石英晶微平衡作为药物和建筑材料相互作用的预测工具,用于静脉注射蛋白质药物管理
Joseph Weidman1, Ligi Mathews2, Kedar Gokhale2
1Janssen Pharmaceuticals, A Johnson & Johnson Company 1400 McKean Rd, Lower Gwynedd Township, PA 19002, USA.
这项研究量化了IV给药期间蛋白质药物对常见聚合物的损失. 一个预测模型估计了药物和表面活性剂对PVC和PP等表面的吸附,这对于配方特性至关重要.
科学领域:
- 生物制药配方 生物制药配方
- 材料科学 材料科学 材料科学
- 分析化学 分析化学
背景情况:
- 基于蛋白质的治疗方法的不断发展需要彻底的配方表征.
- 了解药物表面相互作用对于在静脉注射 (IV) 期间确保准确的剂量至关重要.
研究的目的:
- 描述IgG药物产品及其助剂在聚合物表面 (PVC和PP) 上的吸附行为.
- 开发一种预测模型,用于估计在模拟静脉注射过程中蛋白质药物和表面活性剂的吸附和损失.
主要方法:
- 使用石水晶微平衡与分散监测 (QCM-D) 来研究IgG药物产品在PVC和PP表面的不同度 (0.0001-0.1 mg/mL) 的吸附.
- 描述药物配方,重点关注表面活性剂的行为,并分析单个成分的吸附.
- 在模拟输液中与蛋白质度测试相关联的传感图数据,以构建预测模型.
主要成果:
- 对IgG药物产品和表面活性剂在疏水性聚合物表面的量化吸附.
- 建立了一个初步的预测模型,将药物度与吸附和损失相关联.
- 药物成分在PVC和PP表面上显著吸附.
结论:
- 开发了一种可靠的方法来预测聚合物材料上的蛋白质药物吸附和剂量损失.
- 这些发现对于优化药物制品配方和确保准确的治疗输送至关重要.
- 这项研究为最大限度地减少聚合物输送系统中药物损失提供了基础.
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