Iron deficiency is an important subclinical disease affecting over one billion people worldwide. A growing body of clinical records supports the use of intravenous iron-carbohydrate complexes for patients where iron replenishment is necessary and oral iron supplements are either ineffective or cannot be tolerated by the gastrointestinal tract. A critical characteristic of iron-carbohydrate drugs is the complexity of their core-shell structure, which has led to differences in the efficacy and safety of various iron formulations. This review describes parameters influencing the safety and effectiveness of iron-carbohydrate complexes during production, storage, handling, and clinical application. We summarized the physicochemical and biological assessments of commercially available iron carbohydrate nanomedicines to provide an overview of publicly available data. Further, we reviewed studies that described how subtle differences in the manufacturing process of iron-carbohydrate complexes can impact on the physicochemical, biological, and clinical outcomes of original product versus their intended copies or so-called iron "similar" products.

中文翻译：

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影响静脉内碳水化合物铁纳米药物安全性和有效性的因素：从生产到临床实践。

铁缺乏症是一种重要的亚临床疾病，影响全世界超过十亿人。越来越多的临床记录支持在需要补铁且口服铁补充剂无效或胃肠道不能耐受的患者中使用静脉铁-碳水化合物复合物。碳水化合物铁药物的关键特征是其核-壳结构的复杂性，这导致了各种铁制剂的功效和安全性方面的差异。这篇综述描述了在生产，储存，处理和临床应用过程中影响铁水合物的安全性和有效性的参数。我们总结了市售铁碳水化合物纳米药物的理化和生物学评估，以提供公开数据的概述。此外，我们回顾了描述铁-碳水化合物复合物制造过程中的细微差异如何影响原始产品与其预期的复制品或所谓的铁“相似”产品的物理化学，生物学和临床结果的研究。