Evidence map›Paper›PMID 24391863›Full record

ArticlePloS one2013

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

Anne Seidlitz, Nadine Kotzan, Stefan Nagel, Thomas Reske, Niels Grabow, Claus Harder, Svea Petersen, Katrin Sternberg, Werner Weitschies

Abstract read
In one paragraph

Article in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Effect of Drug-Coated Balloon in Side Branch Protection forFrontiers in cardiovascular medicine · 2021
    Pooled it
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Unveiling the population genetic structure of Iranian horses breeds by whole-genome resequencing analysis.Mammalian genome : official journal of the International Mammalian Genome Society · 2024
    Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Necrotic leg ulcers secondary to hydrophilic polymer gel emboli.Journal of vascular surgery cases and innovative techniques · 2019
    Article
  17. Frontiers in pharmacology · 2018
    Article
  18. HPLC-MS/MS method for quantification of paclitaxel from keratin containing samples.Journal of pharmaceutical and biomedical analysis · 2017
    Article
  19. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Anne SeidlitzInstitute of Pharmacy, Center of Drug Absorption and Transport, University of Greifswald, Greifswald, Germany.
Nadine KotzanInstitute of Pharmacy, Center of Drug Absorption and Transport, University of Greifswald, Greifswald, Germany.
Stefan NagelInstitute of Pharmacy, Center of Drug Absorption and Transport, University of Greifswald, Greifswald, Germany.
Thomas ReskeInstitute for Biomedical Engineering, University of Rostock, Rostock, Germany.
Niels GrabowInstitute for Biomedical Engineering, University of Rostock, Rostock, Germany.
Claus HarderBiotronik SE & Co. KG, Erlangen, Germany.
Svea PetersenInstitute for Biomedical Engineering, University of Rostock, Rostock, Germany.
Katrin SternbergInstitute for Biomedical Engineering, University of Rostock, Rostock, Germany.
Werner WeitschiesInstitute of Pharmacy, Center of Drug Absorption and Transport, University of Greifswald, Greifswald, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Coated Materials, BiocompatibleDrug Delivery SystemsAngioplasty, BalloonComputer SimulationCoronary VesselsHumansHydrogel, Polyethylene Glycol DimethacrylatePaclitaxelCoated Materials, BiocompatibleHydrogel, Polyethylene Glycol DimethacrylatePaclitaxel

Identifiers

PMID24391863
PMCPMC3877149

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.