Pneumatic tube transport of trastuzumab in IV bags—Effect of headspace and surfactant on subvisible particle formation

IF 3.8 3区 医学 Q2 CHEMISTRY, MEDICINAL Journal of pharmaceutical sciences Pub Date : 2025-02-01 DOI:10.1016/j.xphs.2024.12.003
Anna Kjellström , Ida Cederwall , Clàudia Sabaté Martínez , Stanley Kwok , Florian Rosenthal , Ulla Elofsson , Mattias Paulsson , Marie Wahlgren
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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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曲妥珠单抗在静脉输液袋中的气管输送——顶空和表面活性剂对不可见颗粒形成的影响。
在医院,出于后勤和微生物安全的原因,静脉注射袋可以提前准备好,然后运送到病房。据报道,使用气动管道系统运输蛋白质药物会导致高颗粒水平。在这项研究中,将曲妥珠单抗装在生理盐水聚烯烃袋中的气动管道运输与医院搬运工在地下隧道系统中使用电动平台卡车的运输进行了比较。运输使用设计的智能标签进行跟踪。评估了两种防止颗粒形成的策略,即去除顶空和添加表面活性剂聚山梨酯20。气动管道运输比卡车运输具有更高的冲击和振动水平。使用流动显微镜测量的总颗粒数在气动运输中也比在车辆运输中增加更多。去除顶空减少了两种运输的颗粒形成。表面活性剂减少曲妥珠单抗在生理盐水IV袋中超过10 μ m的颗粒,但增加总颗粒水平。在聚烯烃袋中气力输送生理盐水导致高颗粒水平,表面活性剂增加了总颗粒数。去除顶空是一项措施,可纳入复方做法,以掩盖静脉输液袋中表面活性剂水平不足。
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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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