In vitro determination of drug transfer from drug-coated balloons.

Drug-coated balloons are medical devices designed to locally deliver drug to diseased segments of the vessel wall. For these dosage forms, drug transfer to the vessel wall needs to be examined in detail, since drug released into the blood is cleared from the site. In order to examine drug transfer,...

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Autores principales: Anne Seidlitz, Nadine Kotzan, Stefan Nagel, Thomas Reske, Niels Grabow, Claus Harder, Svea Petersen, Katrin Sternberg, Werner Weitschies
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Publicado: Public Library of Science (PLoS) 2013
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Acceso en línea:https://doaj.org/article/d1e4b1006ff54d6fa7b457549ceb7d2f
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spelling oai:doaj.org-article:d1e4b1006ff54d6fa7b457549ceb7d2f2021-11-18T08:39:28ZIn vitro determination of drug transfer from drug-coated balloons.1932-620310.1371/journal.pone.0083992https://doaj.org/article/d1e4b1006ff54d6fa7b457549ceb7d2f2013-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24391863/?tool=EBIhttps://doaj.org/toc/1932-6203Drug-coated balloons are medical devices designed to locally deliver drug to diseased segments of the vessel wall. For these dosage forms, drug transfer to the vessel wall needs to be examined in detail, since drug released into the blood is cleared from the site. In order to examine drug transfer, a new in vitro setup was developed combining the estimation of drug loss during advancement to the site of application in a model coronary artery pathway with a hydrogel compartment representing, as a very simplified model, the vessel wall. The transfer of fluorescent model substances as well as the drug paclitaxel from coated balloons to the simulated vessel wall was evaluated using this method. The model was suitable to quantify the fractions transferred to the hydrogel and also to qualitatively assess distribution patterns in the hydrogel film. In the case of fluorescein sodium, rhodamin b and paclitaxel, vast amounts of the coated substance were lost during the simulated passage and only very small fractions of about 1% of the total load were transferred to the gel. This must be attributed to good water solubility of the fluorescent substances and the mechanical instability of the paclitaxel coating. Transfer of the hydrophobic model substance triamterene was however nearly unaffected by the preliminary tracking procedure with transferred fractions ranging from 8% to 14%. Analysis of model substance distribution yielded inhomogeneous distributions indicating that the coating was not evenly distributed on the balloon surface and that a great fraction of the coating liquid did not penetrate the folds of the balloon. This finding is contradictory to the generally accepted assumption of a drug depot inside the folds and emphasizes the necessity to thoroughly characterize in vitro performance of drug-coated balloons to support the very promising clinical data.Anne SeidlitzNadine KotzanStefan NagelThomas ReskeNiels GrabowClaus HarderSvea PetersenKatrin SternbergWerner WeitschiesPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 8, Iss 12, p e83992 (2013)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Anne Seidlitz
Nadine Kotzan
Stefan Nagel
Thomas Reske
Niels Grabow
Claus Harder
Svea Petersen
Katrin Sternberg
Werner Weitschies
In vitro determination of drug transfer from drug-coated balloons.
description Drug-coated balloons are medical devices designed to locally deliver drug to diseased segments of the vessel wall. For these dosage forms, drug transfer to the vessel wall needs to be examined in detail, since drug released into the blood is cleared from the site. In order to examine drug transfer, a new in vitro setup was developed combining the estimation of drug loss during advancement to the site of application in a model coronary artery pathway with a hydrogel compartment representing, as a very simplified model, the vessel wall. The transfer of fluorescent model substances as well as the drug paclitaxel from coated balloons to the simulated vessel wall was evaluated using this method. The model was suitable to quantify the fractions transferred to the hydrogel and also to qualitatively assess distribution patterns in the hydrogel film. In the case of fluorescein sodium, rhodamin b and paclitaxel, vast amounts of the coated substance were lost during the simulated passage and only very small fractions of about 1% of the total load were transferred to the gel. This must be attributed to good water solubility of the fluorescent substances and the mechanical instability of the paclitaxel coating. Transfer of the hydrophobic model substance triamterene was however nearly unaffected by the preliminary tracking procedure with transferred fractions ranging from 8% to 14%. Analysis of model substance distribution yielded inhomogeneous distributions indicating that the coating was not evenly distributed on the balloon surface and that a great fraction of the coating liquid did not penetrate the folds of the balloon. This finding is contradictory to the generally accepted assumption of a drug depot inside the folds and emphasizes the necessity to thoroughly characterize in vitro performance of drug-coated balloons to support the very promising clinical data.
format article
author Anne Seidlitz
Nadine Kotzan
Stefan Nagel
Thomas Reske
Niels Grabow
Claus Harder
Svea Petersen
Katrin Sternberg
Werner Weitschies
author_facet Anne Seidlitz
Nadine Kotzan
Stefan Nagel
Thomas Reske
Niels Grabow
Claus Harder
Svea Petersen
Katrin Sternberg
Werner Weitschies
author_sort Anne Seidlitz
title In vitro determination of drug transfer from drug-coated balloons.
title_short In vitro determination of drug transfer from drug-coated balloons.
title_full In vitro determination of drug transfer from drug-coated balloons.
title_fullStr In vitro determination of drug transfer from drug-coated balloons.
title_full_unstemmed In vitro determination of drug transfer from drug-coated balloons.
title_sort in vitro determination of drug transfer from drug-coated balloons.
publisher Public Library of Science (PLoS)
publishDate 2013
url https://doaj.org/article/d1e4b1006ff54d6fa7b457549ceb7d2f
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AT thomasreske invitrodeterminationofdrugtransferfromdrugcoatedballoons
AT nielsgrabow invitrodeterminationofdrugtransferfromdrugcoatedballoons
AT clausharder invitrodeterminationofdrugtransferfromdrugcoatedballoons
AT sveapetersen invitrodeterminationofdrugtransferfromdrugcoatedballoons
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