Bioavailability and stability of intravenous iron sucrose originator versus generic iron sucrose AZAD

Abstract

Context: Severe iron deficiency requires intravenous iron supplementation to replenish iron stores. Intravenous iron sucrose has been used for decades for the treatment of anemia. New generic iron sucrose products are now marketed for the use in several countries and there is an ongoing discussion about the safety and efficacy of iron sucrose similars.

Objective: In this study, we compared the iron sucrose originator Venofer® and the generic iron sucrose AZAD (ISA) regarding bioavailability, toxicity and stability in human THP-1 cells and HepG2 cells.

Methods: The bioavailability of Venofer® and ISA was investigated in both cell types by a ferrozin-based assay. The release of incorporated iron was assayed by atomic absorption spectroscopy. Ferritin content was measured by enzyme-linked immunosorbent assay (ELISA). HepG2 cells were used to investigate the intracellular labile iron pool (LIP), which was measured by the fluorescent calcein assay. The amount of redox-active iron within the iron formulations was assayed using fluorescent dichlorofluorescein.

Results: We found no significant differences in all parameters between Venofer® and ISA in regard of bioavailability, toxicity and stability in vitro.

Discussion: ISA shows identical physico-chemical features and identical bioavailability in vitro. This study is a profound basis for future clinical tests with generic iron sucrose compounds.

• Bioavailability
• biological stability
• generic intravenous iron
• iron sucrose
• iron uptake
• oxidative stress

Declaration of interest

The study was funded by Azad Pharma AG. The funders had no role in data collection, analysis and interpretation of the data, decision to publish, or preparation of the manuscript. All authors declare no competing interest. This work was also supported by a FFG grant (Barbara Scheiber-Mojdehkar, TALENTE, No. 2441987-1).