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Controlled drug release composition and drug releasing medical device

A release-controlled, medical device technology

Inactive Publication Date: 2008-11-19
TOKAI UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current situation is that, until now, there have been no cases where antithrombin drugs such as argatroban or sargrelate hydrochloride were used in stents and their effects were specifically verified, and the release of the drugs necessary for the stent to exhibit anticoagulant properties has not been confirmed. speed is completely unknown

Method used

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  • Controlled drug release composition and drug releasing medical device
  • Controlled drug release composition and drug releasing medical device
  • Controlled drug release composition and drug releasing medical device

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～3、 comparative example 1～3

[0138] As shown in Table 1, dissolve 90 mg of polylactic acid and lactic acid / glycolic acid copolymer, 10 mg of triethyl citrate as a release aid, and 10 mg of sarcogrelate hydrochloride as an antiplatelet drug in 1 mL of hexafluoroisopropanol , cast on a glass dish with a diameter of 41 mm, and air-dry to obtain a drug carrier. Soak it in 100 mL of pH 7.4 phosphate buffer, sample the buffer regularly, and measure the absorbance (Abs) at 270 nm as the characteristic absorption band of sarcogrelate hydrochloride, thereby tracking the amount of dissolution of the drug. Table 1 shows the absorbance values ​​from the start of dissolution to 3 weeks after.

[0139] As Comparative Examples 1 to 3, the same dissolution test was performed under the same conditions as in the Examples except that no release aid was added.

[0140] [Table 1]

[0141] polymer

Embodiment 4～6、 comparative example 4

[0143] Dissolve 90 mg of lactic acid / glycolic acid (50 / 50) copolymer, 10 mg of alkyl tartrate diester as a release aid, and 10 mg of sarcogrelate hydrochloride as an antiplatelet drug in 1 mL of hexafluoroisopropanol. Cast on a glass dish with a diameter of 41mm, and air-dry to obtain the drug carrier. Soak it in 100 mL of pH 7.4 phosphate buffer, sample the buffer regularly, and measure the absorbance at 270 nm, which is the characteristic absorption band of sarcogrelate hydrochloride, so as to track the amount of dissolution of the drug. Table 2 shows the absorbance values ​​from the start of the dissolution to 3 weeks later.

[0144] [Table 2]

[0145] release aid

Embodiment 7～10、 comparative example 5、6

[0147] As shown in Table 3, 90 mg of polylactic acid and lactic acid / glycolic acid copolymer, 10 mg of diethyl tartrate or triethyl citrate as a release aid, and 10 mg of argatroban as an antithrombin drug were dissolved in Cast in 1 mL of hexafluoroisopropanol on a glass dish with a diameter of 41 mm, and air-dry to obtain the drug carrier. It was soaked in 100 mL of pH 7.4 phosphate buffer solution, the buffer solution was regularly sampled, and the absorbance value at 330 nm, which is the characteristic absorption band of argatroban, was measured to track the dissolution amount of the drug. Table 3 shows the absorbance values ​​from the start of the dissolution to 3 weeks afterward.

[0148] As Comparative Examples 5 and 6, the same dissolution test was performed under the same conditions as in the Examples except that no release aid was added.

[0149] [table 3]

[0150] Polymer (90mg)

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Abstract

A drug releasing medical device of the invention is provided with a controlled drug release composition containing 100 parts by weight of an organic polymeric material which is soluble in an organic solvent and insoluble in water, 5 to 60 parts by weight of a release auxiliary agent which is lipid-soluble and low in molecular weight and a 1 to 70 parts by weight of a drug. When the composition is applied to a stent, a catheter, an organ replacement medical device, an artificial organ or the like in the form of coating or the like, a drug releasing function is given to the medical device. From a surface of a stent for treating coronary stenosis, which is a preferred embodiment, argatroban, sarpogrelate hydrochloride or both of them are released gradually. In order to express a controlled release property in a desired period of time, the drug to be released gradually is carried in a polymeric material coated on a metal surface constituting the stent or in a porous stent substrate. It is preferred that the polymeric material is noncrystalline and further biodegradable and contains a tartaric acid ester, a malic acid ester or a monoester or diester of glycerine as the release auxiliary agent.

Description

technical field [0001] The present invention relates to a controlled drug release composition and the like, and more particularly to a controlled drug release composition imparting a drug release function to a medical device and the like, and a drug releasing medical device holding it, particularly a stent. Background technique [0002] In recent years, in order to effectively exert the drug effect, not only new drugs but also known drugs have been vigorously developed for their formulations and drug delivery techniques. For example, there is a preparation technology in which a special film is used to coat the medicament so that the effective components are released after a certain period of time. In addition, based on the concept of drug delivery system (DDS), formulation technology utilizing liposomes, nanospheres, and microcapsules has been extensively studied. In addition, the functions pursued by these DDS include release controllability, target orientation, ease of in...

Claims

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Application Information

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IPC IPC(8): A61K47/14A61L31/00A61K47/34A61P35/00A61K9/70A61P37/06A61L27/00A61P7/02A61L29/00
Inventor 望月明山下修藏
Owner TOKAI UNIV
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