Utilizing Octanoic Acid to Quantitatively Assess the Oxidation Status of PS80.

IF 4.3 3区医学 Q2 CHEMISTRY, MULTIDISCIPLINARY

Pharmaceutical Research Pub Date : 2025-08-01 Epub Date: 2025-08-11 DOI:10.1007/s11095-025-03908-1

Yue Guo, Sisi Zhang, Jamie Ash, Stacey Helming, Rachel Mullen, Xuening Hu, Qingyan Hu, Jing Wang, Tse-Hong Chen, Shao-Chun Wang, Douglas Kamen, Biao Shen, Hui Xiao, Ning Li

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引用次数: 0

Abstract

Purpose: The study aims to address the gap in research concerning the stability of polysorbate (PS) in placebo samples, as opposed to drug products. While PS is a critical excipient in protein drug formulations, its stability in placebo samples has been less explored. Notably, PS in placebo samples is more susceptible to oxidation rather than hydrolysis, even at low temperatures like 5℃. The study seeks to provide a quantitative measure for PS oxidation, which has traditionally been described in vague terms.

Method: The research identified octanoic acid as an oxidative product of PS80, which can serve as a reliable marker for PS80 oxidation. This marker enables the detection of early signs of oxidation and facilitates a quantitative description of the oxidation status, regardless of the stress conditions and incubation times. The method's accuracy and precision were validated to be within 15%, aligning with industry standards.

Results: The use of octanoic acid as a marker successfully indicates the oxidation status of PS80, offering a quantitative approach to assess PS80 stability. This method provides a clearer understanding of the shelf-life of placebo products concerning PS80 stability.

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利用辛酸定量评价PS80氧化状态。

目的：本研究旨在解决关于安慰剂样品中聚山梨酸酯（PS）稳定性研究的空白，而不是药物产品。虽然PS是蛋白质药物配方中的重要赋形剂，但其在安慰剂样品中的稳定性研究较少。值得注意的是，即使在5℃这样的低温下，安慰剂样品中的PS也更容易被氧化而不是水解。该研究旨在为PS氧化提供定量测量，这在传统上被描述为模糊的术语。方法：本研究鉴定辛酸为PS80的氧化产物，辛酸可作为PS80氧化的可靠标志物。该标记能够检测氧化的早期迹象，并促进氧化状态的定量描述，而不考虑应激条件和孵育时间。验证了该方法的准确度和精密度在15%以内，符合行业标准。结果：利用辛酸作为标记物成功地指示了PS80的氧化状态，为评价PS80的稳定性提供了一种定量方法。该方法可以更清晰地了解与PS80稳定性相关的安慰剂产品的保质期。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

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.