Vifor Pharma Group, Vifor Pharma Management Ltd.
Section of Pharmaceutical Sciences, School of Pharmaceutical Sciences of Western Switzerland (ISPSO), University of Geneva.
J Vis Exp. 2023 Jul 7(197). doi: 10.3791/63820.
Intravenously administered iron-carbohydrate nanoparticle complexes are widely used to treat iron deficiency. This class includes several structurally heterogeneous nanoparticle complexes, which exhibit varying sensitivity to the conditions required for the methodologies available to physicochemically characterize these agents. Currently, the critical quality attributes of iron-carbohydrate complexes have not been fully established. Dynamic light scattering (DLS) has emerged as a fundamental method to determine intact particle size and distribution. However, challenges still remain regarding the standardization of methodologies across laboratories, specific modifications required for individual iron-carbohydrate products, and how the size distribution can be best described. Importantly, the diluent and serial dilutions used must be standardized. The wide variance in approaches for sample preparation and data reporting limit the use of DLS for the comparison of iron-carbohydrate agents. Herein, we detail a robust and easily reproducible protocol to measure the size and size distribution of the iron-carbohydrate complex, iron sucrose, using the Z-average and polydispersity index.
静脉内给予的铁-碳水化合物纳米颗粒复合物被广泛用于治疗缺铁症。这一类包括几种结构上不同的纳米颗粒复合物，它们对用于物理化学特性这些药物的方法所需的条件的敏感性不同。目前，铁-碳水化合物复合物的关键质量属性尚未完全确定。动态光散射（DLS）已成为确定完整颗粒大小和分布的基本方法。然而，在实验室之间方法标准化、个别铁-碳水化合物产品所需的具体修改以及如何最好地描述尺寸分布方面仍然存在挑战。重要的是，必须标准化稀释剂和连续稀释。用于样品制备和数据报告的方法差异很大，限制了 DLS 用于比较铁-碳水化合物药物。本文详细介绍了一种使用 Z 均数和多分散指数测量铁-蔗糖碳水化合物复合物大小和大小分布的稳健且易于重现的方案。
