Di Francesco Tiziana, Philipp Erik, Borchard Gerrit
School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Geneva, Switzerland.
Vifor (International) AG, St. Gallen, Switzerland.
Ann N Y Acad Sci. 2017 Nov;1407(1):63-74. doi: 10.1111/nyas.13517.
Iron sucrose (IS) is a complex nanocolloidal intravenous suspension used in the treatment of iron-deficiency anemia. Follow-on IS products (iron sucrose similars (ISSs)) have obtained marketing authorization by the generic pathway, implying that identical copies of IS may be manufactured. However, recent prospective and retrospective clinical studies showed discrepancies in clinical outcomes, which might be related to differences in physicochemical properties. The aim of this work is to measure and compare the physicochemical properties of IS and three ISSs available in the market using innovative analytical procedures. The comprehensive elucidation of size, size distribution, morphology, and stability of these complex drugs revealed very significant differences between the products. This study serves to provide the basis to define critical quality attributes that may be linked to differences in clinical outcome and thus may contribute to an adequate regulatory approach for IS and its follow-on products.
蔗糖铁（IS）是一种用于治疗缺铁性贫血的复合纳米胶体静脉内悬浮液。后续的IS产品（蔗糖铁类似物（ISSs））已通过仿制药途径获得上市许可，这意味着可能会生产出IS的相同复制品。然而，最近的前瞻性和回顾性临床研究表明临床结果存在差异，这可能与物理化学性质的差异有关。这项工作的目的是使用创新的分析程序来测量和比较IS以及市场上三种可用的ISSs的物理化学性质。对这些复合药物的大小、大小分布、形态和稳定性的全面阐释揭示了产品之间非常显著的差异。本研究旨在为定义可能与临床结果差异相关的关键质量属性提供依据，从而可能有助于对IS及其后续产品采取适当的监管方法。
