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

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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 ± 4.12 ng/mg vs. 0.60 ± 0.26 ng/mg, p = 0.018). Histological analysis of the KOS–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.
subject
keratose
drug delivery
drug-coated balloon
contributor
Goel, E (author)
Erwin, M (author)
Cawthon, C.V. (author)
Yazdani, S. (author)
date
2020-09-09T15:28:37Z (accessioned)
2020-09-09T15:28:37Z (available)
2020-03-31 (issued)
identifier
Goel E, Erwin M, Cawthon CV, et al. Pre-Clinical Investigation of Keratose as an Excipient of Drug Coated Balloons. Molecules. 2020;25(7):1596. Published 2020 Mar 31. doi:10.3390/molecules25071596 (citation)
doi: 10.3390/molecules25071596. (doi)
http://hdl.handle.net/10339/96981 (uri)
language
en_US (iso)
publisher
MDPI
title
Pre-Clinical Investigation of Keratose as an Excipient of Drug Coated Balloons.
type
Article

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