Pre-dried drug delivery coating for use with a stent

a drug delivery and pre-dried technology, applied in the field of coatings, can solve the problems of oil utilization, unsatisfactory effects, and large doses of therapeutic agents, and achieve the effects of increasing the drying rate of the coating material, accelerating the transfer of solvent, and increasing the solvent evaporation ra

Inactive Publication Date: 2006-03-30
ATRIUM MEDICAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0055] The apparatus can also include a mechanism for agitating, mixing, stirring or otherwise replenishing the surface of coating substance to increases the rate of solvent evaporation. The mechanism accelerates the transfer of solvent to the surrounding environment. For ex

Problems solved by technology

However, there are drawbacks to systemic delivery of a therapeutic agent, one of which is that high concentrations of the therapeutic agent travels to all portions of the patient's body and can have undesired effects at areas not targeted for treatment by the therapeutic agent.
Furthermore, large doses of the therapeutic agent only amplify the undesired effects at non-target areas.
There is no discussion of any therapeutic benefit inherent in the silicone fluid itself, and there is no suggestion that other oils can be utilized to control the delivery of the antimicrobial agent
Although the '830 publication attempts to discuss every possible combination of delivery coating in combination with every drug or therapeutic agent that may have some utility in targeted delivery applications, there is no realization of the difficulty of using an oil for the controlled release of a therapeutic agent in a long term application.
A list of potential delivery vehicles identifies waxes and fats, however there is no indication that such vehicles can be utilized for anything other than a sho

Method used

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  • Pre-dried drug delivery coating for use with a stent
  • Pre-dried drug delivery coating for use with a stent
  • Pre-dried drug delivery coating for use with a stent

Examples

Experimental program
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Effect test

example 1

[0117] A fish oil:vitamin E coating was mixed at a ratio of 50:50.1.5 grams of this mixture was blended with 1.5 grams of ethanol. When placed in a bell jar vacuum (50 to 60 mTorr) in a weigh pan (19.63 cm2 area), it took 24 hours to completely remove the ethanol. When placed in a Petri dish (62.07 cm2 area), it took 4 hours to completely remove the ethanol under similar vacuum conditions. When the same formulation was placed in the rotating fixture (FIG. 6B) and the surface area was continually refreshed, it took 1 hour to remove the ethanol under similar vacuum conditions. The removal of ethanol was confirmed by FTIR.

example 2

[0118] A fish oil:vitamin E coating was mixed at a ratio of 50:50. 1.5 grams of this mixture was blended with 1.5 grams of nMP. When placed in a bell jar vacuum (50 to 60 mTorr) in a weigh pan (19.63 cm2 area), the nMP could not be removed even after 120 hours of vacuum. When placed in a Petri dish (62.07 cm2 area), it took 96 hours to completely remove the nMP under similar vacuum conditions. When the same formulation was placed in the rotating fixture (FIG. 6B) and the surface area was continually refreshed, it took 30 hours to remove the nMP under similar vacuum conditions. The removal of NMP was confirmed by FTIR.

example 3

[0119] A 30:70 fish oil:vitamin E formulation was prepared. A rapamycin pro-drug was dissolved in ethanol and 1.9169 grams of the drug solution was added to 1.0751 grams of the coating formulation. This mixture was placed in the rotating fixture (FIG. 6B) and the surface area was continually refreshed. The final drug concentration was 24.26% and was confirmed by HPLC analysis. The ethanol solvent was completely removed after 24 hours of operation. The removal of the ethanol was confirmed by FTIR analysis.

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Abstract

A method and apparatus for the provision of a coating for application to a medical device results in a medical device having a bio-absorbable coating. The coating includes a bio-absorbable carrier component. In addition to the bio-absorbable carrier component, a therapeutic agent component and solvent can also be provided. The solvent is removed from the coating before the coating is applied to the medical device. The coated medical device is implantable in a patient to effect controlled delivery of the coating, including the therapeutic agent, to the patient.

Description

RELATED APPLICATION [0001] This application claims priority to, and the benefit of, co-pending U.S. Provisional Application No. 60 / 613745, filed Sep. 28, 2004, for all subject matter common to both applications. The disclosure of said provisional application is hereby incorporated herein by reference in its entirety. This application also relates to co-pending U.S. patent application Ser. No. 10 / ______ (Attorney Docket No. ATA-426), filed concurrently with this application on September 28, 2005. FIELD OF THE INVENTION [0002] The present invention relates to coatings suitable for application to medical devices for delivery of one or more biologically active agents, and more particularly to a bio-absorbable coating in which solvent is removed before the coating material is applied to the medical devices, and an apparatus and method for removing solvent from the coating material. BACKGROUND OF THE INVENTION [0003] Therapeutic agents may be delivered to a targeted location in a human ut...

Claims

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Application Information

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IPC IPC(8): A61F2/00A61F2/82A61F2/86
CPCA61F2/82A61L31/148A61F2250/0067A61K47/10A61K47/22A61K47/44A61L31/08A61L31/10A61L31/16A61L2300/22A61L2300/416A61L2300/428A61L2300/45A61L2300/606A61L2300/802A61L2420/02A61M25/0009A61M25/0045A61F2/86A61P3/00A61P7/02A61P29/00A61P35/00
Inventor LABRECQUE, ROGERMOODIE, GEOFFREYFERRARO, JOSEPHROGERS, LISAMARTAKOS, PAULKARWOSKI, THEODOREHERWECK, STEVE A.CONROY, SUZANNESUNTER, BRIANHENRICH, GEORGETTE
Owner ATRIUM MEDICAL
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