Centrifuge siliconization of primary container systems

IF 3.8 3区 医学 Q2 CHEMISTRY, MEDICINAL Journal of pharmaceutical sciences Pub Date : 2025-03-01 Epub Date: 2025-01-30 DOI:10.1016/j.xphs.2025.01.025
Brian Wong , Kaitlin Wang , Kavin Kowsari, Yongchao Su, William Forrest, Jeffrey Givand, Guangli Hu
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Abstract

Pre-filled syringes (PFS) have been in use in the pharmaceutical industry for over 60 years. For syringe functionality, a layer of silicone oil is often added as lubrication to promote smooth plunger stopper movement. Importantly, current technologies that generate this silicone oil layer often produce inhomogeneous layers displaying topographical features such as dimples. Additionally, the equipment that generates these layers is generally inaccessible in non-commercial settings. Here, we present a new silicone oil coating technique that addresses the shortcomings of traditional methods to generate a uniform silicone oil layer utilizing commonplace centrifuge technology. Our method creates silicone layers in PFS with improved homogeneity and tunable thickness, ranging from 400–1800 nm, by adjusting centrifuge speed and temperature.
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主容器系统的离心硅化。
预充式注射器(PFS)在制药行业已经使用了60多年。对于注射器功能,通常添加一层硅油作为润滑,以促进平稳的柱塞塞运动。重要的是,目前产生这种硅油层的技术通常会产生不均匀的层,显示出诸如酒窝之类的地形特征。此外,产生这些层的设备通常在非商业环境中无法使用。本文提出了一种新的硅油涂层技术,解决了传统方法利用普通离心机技术生成均匀硅油层的缺点。我们的方法通过调节离心机速度和温度,在PFS中产生具有更好的均匀性和可调厚度的硅酮层,范围从200 -1400 nm。
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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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