Coating composition and medical device

Patent metadata

Field	Value
Publication number	US-2016015864-A1
Application number	US-201514859913-A
Country	US
Kind code	A1
Filing date	Sep 21, 2015
Priority date	Apr 1, 2013
Publication date	Jan 21, 2016
Grant date	—

Abstract

A coating composition capable of forming a drug coating layer unsusceptible to peeling in the process of delivery of a water-insoluble drug to a target tissue is provided. The coating composition contains the water-insoluble drug and a basic compound which is positively charged at physiological pH. A medical device coated with the coating composition is further provided.

First claim

What is claimed is:

1 . A coating composition to be used for a drug-eluting medical device, the coating composition containing a water-insoluble drug and a basic compound which is positively charged at physiological pH.

2 . The coating composition according to claim 1 , wherein the basic compound is at least one selected from the group consisting of a basic compound having an amidino group, a basic compound having a piperidine ring, a basic compound having two or more amino groups in one molecule thereof, a quaternary ammonium cation, and salts thereof.

3 . The coating composition according to claim 1 , wherein the basic compound is at least one selected from the group consisting of compounds represented by the following general formula (I) and salts thereof:

where A is an aromatic ring, R 1 and R 2 are each independently an alkyl or alkenyl group of 10 to 25 carbon atoms, X 1 and X 2 are each independently O, S, COO, OCO, CONH or NHCO, m is 0 or 1, and n is 0 or an integer of 1 to 6.

4 . The coating composition according to claim 1 , wherein the basic compound is at least one selected from the group consisting of compounds represented by the following general formula (II) and salts thereof:

where R 3 and R 4 are each independently an alkyl group of 10 to 18 carbon atoms.

5 . The coating composition according to claim 1 , wherein the basic compound is at least one selected from the group consisting of compounds represented by the following general formula (III) and salts thereof:

where R 5 are each independently an alkyl group of 10 to 18 carbon atoms.

6 . The coating composition according to claim 1 , wherein the basic compound is at least one selected from the group consisting of compounds represented by the following general formula (IV) and salts thereof:

where R 6 are each independently an alkyl group of 10 to 18 carbon atoms.

7 . The coating composition according to claim 1 , wherein the basic compound is 3,5-dipentadecyloxybenzamidine and/or a salt thereof.

8 . The coating composition according to claim 1 , further containing a lower alcohol.

9 . The coating composition according to claim 8 , wherein the lower alcohol is glycerin.

10 . The coating composition according to claim 1 , wherein the water-insoluble drug is at least one selected from the group consisting of rapamycin, paclitaxel, docetaxel, and everolimus.

11 . The coating composition according to claim 1 , wherein the medical device is a medical device which can be expanded in a radial direction within a lumen.

12 . The coating composition according to claim 11 , wherein the medical device is a balloon or a catheter.

13 . A drug coating layer formed, by use of the coating composition according to claim 1 , on at least part of a surface of the medical device.

14 . A medical device provided with the drug coating layer according to claim 13 .

15 . A treating method comprising:
delivering the medical device according to claim 14 into a lumen; radially expanding the medical device within the lumen; and eluting a drug from the drug coating layer formed on at least part of the surface of the medical device and permitting the drug to act on the lumen.

Assignees

• Terumo Corp

Inventors

• Yamashita Keiko
• Nozawa Shigenori

Classifications

• A61L31/08

  Materials for coatings · CPC title

• A61K31/436

  the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin · CPC title

• A61L31/16

  Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} · CPC title

• A61L2420/06

  Coatings containing a mixture of two or more compounds · CPC title

• A61M2025/105

  having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes · CPC title