Toxicity assessment of extracts from infusion sets in cEND brain endothelial cells

George R. Dakwar, Veronika Kaplun, Lena Kojukarov, Pavel Gorenbein, Ilana Schumacher, Diana Kontorovich, Carola Förster, Elie Beit-Yannai, David Stepensky

    Research output: Contribution to journalArticlepeer-review

    5 Scopus citations

    Abstract

    In vitro safety assessment of disposable medical devices, including infusion sets, is usually performed using L-929 mouse keratinocytes. However, cells of different origin (endothelial, lymphoid and myeloid cells) are also exposed to infusion sets' extractables during their clinical use. We studied whether the cEND mouse brain endothelial cells can be suitable for in vitro safety assessment of infusion sets. We analyzed infusion sets from different manufacturers that varied in design and storage time. cEND cells were incubated with extracts of individual parts of the infusion sets (tube, cup, latex), and relative toxicities were analyzed using MTT test, DCFH-DA-based analysis of reactive oxygen species formation, apoptosis and cell cycle analyses. We identified a pattern of yellowing of the infusion sets upon storage and revealed that it originated from the latex part. Extracts of the individual parts of the infusion sets, primarily of the latex, were toxic to the cEND cells leading to induction of apoptosis and cell death. We conclude that infusion sets release extractables that can be toxic to the endothelial cells of the patients that receive infusion. We suggest to use cEND cells for in vitro safety assessment of infusion sets and other medical devices that release extractables to the bloodstream.

    Original languageEnglish
    Pages (from-to)20-27
    Number of pages8
    JournalInternational Journal of Pharmaceutics
    Volume434
    Issue number1-2
    DOIs
    StatePublished - 15 Sep 2012

    Keywords

    • Disposable medical equipment
    • Infusion sets
    • Leachables and extractables
    • Safety
    • Shelf life

    ASJC Scopus subject areas

    • Pharmaceutical Science

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