Potential Sampling Errors in Stability Studies Due to Dead Volume in Closed System Transfer Devices.
Background: Closed system transfer devices (CSTD) help to reduce the exposure of healthcare professionals to hazardous drugs. They may be used in stability studies conducted on anticancer drugs. During a stability study about polyolefin bags of gemcitabine, Tevadaptor® device was suspected of causin...
| Published in: | Journal of Pharmacy Technology Vol. 40; no. 6; pp. 296 - 300 |
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| Main Authors: | , , , , , |
| Format: | research tables/charts Journal Article |
| Published: |
Sage Publications Inc.
Dec2024
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=180676485&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 180676485 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 87551225 G2J jtl: Journal of Pharmacy Technology issn: 87551225 maglogo: Y pubinfo: dt: Dec2024 vid: 40 iid: 6 pid: 344 pub: Sage Publications Inc. place: Thousand Oaks, California artinfo: ui: 180676485 180191302 180676485 180676485 10.1177/87551225241285319 180676485 ppf: 296 ppct: 4 formats: tig: atl: Potential Sampling Errors in Stability Studies Due to Dead Volume in Closed System Transfer Devices. aug: au: Closset, Mélanie Colsoul, Maire-Lise Bihin, Benoît Hecq, Jean-Daniel Odou, Pascal Galanti, Laurence affil: Medical Laboratory, CHU UCL NAMUR, Yvoir, Belgium sug: subj: Drug Compounding Methods Drug Compounding Equipment and Supplies Sampling Error Antineoplastic Agents Human Descriptive Statistics Data Analysis Software Chromatography, Liquid Confidence Intervals Biological Assay ab: Background: Closed system transfer devices (CSTD) help to reduce the exposure of healthcare professionals to hazardous drugs. They may be used in stability studies conducted on anticancer drugs. During a stability study about polyolefin bags of gemcitabine, Tevadaptor® device was suspected of causing a bias in the evaluation of the concentrations of the first aliquots extracted from the bags. Objective: The objectives are to determine whether the use of a CSTD to prepare a drug solution and to withdraw it from a bag can interfere on the measured concentration compared to the expected one and to suggest hypothesis to explain the phenomenon. Method: In the first experiment, three polyolefin bags of gemcitabine (5.4 mg/mL) were prepared under aseptic conditions using the Tevadaptor Luer Lock Adaptor®. The day of preparation, five aliquots of 3.8 ml each were sequentially withdrawn from each polyolefin bag using the same device. After one day, a new aliquot was withdrawn from each bag. In the second experiment, three polyolefin bags of gemcitabine (5.4 mg/ml) were prepared under aseptic conditions using a needle. One aliquot was extracted using a needle after the preparation from each bag, and another aliquot was extracted after one day. The concentrations of all aliquots were measured by liquid chromatography coupled to a photodiode array detector during the same run. Results and discussion: The concentrations of the first aliquots extracted on day zero from the polyolefin bags using the Tevadaptor Luer Lock Adaptor® exhibit an overestimation of 26% ([95%CI: 23%-29%] P<0.001) compared to the others. Overestimation is not found for subsequent aliquots, or while using a needle to bypass the Tevadaptor® device. Conclusion: This case highlights the bias that may arise when using CSTDs in stability studies. They should be used with comprehensive understanding of their technical specifications. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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