Biodistribution and predictive hepatic gene expression of intravenous iron sucrose

Journal of Pharmacological and Toxicological Methods

Volumn 68, Issue 3, 2013, Pages 374-383

  Elford, Peter ^a   Bouchard, Johanne ^b   Jaillet, Léonore ^b   Pearson, Nick ^b   Rogue, Alexandra ^b   Sabadie, Caroline ^b   Forster, Roy ^b  

^a Azad Pharma AG   (Switzerland)

^b SOLVO BIOTECHNOLOGY   (Hungary)

Author keywords

Anemia; Biodistribution; Hepatic gene expression; Iron sucrose; Partitioning; Predictive toxicity; Rats

Indexed keywords

GENERIC DRUG; IRON SACCHARATE; MESSENGER RNA; TRANSFERRIN;

ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; BONE MARROW; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG DISTRIBUTION; DRUG LIVER LEVEL; DRUG TISSUE LEVEL; GENE EXPRESSION; GENETIC TRANSCRIPTION; IN VIVO STUDY; KIDNEY; LIVER; MALE; MASS SPECTROMETRY; MICROARRAY ANALYSIS; NONHUMAN; RAT; SINGLE DRUG DOSE; SPLEEN; SPRAGUE DAWLEY RAT; TISSUE DISTRIBUTION;

ANIMALIA; RATTUS;

ANEMIA; BIODISTRIBUTION; CS; EMA; EUROPEAN MEDICINES AGENCY; HEPATIC GENE EXPRESSION; ICP-MS; INDUCED COUPLED PLASMA TANDEM MASS SPECTROMETRY; IRON SUCROSE; IRON SUCROSE AZAD; ISA; KEGG; KYOTO ENCYCLOPEDIA OF GENES AND GENOMES; NACL; PARTITIONING; PREDICTIVE TOXICITY; RATS; STERILE ISOTONIC SALINE SOLUTION; TIBC; TOTAL IRON BINDING CAPACITY; TRANSFERRIN SATURATION;

ANIMALS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUGS, GENERIC; FERRIC COMPOUNDS; GENE EXPRESSION REGULATION; GLUCARIC ACID; HEMATINICS; INJECTIONS, INTRAVENOUS; MALE; MASS SPECTROMETRY; PRINCIPAL COMPONENT ANALYSIS; RATS; RATS, SPRAGUE-DAWLEY; TIME FACTORS; TISSUE DISTRIBUTION;

EID: 84886378365     PISSN: 10568719     EISSN: 1873488X     Source Type: Journal    
DOI: 10.1016/j.vascn.2013.04.005     Document Type: Article

References (25)

