drug coating

A drug coating and drug technology, applied in coatings, drug combinations, medical science, etc., can solve the problems of high stenosis inhibition rate, low toxicity, and unproven stenosis inhibition effect, and achieve high inhibition effect and low toxicity Effect

Active Publication Date: 2017-07-21
TERUMO KK
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In Patent Documents 1 to 3, there is no mention of toxicity at all, and the crystal form classification of drugs for obtaining the performance of high stenosis inhibitory effect and low toxicity has not yet been found.
[0008] In summary, the drug-eluting balloon with a coating layer in the prior art cannot be said to be sufficiently effective in treating intravascular stenosis with less toxicity and a high stenosis inhibition rate, and it is expected that the toxicity will be higher. Medical device with low and high stenosis suppression effect

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0093] (1) Preparation of coating solution 1

[0094] Measure L-serine ethyl ester hydrochloride (CAS No. 26348-61-8) (56 mg) and paclitaxel (CAS No. 33069-62-4) (134.4 mg). Absolute ethanol (1.2 mL), tetrahydrofuran (1.6 mL), and RO (Reverse Osmosis, reverse osmosis membrane) treated water (hereinafter referred to as RO water) (0.4 mL) were added to the above components and dissolved to prepare coating solution 1 .

[0095] (2) Drug application to the balloon

[0096] A balloon catheter (manufactured by Terumo Co., Ltd., the material of the balloon (expansion portion) is nylon elastomer) with a diameter of 3.0×length 20 mm (expansion portion) was prepared. The amount of paclitaxel in coating solution 1 is about 3 μg / mm 2 coated on the inflated balloon in such a way that the solvent in the coating solution evaporates slowly. Specifically, the drug is discharged from the opening of the front end of the dispensing tube while the side surface of the front end of the dispensin...

Embodiment 2

[0099] (1) Preparation of coating solution 2

[0100] Measure L-serine ethyl ester hydrochloride (70mg) and paclitaxel (180mg). Anhydrous ethanol (1.5 mL), acetone (2.0 mL), tetrahydrofuran (0.5 mL), and RO water (1 mL) were added and dissolved to the above-mentioned components, respectively, to prepare a coating solution 2 .

[0101] (2) Drug application to the balloon

[0102] A balloon catheter (manufactured by Terumo Co., Ltd., the material of the balloon (expansion portion) is nylon elastomer) with a diameter of 3.0×length 20 mm (expansion portion) was prepared. The amount of paclitaxel in coating solution 2 is about 3 μg / mm 2 coated on the inflated balloon in such a way that the solvent in the coating solution evaporates slowly. Specifically, coating was performed in the same manner as described in Example 1 except that the drug was discharged at 0.088 μL / sec.

[0103] Thereafter, the coated balloon is dried to prepare a drug-eluting balloon.

Embodiment 3

[0105] (1) Preparation of coating solution 3

[0106] Measure L-serine ethyl ester hydrochloride (70mg) and paclitaxel (168mg). Anhydrous ethanol (1.5 mL), tetrahydrofuran (1.5 mL), and RO water (1 mL) were added and dissolved to the above-mentioned components, respectively, to prepare a coating solution 3 .

[0107] (2) Drug application to the balloon

[0108] A balloon catheter (manufactured by Terumo Co., Ltd., the material of the balloon (expansion portion) is nylon elastomer) with a diameter of 3.0×length 20 mm (expansion portion) was prepared. The amount of paclitaxel in coating solution 3 is about 3 μg / mm 2 coated on the inflated balloon in such a way that the solvent in the coating solution evaporates slowly. Specifically, coating was carried out in the same manner as described in Example 1 except that the drug was discharged at 0.101 μL / sec.

[0109] Thereafter, the coated balloon is dried to prepare a drug-eluting balloon.

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Abstract

The object of the present invention is to provide a drug coating with low toxicity and a high stenosis inhibition rate when the drug is applied to the medical device and delivered to the body, and a medical device using the drug coating. It is a morphologically typed drug coating that has a plurality of strips of crystals containing water-insoluble drugs on the surface of the substrate. The plurality of strips are each independent and have a long axis, and the long axis of the strip is It is substantially linear, and forms an angle within a predetermined range with respect to a substrate plane where the long axis of the elongated body intersects.

Description

technical field [0001] The present invention relates to a drug coating of a water-insoluble drug, and relates to a drug coating exhibiting a specific morphological form of the water-insoluble drug. Background technique [0002] In recent years, the development of a drug-eluting balloon (Drug Eluting Balloon; DEB) in which a drug is applied to a balloon catheter has been actively carried out, and it has been reported that it is effective in the treatment and prevention of restenosis. The balloon is coated with a coating containing drugs and additives, and when the blood vessel is dilated, the balloon is pressed against the wall of the blood vessel so that the drug can be delivered to the target tissue. [0003] In recent years, it has been gradually found that the morphological form of the drug coated on the surface of the balloon has an impact on the release and tissue transfer of the drug from the surface of the balloon in the lesion. Quality (amorphous) control is importa...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L31/08A61L31/16A61M25/10
CPCA61L29/08A61L29/16A61L31/08A61L31/16A61M25/10A61L2300/416A61L2300/63A61M2025/105A61M25/104A61P35/00A61P37/06A61L31/00A61K9/0004
Inventor 山下惠子后藤博野泽滋典森本克己粕川博明
Owner TERUMO KK
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