Performance of Redox Active and Chelatable Iron Assays to Determine Labile Iron Release From Intravenous Iron Formulations.
Performance of Redox Active and Chelatable Iron Assays to Determine Labile Iron Release From Intravenous Iron Formulations.
复制标题
氧化还原活性铁和螯合铁测定的性能以确定静脉铁制剂中不稳定铁的释放。
DOI：
10.1111/cts.12443
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发表时间：
2017
期刊：
影响因子：
--
通讯作者：
Jiang,W
中科院分区：
文献类型：
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作者：
Pai,AB;Meyer,DE;Bales,BC;Cotero,VE;Pai,MP;Zheng,N;Jiang,W
来自美国以外的全球市场的新兴数据显示，非美国仿制药(静脉注射)铁制剂可能具有与参考上市药物(RLD)不同的铁释放曲线。第一支非专利静脉注射。2011年，美国批准的铁是葡萄糖酸铁钠络合物。我们评价了可螯合和氧化还原活性铁测定方法，以测量静脉注射释放的活性铁的量。生物悬浮剂基质中的铁制剂。由于静脉注射的压倒性干扰，大多数已发表的不稳定铁检测方法不适用于体外试验。铁制品。然而，一种优化的基于高效液相色谱(HPLC)的方法在生物分离基质中用于不稳定的铁检测时表现良好。该方法的应用可提高仿制药的生物等效性评价。铁的配方在未来。
Emerging data from global markets outside the United States, where many generic iron sucrose formulations are available, have revealed that non‐US generic intravenous (i.v.) iron formulations may have iron release profiles that differ from the reference listed drug (RLD). The first generic i.v. iron approved in the United States was sodium ferric gluconate complex in 2011. We evaluated chelatable and redox labile iron assay methods to measure the amount of labile iron released from i.v. iron formulations in biorelevant matricesin vitro. The majority of published labile iron assays evaluated were not suitable for usein vitrodue to overwhelming interference by the presence of the i.v. iron products. However, an optimized high‐performance liquid chromatography (HPLC)‐based method performed well for usein vitrolabile iron detection in a biorelevant matrix. Application of this method may enhance bioequivalence evaluation of generic i.v. iron formulations in the future.