, instead of systemically. This is because the effect of the agent on the target tissue can be maximized while limiting side effects on other tissues. Therapeutic benefits can also be achieved by providing an active agent to a subject in a manner that extends the time over which the active agent is released. One approach to providing these benefits is to use a coating system containing an active agent on a medical device. [0004] Predictability and consiste...

Claims

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Application Information

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IPC IPC(8): A61K6/083A61K31/56B05D3/02
CPCA61K6/0017A61K31/56A61L27/34A61L27/50A61L27/54A61L31/10A61L31/14A61L31/16A61L2300/222A61L2300/43A61L2300/606A61L2300/63A61L2420/02A61K6/20A61L2300/216A61L2300/602A61L2420/06
Inventor CHAPPA, RALPH A.LINDSOE, KIMBERLY K.M.
Owner SURMODICS INC
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