Drug releasing coating for medical device

A technology of medical equipment and coating, applied in the field of drug release coating for medical equipment, which can solve problems such as easy hydrolysis or oxidation, sensitivity to moisture, and complexity

Inactive Publication Date: 2015-08-26
路通医疗股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is further complicated by the large surface area of ​​drug-coated medical devices and exposure to heat, humidity and oxidative states during sterilization
These are especially problematic if the therapeutic drug is moisture sensitive or prone to hydrolysis or oxidation

Method used

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  • Drug releasing coating for medical device
  • Drug releasing coating for medical device
  • Drug releasing coating for medical device

Examples

Experimental program
Comparison scheme
Effect test

Embodiment A

[0285] Preparation of coating solution (if necessary, add not more than 10% by volume of a small amount of water sufficient to dissolve all solutes):

[0286] Formulation 1.1 - 30-90mg rapamycin, 1-2% (based on the weight of rapamycin) butylated hydroxytoluene (BHT), 15-90mg Tween 80, 30-90mg docusate sodium (sulfonate Sodium diethylhexyl succinate) and 1-3ml ethanol were mixed.

[0287] Formulation 1.2 - Mix 30-90mg rapamycin, 1-2% (based on weight of rapamycin) butylated hydroxyanisole (BHA), 15-90mg Tween 80, 30-90mg docusate sodium (Sodium diethylhexyl sulfosuccinate) and 1-3ml ethanol were mixed.

[0288] Formulation 1.3 - Mix 30-90 mg rapamycin without added BHT or BHA, 15-90 mg Tween 80, 30-90 mg docusate sodium (diethylhexyl sodium sulfosuccinate) and 1-3 ml ethanol .

[0289] Formulation 1.4 - Mix 30-90mg rapamycin, 1-2% (based on the weight of rapamycin) BHA or BHT, 15-90mg Solutol HS 15, 5-30mg sodium lauryl sulfate and 1-3ml ethanol mix.

[0290] Formulation 1...

Embodiment B

[0312] Five PTCA balloon catheters (3 mm in diameter and 20 mm in length) were coated using the method described in US Patent Application Publication No. 2010-0055294-A1 , which is hereby incorporated by reference in its entirety. Inflate the PTCA balloon catheter at 1-3 atmospheres. The inflated balloons were loaded, sprayed or dipped into the formulations of Example A (1.1-1.3). Then, the balloons were dried, drug loaded, sprayed or dipped again until balloons with sufficient amount of drug (3 μg / mm) were obtained. The coated balloons are folded, then repackaged and sterilized for analytical testing. The recovered rapamycin content was 79% for Formulation 1.1 with BHT; 100% for Formulation 1.2 with BHA; and 14%-50% for Formulation 1.3 without BHT or BHA. Antioxidants (BHT or BHA) prevent rapamycin from being oxidized or degraded.

Embodiment C

[0314] Six PTCA balloon catheters (3.5 and 3.0 mm in diameter and 20 mm in length) were inflated at 1-3 atmospheres. The inflated balloons were loaded with formulations 1.1-1.25 in Example A. A sufficient amount of drug (3-4 μg / mm2) was obtained on the balloon. The inflated balloon is folded and allowed to dry. The coated folded balloon is then repackaged, sterilized, and optionally vacuum dried for animal testing.

[0315] step : Insertion of coated PTCA balloon catheters into target sites (LAD, LCX and RCA) in the coronary vessels of 25-45 lb pigs. The balloon is inflated to about 12 atmospheres of pressure. The overdraw ratio (the ratio of balloon diameter to tube diameter) is about 1.15-1.40. During 30-60 seconds of inflation, the drug is delivered to the target tissue. Then, the balloon catheter is deflated and recovered from the animal. Target vessels were harvested 0.25-24 hours after the procedure. The drug content in the target tissue and the residual drug re...

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Abstract

The invention relates to a medical device for delivering a therapeutic agent to tissue. The medical device is provided with a coating that covers outer surface of the medical device. The coating contains the therapeutic agent, an antioxygen agent and an additive. In certain specific embodiments, the additive has a hydrophilic portion and a drug affinity portion, and at least one portion among a hydrophobic portion, a portion with the affinity to the therapeutic agent through a hydrogen bond and a portion with the affinity to the therapeutic agent through a van der waals interaction can serve as the drug affinity portion. In certain specific embodiments, the additive is a liquid. In other specific embodiments, at least one substance among surface active agents and compounds can serve as the additive, and the compounds have one or more hydroxyls, amino groups, carbonyls, carboxyls, acids, amides or ester groups.

Description

[0001] This divisional application is based on the divisional application of the original Chinese patent application with the application number 201080066594.6, the filing date is March 25, 2010, and the invention title is "Drug Release Coating for Medical Devices". [0002] Cross References to Related Applications [0003] This application is a continuation-in-part of Application No. 12 / 121,986, filed May 16, 2008, which is a continuation-in-part of Application No. 11 / 942,452, filed November 19, 2007, claimed on November 20, 2006 U.S. Provisional Application No. 60 / 860,084 filed on January 17, 2007, U.S. Provisional Application No. 60 / 880,742 filed on January 17, 2007, U.S. Provisional Application No. 60 / 897,427 filed on January 25, 2007, February 2007 U.S. Provisional Application No. 60 / 903,529 filed on 26th, U.S. Provisional Application No. 60 / 904,473 filed on March 2, 2007, U.S. Provisional Application No. 60 / 926,850 filed on April 30, 2007, US Provisional Application No. 6...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L29/08A61L29/10A61L29/16A61L27/30A61L27/34A61L27/54A61L31/08A61L31/10A61L31/16
Inventor L·王
Owner 路通医疗股份有限公司
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