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影响油迁移和预装注射器中的生物物质的变量
Kayla Gentile1, Chengbin Huang1, Xiaoyang Liu1
1Analytical Enabling Capabilities, Analytical Research and Development, Merck & Co., Inc., 2000 Galloping Hill Rd., Kenilworth, NJ, 07033, USA.
预填注射器中的油可以迁移到药物产品中,影响颗粒形成和注射器功能. 这项研究揭示了注射器来源和配方影响油迁移,这对于药物开发和容器选择至关重要.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 材料科学 材料科学 材料科学
背景情况:
- 预填注射器 (PFS) 为患者提供了好处,但在油迁移方面面临着挑战.
- 油可以诱导颗粒的形成,并影响亲肠道药物产品中的注射器功能.
- 监管机构强调了解药物产品对油诱导的颗粒的敏感性.
研究的目的:
- 调查不同注射器来源和配方成分对油迁移的影响.
- 评估油对蛋白质聚合和预填注射器功能的影响.
- 为了降低亲肠道药物产品的初级容器封闭选择风险.
主要方法:
- 实验设计 (DOE) 研究油的迁移风险.
- 共振质量测量 (RMM) 和微流成像 (MFI) 用于粒子表征.
- 感应合等离子体质谱 (ICP-MS) 用于量化.
主要成果:
- 油的迁移受到注射器来源,化过程和表面活性剂特性的影响.
- 增加的蛋白质度和储存温度会增加破解和挤出力.
- 蛋白质的稳定性主要取决于分子性质,油的影响最小.
结论:
- 注射器的来源和配方是影响PFS中油迁移的关键因素.
- 了解这些相互作用对于最佳的初级容器选择和药物产品质量至关重要.
- 这种评估有助于减轻与制药产品中油相关的风险.
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