Differences in tissue distribution of iron from various clinically used intravenous iron complexes in fetal avian heart and liver.

Regulatory Toxicology and Pharmacology

Volumn 73, Issue 1, 2015, Pages 65-72

  Spicher, Karsten ^a   Brendler Schwaab, Susanne ^a   Schlösser, Christoph ^a   Catarinolo, Maria ^a   Fütterer, Sören ^b   Langguth, Peter ^b   Enzmann, Harald ^a  

^a Federal Institute for Drugs and Medical Devices Bundesinstitut für Arzneimittel und Medizinprodukte   (Germany)

^b JOHANNES GUTENBERG UNIVERSITY   (Germany)

Author keywords

Bioequivalence; CAM; Essential similarity; FCM; Generic medicine; IIC; IICs; Iron; IS; Nanomedicine; NBCDs; NM; NMs; Non biological complex drugs; Organotropy; SFG; Tissue distribution

Indexed keywords

FERRIC CARBOXYMALTOSE; FERRIC GLUCONATE; GENERIC DRUG; INTRAVENOUS IRON COMPLEX; IRON; IRON COMPLEX; IRON NANOPARTICLE; IRON SACCHARATE; UNCLASSIFIED DRUG; IRON DERIVATIVE;

ANIMAL TISSUE; ARTICLE; CONTROLLED STUDY; DRUG DISTRIBUTION; EMBRYO; FETUS; HEART; IRON BLOOD LEVEL; LIVER; NANOMEDICINE; NONHUMAN; PRIORITY JOURNAL; SENSITIVITY ANALYSIS; TISSUE DISTRIBUTION; ANIMAL; CHICKEN; INTRAVENOUS DRUG ADMINISTRATION; METABOLISM; PHYSIOLOGY; PROCEDURES; THERAPEUTIC EQUIVALENCE;

AVES;

ADMINISTRATION, INTRAVENOUS; ANIMALS; CHICKENS; DRUGS, GENERIC; HEART; IRON; IRON COMPOUNDS; LIVER; NANOMEDICINE; THERAPEUTIC EQUIVALENCY; TISSUE DISTRIBUTION;

EID: 84934296173     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2015.06.005     Document Type: Article

References (32)

