Pneumatic tube transport of trastuzumab in IV bags -effect of headspace and surfactant on subvisible particle formation.

IF 3.7 3区 医学 Q2 CHEMISTRY, MEDICINAL Journal of pharmaceutical sciences Pub Date : 2025-01-08 DOI:10.1016/j.xphs.2024.12.003
Anna Kjellström, Ida Cederwall, Clàudia Sabaté Martinez, Stanley Kwok, Florian Rosenthal, Ulla Elofsson, Mattias Paulsson, Marie Wahlgren
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引用次数: 0

Abstract

In hospitals, IV bags can be prepared in advance for logistical and microbial safety reasons in a compounding unit and then transported to wards. Transport of protein drugs using a pneumatic tube system has been reported to result in high particle levels. In this study, pneumatic tube transport of trastuzumab in saline polyolefin bags was compared to delivery by hospital porters using an electric platform truck in an underground tunnel system. The transport was tracked using designed smart labels. Two strategies to prevent particle formation, removing headspace and adding the surfactant polysorbate 20 were evaluated. The transport by pneumatic tube had a higher level of shock and vibration than truck delivery. The total particle count measured using flow microscopy also increased more for pneumatic transport than for transport by vehicle. Removing the headspace decreased particle formation for both transports. Surfactant decreases particles over 10 µm for trastuzumab in saline IV bags but increases the total particle levels. Pneumatic tube transport of saline in polyolefin bags resulted in high particle levels and surfactant increased the total particle count. Removing headspace is a measure that can be incorporated into compounding practices to cover for inadequate surfactant levels in IV bags.

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来源期刊
CiteScore
7.30
自引率
13.20%
发文量
367
审稿时长
33 days
期刊介绍: The Journal of Pharmaceutical Sciences will publish original research papers, original research notes, invited topical reviews (including Minireviews), and editorial commentary and news. The area of focus shall be concepts in basic pharmaceutical science and such topics as chemical processing of pharmaceuticals, including crystallization, lyophilization, chemical stability of drugs, pharmacokinetics, biopharmaceutics, pharmacodynamics, pro-drug developments, metabolic disposition of bioactive agents, dosage form design, protein-peptide chemistry and biotechnology specifically as these relate to pharmaceutical technology, and targeted drug delivery.
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Higher concentration of trehalose dihydrate stabilizes recombinant IgG1 under forced stress conditions. Pneumatic tube transport of trastuzumab in IV bags -effect of headspace and surfactant on subvisible particle formation. Analytical Characterization of Aberrant Trisulfide Bond Formation in Therapeutic Proteins and Their Impact on Product Quality. Crystallization inhibition in molecular liquids by polymers above the overlap concentration (c*): Delay of the first nucleation event. Delaying the first nucleation event of amorphous solid dispersions above the polymer overlap concentration (c*): PVP and PVPVA in posaconazole.
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