Open AccessPerformance of Redox Active and Chelatable Iron Assays to Determine Labile Iron Release From Intravenous Iron Formulations
Author(s) -
Pai AB,
Meyer DE,
Bales BC,
Cotero VE,
Pai MP,
Zheng N,
Jiang W
Publication year - 2017
Publication title -
clinical and translational science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.303
H-Index - 44
eISSN - 1752-8062
pISSN - 1752-8054
DOI - 10.1111/cts.12443
Subject(s) - intravenous iron , bioequivalence , iron sucrose , chemistry , redox , in vitro , ferric , ferric iron , high performance liquid chromatography , chromatography , biochemistry , pharmacology , pharmacokinetics , iron deficiency , inorganic chemistry , ferrous , medicine , organic chemistry , anemia
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 matrices in vitro . The majority of published labile iron assays evaluated were not suitable for use in vitro due 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 use in vitro labile iron detection in a biorelevant matrix. Application of this method may enhance bioequivalence evaluation of generic i.v. iron formulations in the future.