揭开预灌封注射器针头堵塞的神秘面纱:通过创新技术探索崭新前景

IF 3.5 3区 医学 Q2 CHEMISTRY, MULTIDISCIPLINARY
Pharmaceutical Research Pub Date : 2024-03-01 Epub Date: 2024-02-07 DOI:10.1007/s11095-024-03673-7
Guangli Hu, Daniel Bonanno, Yongchao Su, Xi Zhao, Yogita Krishnamachari, William Forrest, Steven Persak, Jeffrey Givand, David Mannes, Margie Olbinado, Matthias Wagner, Christian Grünzweig, Vladimir Novak
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引用次数: 0

摘要

研究目的本研究旨在利用中子成像和同步辐射 X 射线断层扫描技术研究预灌封注射器针头区域的液体运动。目的是深入了解液体存在的动态,并了解导致针头堵塞的因素:方法:使用中子射线照相术和同步辐射 X 射线相位对比计算机断层扫描检查了扎针预灌封注射器。中子射线照相术提供了针头中液体存在的二维可视化,而同步辐射 X 射线断层扫描则提供了高分辨率的三维成像,以研究液体的详细形态特征:结果:中子射线照相术显示,在收到样品以及经过温度和压力循环后,针状区域存在液体。压力循环对液体形成的影响更为明显。同步辐射 X 射线断层扫描证实了液体的存在,并揭示了各种形态,包括不同大小的液滴、堵塞针切面的液体片段以及覆盖针壁的薄层。在钢针和玻璃管之间也观察到了液体的存在:中子成像和同步辐射 X 射线层析成像相结合,为了解预灌封注射器中的液体运动动态提供了宝贵的信息。研究发现,温度和压力循环有助于额外液体的形成,而压力变化则起着重要作用。详细的形态分析加深了对针内微结构排列的理解。这项研究有助于解决针头堵塞的问题,并可指导制定改善预灌封注射器性能的策略。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Unraveling Pre-filled Syringe Needle Clogging: Exploring a Fresh Outlook Through Innovative Techniques.

Objective: This study aimed to investigate the movement of liquid in the needle region of staked-in-needle pre-filled syringes using neutron imaging and synchrotron X-ray tomography. The objective was to gain insights into the dynamics of liquid presence and understand the factors contributing to needle clogging.

Methods: Staked-in-needle pre-filled syringes were examined using neutron radiography and synchrotron X-ray phase-contrast computed tomography. Neutron radiography provided a 2D visualization of liquid presence in the needle, while synchrotron X-ray tomography offered high-resolution 3D imaging to study detailed morphological features of the liquid.

Results: Neutron radiography revealed liquid presence in the needle region for as-received samples and after temperature and pressure cycling. Pressure cycling had a more pronounced effect on liquid formation. Synchrotron X-ray tomography confirmed the presence of liquid and revealed various morphologies, including droplets of different sizes, liquid segments blocking sections of the needle, and a thin layer covering the needle wall. Liquid presence was also observed between the steel needle and the glass barrel.

Conclusions: The combination of neutron imaging and synchrotron X-ray tomography provided valuable insights into the dynamics of liquid movement in staked-in-needle pre-filled syringes. Temperature and pressure cycling were found to contribute to additional liquid formation, with pressure changes playing a significant role. The detailed morphological analysis enhanced the understanding of microstructural arrangements within the needle. This research contributes to addressing the issue of needle clogging and can guide the development of strategies to improve pre-filled syringe performance.

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来源期刊
Pharmaceutical Research
Pharmaceutical Research 医学-化学综合
CiteScore
6.60
自引率
5.40%
发文量
276
审稿时长
3.4 months
期刊介绍: Pharmaceutical Research, an official journal of the American Association of Pharmaceutical Scientists, is committed to publishing novel research that is mechanism-based, hypothesis-driven and addresses significant issues in drug discovery, development and regulation. Current areas of interest include, but are not limited to: -(pre)formulation engineering and processing- computational biopharmaceutics- drug delivery and targeting- molecular biopharmaceutics and drug disposition (including cellular and molecular pharmacology)- pharmacokinetics, pharmacodynamics and pharmacogenetics. Research may involve nonclinical and clinical studies, and utilize both in vitro and in vivo approaches. Studies on small drug molecules, pharmaceutical solid materials (including biomaterials, polymers and nanoparticles) biotechnology products (including genes, peptides, proteins and vaccines), and genetically engineered cells are welcome.
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