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Pre-Clinical Investigation of Keratose as an Excipient of Drug Coated Balloons

Authors :
Claire V. Cawthon
Randolph L. Geary
Megan Erwin
Onree Wilson
Justin M. Saul
Emily Goel
Uwe Christians
Saami K. Yazdani
Thomas C. Register
Nathaniel Fedor
Trevor Rayl
Carson Schaff
Source :
Molecules, Volume 25, Issue 7, Molecules, Vol 25, Iss 1596, p 1596 (2020)
Publication Year :
2020
Publisher :
MDPI, 2020.

Abstract

Background: Drug-coated balloons (DCBs), which deliver anti-proliferative drugs with the aid of excipients, have emerged as a new endovascular therapy for the treatment of peripheral arterial disease. In this study, we evaluated the use of keratose (KOS) as a novel DCB-coating excipient to deliver and retain paclitaxel. Methods: A custom coating method was developed to deposit KOS and paclitaxel on uncoated angioplasty balloons. The retention of the KOS-paclitaxel coating, in comparison to a commercially available DCB, was evaluated using a novel vascular-motion simulating ex vivo flow model at 1 h and 3 days. Additionally, the locoregional biological response of the KOS-paclitaxel coating was evaluated in a rabbit ilio-femoral injury model at 14 days. Results: The KOS coating exhibited greater retention of the paclitaxel at 3 days under pulsatile conditions with vascular motion as compared to the commercially available DCB (14.89 &plusmn<br />4.12 ng/mg vs. 0.60 &plusmn<br />0.26 ng/mg, p = 0.018). Histological analysis of the KOS&ndash<br />paclitaxel-treated arteries demonstrated a significant reduction in neointimal thickness as compared to the uncoated balloons, KOS-only balloon and paclitaxel-only balloon. Conclusions: The ability to enhance drug delivery and retention in targeted arterial segments can ultimately improve clinical peripheral endovascular outcomes.

Details

Language :
English
ISSN :
14203049
Volume :
25
Issue :
7
Database :
OpenAIRE
Journal :
Molecules
Accession number :
edsair.doi.dedup.....5b0e7277f2c0f190a46af263d31b51b9