1. Abeyrathne E., Lee H., Jo C., Nam K., Ahn D. Enzymatic hydrolysis of ovalbumin and the functional properties of the hydrolysates. Poult. Sci. 2014, 93:2678-2686.
2. Ai J., Biazar E., Jafarpour M., Montazeri M., Majdi A., Aminifard S., Zafari M., Akbari H.R., Rad H.G. Nanotoxicology and nanoparticle safety in biomedical designs. Int. J. Nanomed. 2011, 6:1117-1127.
3. Almeida J.P., Chen A.L., Foster A., Drezek R. Invivo biodistribution of nanoparticles. Nanomedicine 2011, 6:815-835.
4. Anirban G., Kohli H.S., Jha V., Gupta K.L., Sakhuja V. The comparative safety of various intravenous iron preparations in chronic kidney disease patients. Ren. Fail. 2008, 30:629-638.
5. Auerbach M., Ballard H. Clinical use of intravenous iron: administration, efficacy, and safety. Hematol. Am. Soc. Hematol. Educ. Program 2010, 2010:338-347.
6. Bishu K., Agarwal R. Acute injury with intravenous iron and concerns regarding long-term safety. Clin. J. Am. Soc. Nephrol. Sep. 2006, 1(Suppl.1):S19-23.
7. Borchard G., Flühmann B., Mühlebach S. Nanoparticle iron medicinal products - requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies. Regul. Toxicol. Pharmacol. 2012, 64:324-328.
8. EMA Reflection Paper on Non-clinical Studies for Generic Nanoparticle Iron Medicinal Product Applications 2011, EMA/CHMP/SWP/100094/2011. Last accessed May 12th 2015. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105048.pdf.
9. EMA Reflection Paper on the Data Requirements for Intravenous Liposomal Products Developed with Reference to an Innovator Liposomal Product 2013, EMA/CHMP/806058/2009/Rev. 02. Last accessed May 12th 2015. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/03/WC500140351.pdf.
10. EMA Reflection Paper on the Data Requirements for Intravenous Iron-based Nano-colloidal Products Developed with Reference to an Innovator Medicinal Product 2015, EMA/CHMP/SWP/620008/2012. Last accessed May 12th 2015. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/03/WC500184922.pdf.
11. Fütterer S., Andrusenko I., Kolb U., Hofmeister W., Langguth P. Structural characterization of iron oxide/hydroxide nanoparticles in nine different parenteral drugs for the treatment of iron deficiency anaemia by electron diffraction (ED) and X-ray powder diffraction (XRPD). J.Pharm. Biomed. Anal. 2013, 86:151-160.
12. Gasche C., Berstad A., Befrits R., Beglinger C., Dignass A., Erichsen K., Gomollon F., Hjortswang H., Koutroubakis I., Kulnigg S., Oldenburg B., Rampton D., Schroeder O., Stein J., Travis S., Van Assche G. Guidelines on the diagnosis and management of iron deficiency and anemia in inflammatory bowel diseases. Inflamm. Bowel Dis. 2007, 13:1545-1553.
13. Ghoti H., Rachmilewitz E.A., Simon-Lopez R., Gaber R., Katzir Z., Konen E., Kushnir T., Girelli D., Campostrini N., Fibach E., Goitein O. Evidence for tissue iron overload in long-term hemodialysis patients and the impact of withdrawing parenteral iron. Eur. J. Haematol. 2012, 89:87-93.
14. Gupta A., Zhuo J., Zha J., Reddy S., Olp J., Pai A. Effect of different intravenous iron preparations on lymphocyte intracellular reactive oxygen species generation and subpopulation survival. BMC Nephrol. 2010, 17:11-16.
15. Hayat A. Safety issues with intravenous iron products in the management of anemia in chronic kidney disease. Clin. Med. Res. 2008, 6:93-102.
16. Jahn M.R., Nawroth T., Fütterer S., Wolfrum U., Kolb U., Langguth P. Iron oxide/hydroxide nanoparticles with negatively charged shells show increased uptake in Caco-2 cells. Mol. Pharm. 2012, 9:1628-1637.
17. Kobayashi T., Tadokoro H., Matsumoto K. An autopsy case of secondary iron-overload cardiomyopathy. Intern Med. 2013, 52:1369-1373.
18. Kunzmann A., Andersson B., Thurnherr T., Krug H., Scheynius A., Fadeel B. Toxicology of engineered nanomaterials: focus on biocompatibility, biodistribution and biodegradation. Biochim. Biophys. Acta 2011, 1810:361-373.
19. Lee E.S., Park B.R., Kim J.S., Choi G.Y., Lee J.J., Lee I.S. Comparison of adverse event profile of intravenous iron sucrose and iron sucrose similar in postpartum and gynecologic operative patients. Curr. Med. Res. Opin. 2013, 29:141-147.
20. Ling D., Hyeon T. Chemical design of biocompatible iron oxide nanoparticles for medical applications. Small 2013, 9:1450-1466.
21. Liu G., Gao J., Ai H., Chen X. Applications and potential toxicity of magnetic iron oxide nanoparticles. Small 2013, 9:1533-1545.
22. Macdougall I.C. Evolution of iv iron compounds over the last century. J.Ren. Care 2009, 35(Suppl.2):8-13.
23. Romeis - Mikroskopische Technik 2010, Spektrum Akademischer Verlag, Heidelberg, 978-3-8278-1676-6. M. Mulisch, U. Welsch (Eds.).
24. Okam M.M., Mandell E., Hevelone N., Wentz R., Ross A., Abel G.A. Comparative rates of adverse events with different formulations of intravenous iron. Am. J. Hematol. 2012, 87:E123-E124.
25. Rebouche C.J., Wilcox C.L., Widness J.A. Microanalysis of non-heme iron in animal tissues. J.Biochem. Biophys. Methods Mar 31, 2004, 58:239-251.
26. Roth S., Langguth P., Spicher K., Enzmann H. Comparative toxicity and cell-tissue distribution study on nanoparticular iron complexes using avian embryos and HepG2-cells. Transl. Res. 2008, 151:36-44.
27. Schellekens H., Klinger E., Mühlebach S., Brin J.F., Storm G., Crommelin D.J. The therapeutic equivalence of complex drugs. Regul. Toxicol. Pharmacol. 2011, 59:176-183.
28. Stefánsson B.V., Haraldsson B., Nilsson U. Acute oxidative stress following intravenous iron injection in patients on chronic hemodialysis: a comparison of iron-sucrose and iron-dextran. Nephron Clin. Pract. 2011, 118:c249-c256.
29. Stein J., Dignass A., Chow K.U. Clinical case reports raise doubts about the therapeutic equivalence of an iron sucrose similar preparation compared with iron sucrose originator. Curr. Med. Res. Opin. 2012, 28:241-243.
30. Sturm B., Steinkellner H., Ternes N., Goldenberg H., Scheiber-Mojdehkar B. Invitro study on the effects of iron sucrose, ferric gluconate and iron dextran on redox-active iron and oxidative stress. Arzneimittelforschung 2010, 60:459-465.
31. Toblli J.E., Cao G., Oliveri L., Angerosa M. Comparison of oxidative stress and inflammation induced by different intravenous iron sucrose similar preparations in a rat model. Inflamm. Allergy Drug Targets 2012, 11:66-78.
32. Toblli J.E., Cao G., Olivieri L., Angerosa M. Comparison of the renal, cardiovascular and hepatic toxicity data of original intravenous iron compounds. Nephrol. Dial. Transpl. 2010, 25:3631-3640.