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Medical product with active ingredient coating and method for producing the same

A technology of active material coating and active material, which is applied in the field of medical products for the treatment of vascular diseases, and can solve the problems of low adhesion on the surface of stents or balloons

Inactive Publication Date: 2016-08-10
NEW YORK CITY DEPARTMENT OF TRANSPORTATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The known methods of preparing coated stents or balloon catheters by spraying and dipping from volatile organic solvents generally result in coatings of readily soluble active substances with a smooth amorphous structure, which are compatible with stents or balloons Capsule surface has low adhesion and releases easily to the vessel wall

Method used

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  • Medical product with active ingredient coating and method for producing the same
  • Medical product with active ingredient coating and method for producing the same
  • Medical product with active ingredient coating and method for producing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] 10 mg of paclitaxel in solid form was provided by drying a stock solution of paclitaxel in ethyl acetate having defined concentrations. Paclitaxel was absorbed into a mixture of ethyl acetate and different contents of dimethylsulfoxide (DMSO) and it was checked whether a clear solution formed after 72 hours at room temperature.

[0067] In another group (Ansatz) the maximum solubility of paclitaxel in DMSO was determined to be 400 mg / ml.

[0068] Solution experiments showed that the composition of the coating solution consisting of 10 mg paclitaxel in 200 μl ethyl acetate and 12 μl DMSO already gave the desired transparent solution. The active substance content in this solution is about 833 mg / ml DMSO, thus approximately 2.1 times the maximum solubility of paclitaxel in DMSO.

Embodiment 2

[0070] A coating solution of 10 mg paclitaxel in 200 μl ethyl acetate and 22 μl DMSO was prepared. In this coating solution, the active substance content was 454 mg paclitaxel / ml DMSO, which is about 13.5% higher than the maximum solubility of paclitaxel in DMSO. Therefore, the solution contained an insufficient amount of DMSO to completely dissolve paclitaxel (10 mg) contained in a solvent mixture of 200 μl ethyl acetate and 22 μl DMSO.

[0071] The coating solution was applied to a stainless steel panel and left at room temperature under normal pressure until the solvent evaporated completely. A paclitaxel coating with a crystal structure was obtained.

[0072] The coating experiment was repeated using the solution from example 1 (10 mg of active substance in 200 μl of ethyl acetate and 12 μl of DMSO), again obtaining a crystalline coating of paclitaxel.

[0073] exist figure 1 In , an electron micrograph of the coating obtained from the coating solution of Example 2 at m...

Embodiment 3

[0076] 10 mg paclitaxel was dissolved in 2000 μl ethyl acetate and 22 μl DMSO. Unlike Example 2, the amount of the volatile first solvent was increased tenfold.

[0077] The coating solution thus obtained was applied to a stainless steel plate and left at room temperature under normal pressure until the solvent evaporated completely. A paclitaxel coating with a crystalline structure was also obtained. It can thus be shown that the second solvent remains in the coating even in the case of intensive dilution with the volatile first solvent and that the active substance recrystallizes into crystalline form after removal of the first solvent.

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Abstract

A medical device with an active ingredient coating comprises a substrate with a surface and a coating applied to the surface which contains the active ingredient. The method of manufacturing the medical device comprises the steps of: providing the substrate with the surface; providing a solution of the active agent in a mixture of at least a first and a second solvent, the active agent being soluble in both the first and second solvents; applying the solution to at least a portion of the surface of the substrate; and removing the solvents to form a coating containing the active agent on the surface; wherein the first solvent has a boiling point below 100 DEG C and the second solvent has a boiling point above 130 DEG C and the solution contains the active ingredient and the second solvent in a proportion such that the proportion of the active ingredient is above the solubility limit of the active ingredient in the active substance by weight of the second solvent and wherein the removal of the solvents is controlled in such a way that, after removal of the solvents, the coating which contains the active substance in crystalline form is obtained.

Description

technical field [0001] The invention relates to a medical product coated with an active substance, in particular for the treatment of vascular diseases, and to a method for its preparation. Background technique [0002] Diseased narrowed blood vessels (stenosis) can be treated by implanting a vessel support such as a stent and / or dilating the vessel wall with a balloon catheter. A balloon applied to the vascular catheter is introduced through an artery, for example a leg artery, and advanced under radiographic imaging to the narrowed vessel. There the balloon slowly opens under pressure. As a result, the stenosis is dilated and the blood flow is undisturbed. A stent may also be implanted to prevent restenosis. Drug-coated stents may be used depending on the location of the stenosis, vessel size, and pre-existing disease. [0003] Some patients narrow again (restenosis) months after the narrowing has dilated. Restenosis may be caused by hyperplasia, especially of smooth ...

Claims

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Application Information

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IPC IPC(8): A61L29/16A61L31/16A61L29/08A61L31/10
CPCA61L29/085A61L29/16A61L31/10A61L31/16A61L2300/416A61L2300/606A61L2300/63C08L93/02C08L29/04A61L2420/02
Inventor 汉斯-乔治·诺伊曼米沙·布尔梅斯特
Owner NEW YORK CITY DEPARTMENT OF TRANSPORTATION
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