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Loading and release of water-insoluble drugs

a technology of water-soluble drugs and loading and release, which is applied in the direction of prosthesis, catheters, blood vessels, etc., can solve the problems of systemic administration not being desirable, and having a limitation of being applicable to drug agents

Inactive Publication Date: 2008-01-24
BOSTON SCI SCIMED INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0006] A further objective of the present invention is to provide a method and apparatus to facilitate gradual, localized release of drug agents at predetermined locations within the human body.
[0011] In a most preferred embodiment, the stent is a patterned stent for the localized delivery of paclitaxel to tissue at a desired location along body lumen walls. The stent is at least partially coated with a polymer / paclitaxel matrix that provides sustained release of paclitaxel at the desired site within the lumen wall.

Problems solved by technology

In such a case, systemic administration may not be desirable because, for example, the drug agents may have unwanted effects on parts of the body which are not to be treated, or because treatment of the diseased part of the body requires a high concentration of drug agent that may not be achievable by systemic administration.
This method of localized drug delivery using hydrogel polymer impregnation. has a limitation of being applicable to drug agents which are dissolved in water at concentrations sufficient for therapeutic gel loading levels.

Method used

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  • Loading and release of water-insoluble drugs
  • Loading and release of water-insoluble drugs
  • Loading and release of water-insoluble drugs

Examples

Experimental program
Comparison scheme
Effect test

example 1

Release Kinetics of Paclitaxel from Polyacrylic Acid-Based Coating

[0058] A 2 mg / ml solution of paclitaxel is prepared in chloroform. The solution is gently agitated until the paclitaxel is completely dissolved. The solution is applied via pipet to a balloon catheter having a polyacrylic acid-based coating and inflated to 2 atm. A total of 100 μl of solution, and hence 200 μg of paclitaxel, is applied to the catheter. The balloon catheter is then dried in air for 30 minutes and in a vacuum oven for 48 hours at 50° C. to evaporate the chloroform. The catheter is then immersed in a solution of 1% dimethyl sulfoxide (DMSO) and phosphate buffered saline(PBS) having a pH of 7.4 for in-vitro drug release. The cumulative amount of paclitaxel released from the catheter coating yields the data shown in FIGS. 3a and 3b.

example 2

Release Kinetics of Dexamethasone from Polyacrylic Acid-Based Coating

[0059] Solutions containing 1.5 mg / ml and 200 μg / ml of dexamethasone in chloroform, are prepared by gently agitating until the dexamethasone is completely dissolved. The solutions are separately applied via dripping to separate balloon catheters having polyacrylic acid-based coatings and inflated to 2 atm. A total of 100 μl of each solution is applied to each respective catheter, corresponding to dexamethasone loadings of 1.5 mg and 200 μg, respectively. These results can be contrasted with the inability to apply substantial amounts of dexamethasone to polyacrylic acid-based coatings using aqueous solutions, in which case only about 1 μg of dexamethasone can be loaded into such coatings. The balloon catheters are then dried in a vacuum oven for 2 hours at 50° C. to evaporate the chloroform solvent. The catheters are thereafter immersed in PBS (pH=7.4) to track the release of dexamethasone over time. The cumulative...

example 3

Release Kinetic of Molsidomine from Polyacrylic Acid-Based Coating

[0060] Various solutions of molsidomine in volatile solvents are prepared and applied to balloon catheters by the methods indicated in Table I. In the “dip” application technique, each balloon catheter having a polyacrylic acid-based coating is dipped into its respective solution for 10 minutes. In the “pipet” application technique, 200 μl of solution is pipetted onto its respective coated balloon catheter while slowly turning. All samples are dried in an oven for 30 minutes at 50° C. and thereafter immersed in PBS (pH=7.4) to track the release of molsidomine over time. The cumulative amount of molsidomine released from each catheter yields the data shown in FIG. 5a and 5b.

TABLE IMolsidomine solution characterization, and methods ofapplying molsidomine solution to polymer coated catheters.Concentration (mgMolsidomine per mlApplicationSampleSolventsolvent)technique1chloroform150dip2chloroform30pipet3chloroform150pip...

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Abstract

A medical device, polymer composition, and method for delivering substantially water-insoluble drugs to tissue at desired locations within the body. At least a portion of the exterior surface of the medical device is provided with a polymer coating. Incorporated in the polymer coating is a solution of at least one substantially water-insoluble drug in a volatile organic solvent. The medical device is positioned to a desired target location within the body, whereupon the drug diffuses out of the polymer coating.

Description

[0001] This application is a continuation of co-pending application Ser. No. 09 / 172,026 filed Oct. 14, 1998, which is a continuation-in-part of co-pending application Ser. No. 09 / 133,603, filed Aug. 13,1998, which is a continuation-in-part of co-pending application Ser. No. 08 / 910,136, filed Aug. 13, 199.7, all of which are incorporated herein in their entirety by reference thereto.FIELD OF THE INVENTION [0002] The invention relates to methods and devices for the localized delivery of substantially water-insoluble drug agents within the body. BACKGROUND [0003] The systemic administration of drug agents, such as by transoral or intravenous means, treats the body as a whole even though the disease to be treated may be localized. In such a case, systemic administration may not be desirable because, for example, the drug agents may have unwanted effects on parts of the body which are not to be treated, or because treatment of the diseased part of the body requires a high concentration o...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61M25/10A61F2/06A61F2/82A61L27/54A61L29/08A61L29/16A61L31/10A61L31/16
CPCA61F2/82A61L27/34A61M2025/1088A61M2025/1081A61M2025/1075A61M2025/105A61M2025/0057A61L27/54A61L29/085A61L29/16A61L31/10A61L31/16A61L2300/222A61L2300/416A61L2300/45A61L2300/602A61L2300/604A61L2300/606A61M25/10A61M25/1027A61M29/02C08L75/04C08L67/04C08L33/08
Inventor BARRY, JAMES J.PALASIS, MARIA
Owner BOSTON SCI SCIMED INC
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