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


CONCLUSIONS
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.
Department of Medical Chemistry, Medical University of Vienna , Vienna , Austria.
Monika
M
Praschberger
Carolin
C
Cornelius
Markus
M
Schitegg
Hans
H
Goldenberg
Barbara
B
Scheiber-Mojdehkar
Brigitte
B
Sturm
D018798:Anemia, Iron-Deficiency / Q000188:drug therapy*; D001682:Biological Availability; D018929:Cell Culture Techniques; D004305:Dose-Response Relationship, Drug; D065546:Drug Liberation; D004355:Drug Stability; D016568:Drugs, Generic / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry* / Q000378:metabolism; D004797:Enzyme-Linked Immunosorbent Assay; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry* / Q000378:metabolism; D000077605:Ferric Oxide, Saccharated; D005293:Ferritins / Q000378:metabolism; D005937:Glucaric Acid; D056945:Hep G2 Cells; D006801:Humans; D007275:Injections, Intravenous; D008264:Macrophages / Q000187:drug effects / Q000378:metabolism; D013054:Spectrophotometry, Atomic; D013395:Sucrose / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry* / Q000378:metabolism
D016568:Drugs, Generic; D005290:Ferric Compounds; D013395:Sucrose; D005293:Ferritins; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid
Bioavailability; biological stability; generic intravenous iron; iron sucrose; iron uptake; oxidative stress