1. Bouchard J., Sabadie C., Decorde J., Jaillet L., Forster R., Elford P. ICP-MS determination of tissue iron levels in the rat. The Toxicologist 2013, March, 132(1):252. (Abstract 1178).
2. Chandler G., Harchowal J., Macdougall I.C. Intravenous iron sucrose: Establishing a safe dose. American Journal of Kidney Diseases 2001, 38:988-991.
3. Danielson B.G. Structure, chemistry and pharmacokinetics of intravenous iron agents. Journal of the American Society of Nephrology 2004, 15:93-98.
4. Danielson B.G., Salmonson T., Derendorf H., Geisser P. Pharmacokinetics of iron (lll)-hydroxide sucrose complex after a single intravenous dose in healthy volunteers. Arzneimittel-Forschung 1996, 46:615-621.
5. Espósito B.P., Breuer W., Slotki I., Cabantchik Z.I. Labile iron in parenteral iron formulations and its potential for generating plasma nontransferrin-bound iron in dialysis patients. European Journal of Clinical Investigation 2002, 32(Suppl. 1):42-49.
6. European Medicines Agency Reflection paper on non-clinical studies for generic nanoparticle iron medicinal product applications. London Available from. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105048.pdf.
7. European Medicines Agency (EMA) Guideline on bioanalytical method validation 2011, 21 July, (EMEA/CHMP/EWP/192217/2009).
8. Food, Drug Administration-Center for Drug Evaluation, Research Application Number:21-35. Pharmacology Review of NDA for Venofer® 2000, August 6th.
9. Forster R., Marchetti M.L., Monzani M.V. Problems in the application of toxicokinetics: Studies of ferric iron complexes. European Bulletin of Drug Research 1994, 3:151-157.
10. Geisser P., Burckhardt S. The pharmacokinetics and pharmacodynamics of iron preparations. Pharmaceutics 2011, 3:12-33.
11. Guz G., Glorieux G.L., De Smet R., Waterloos M-A F., Vanholder R.C., Dhont A.W. Impact of iron sucrose therapy on leucocyte surface molecules and reactive oxygen species in haemodialysis patients. Nephrology, Dialysis, Transplantation 2006, 21:2834-2840.
12. Hegde N.V., Unger E.L., Jensen G.L., Hankey P.A., Paulson R.F. Interrelationships between tissue iron status and erythropoiesis during postweaning development following neonatal iron deficiency in rats. American Journal of Physiology. Gastrointestinal and Liver Physiology 2010, 30 December, 300:G470-G476. (First published). 10.1152/ajpgi.00463.2010.
13. Kudasheva D.S., Lai J., Ulman A., Cowman M.K. Structure of carbohydrate-bound polynuclear iron oxyhydroxide nanoparticles in parenteral formulations. Journal of Inorganic Biochemistry 2004, 98:1757-1769.
14. Macdougall I.C., Tucker B., Thompson J., Tomson C.R., Baker L.R., Raine A.E. A randomized controlled study of iron supplementation in patients treated with erythropoietin. Kidney International 1996, 50:1694-1699.
15. Meier T., Schropp P., Pater C., Leoni A.-L., Khov-Tran V.V., Elford P. Physicochemical and toxicological characterization of a new generic iron sucrose preparation. Arzneimittel-Forschung 2011, 61:112-119.
16. Moon M.S., McDevitt E.I., Zhu J., Stanley B., Krzeminski J., Amin S., et al. Elevated hepatic iron activates NF-E2-related factor 2-regulated pathway in a dietary iron overload mouse model. Toxicological Sciences 2012, 129:74-85.
17. Pai A.B., Boyd A.V., McQuade C.R., Harford A., Norenberg J.P., Zager P.G. Comparison of oxidative stress markers after intravenous administration of iron dextran, sodium ferric gluconate and iron sucrose in patients undergoing hemodialysis. Pharmacotherapy 2007, 27:343-350.
18. Parkkinen J., von Bonsdorff L., Peltonen S., Grönhagen-Riska C., Rosenlöf K. Catalytically active iron and bacterial growth in serum of haemodialysis patients after i.v. iron-saccharate administration. Nephrology, Dialysis, Transplantation 2000, 15:1827-1834.
19. Schiesser D., Binet I., Tsinalis D., Dickenmann M., Keusch G., Schmidli M., et al. Weekly low-dose treatment with intravenous iron sucrose maintains iron status and decreases epoetin requirements in iron-replete haemodialysis patients. Nephrology, Dialysis, Transplantation 2006, 21:2841-2845.
20. Toblli J., Cao G., Oliveri L., Angerosa M. Comparison of oxidative stress and inflammation induced by different intravenous iron sucrose similar preparations in a rat model. Inflammation & Allergy Drug Targets 2012, 11:66-78.
21. Toblli J., Cao G., Giani J., Dominici F., Angerosa M. Different effects of European iron sucrose similar preparations and originator iron sucrose on nitrosative stress, apoptosis, oxidative stress, biochemical and inflammatory markers in rats. Clinical Kidney Journal 2011, 4(Suppl. 2). (Abstract SuO028).
22. Toblli J., Cao G., Oliveri L., Angerosa M. Differences between original intravenous iron sucrose complex Venofer® and the iron sucrose similar Generis® and potential implications. Portuguese Journal of Nephrology and Hypertension 2009, 23:53-63.
23. Toblli J., Cao G., Oliveri L., Angerosa M. Differences between original intravenous iron sucrose and iron sucrose similar preparations. Arzneimittel-Forschung 2009, 59:176-190.
24. Troadec M.B., Courselaud B., Détivaud L., Haziza-Pigeon C., Leroyer P., Brissot P., et al. Iron overload promotes Cyclin D1 expression and alters cell cycle in mouse hepatocytes. Journal of Hepatology 2006, Feb, 44(2):391-399.
25. Van Wyck D.B., Anderson J., Johnson K. Labile iron in parenteral iron formulations: A quantitative and comparative study. Nephrology, Dialysis, Transplantation 2004, 19:561-565.