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Crystalline paclitaxel coated DES with bioactive protective layer development.

Shady Farah1, Abraham J Domb1

  • 1Institute of Drug Research, School of Pharmacy-Faculty of Medicine, Center for Nanoscience and Nanotechnology and The Alex Grass Center for Drug Design and Synthesis, The Hebrew University of Jerusalem, 91120, Israel.

Journal of Controlled Release : Official Journal of the Controlled Release Society
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Summary

Researchers developed a novel carrier-free drug-eluting stent (DES) using surface-crystallized paclitaxel (PT). This innovative approach offers a stable, controlled drug release for improved local delivery from implantable medical devices.

Keywords:
Bioactive coatingControlled multilayer-releaseCrystallizationDrug eluting stentsHyaluronic acidPaclitaxel

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Area of Science:

  • Biomaterials Science
  • Drug Delivery Systems
  • Cardiovascular Devices

Background:

  • Current drug-eluting stents (DES) utilize polymeric carriers, but clinical complications necessitate safer alternatives.
  • Previous work introduced carrier-free rapamycin-eluting stents.
  • This study explores paclitaxel (PT) crystallization for carrier-free DES.

Purpose of the Study:

  • To report the first surface crystallization of paclitaxel (PT) onto metallic stents for carrier-free drug-eluting stent (DES) fabrication.
  • To investigate the physicochemical principles and process parameters for controllable, homogeneous crystalline PT coatings.
  • To evaluate the drug release profile and mechanical stability of the developed PT-coated stents.

Main Methods:

  • Surface crystallization of paclitaxel (PT) onto metallic stent scaffolds.
  • Extensive study of crystallization principles and process parameters.
  • Fabrication of multilayer coatings with controlled thickness (4-7μm) and drug loading (~100μg PT).
  • In vitro drug release testing over 28 days.
  • Mechanical stability assessment using deployment and expansion simulations.
  • Investigation of fast-dissolving top coatings and bioactive top coatings for controlled release.

Main Results:

  • Achieved controllable and homogeneous crystalline paclitaxel coatings on stent scaffolds.
  • Developed stents with approximately 100μg PT and a 4-7μm multilayer coating.
  • Demonstrated constant in vitro PT release for at least 28 days, with 10% cumulative release.
  • Confirmed that a fast-dissolving top coating enhances mechanical stability during simulated deployment.
  • Explored bioactive top coatings for multilayer controlled release applications.

Conclusions:

  • Surface crystallization of paclitaxel offers a promising carrier-free approach for drug-eluting stents.
  • The developed coating exhibits stable, controlled drug release and improved mechanical stability.
  • This technology has broad applicability for local drug delivery from various implantable medical devices.