900
Views
0
CrossRef citations to date
0
Altmetric
Laboratory Study

Aluminum in Erythropoietin Formulations: Lyophilized versus Liquid Forms

, , , , &
Pages 391-395 | Received 25 Sep 2012, Accepted 09 Dec 2012, Published online: 24 Jan 2013

REFERENCES

  • Pisoni RL, Bragg-Gresham JL, Young EW, Anemia management and outcomes from 12 countries in the dialysis outcomes and practice patterns study (DOPPS). Am J Kidney Dis. 2004;44(1):94–111.
  • United States Pharmacopeia, USP 32; 2008.
  • The Japanese Pharmacopoeia, Fifteenth Edition; 2009.
  • Shelby JE. Introduction to Glass Science and Technology. Cambridge: The Royal Society of Chemistry; 1997.
  • Smith EJ, Nash RJ. Elastomeric closures for parenterals. In: Avis KE, Lachman, L, Lieberman HA, eds. Pharmaceutical Dosage Forms: Parenteral Medications. Vol 2. New York: Marcel Dekker Inc; 1986:155–215.
  • Waterman KC, Adami RC. Accelerated aging: prediction of chemical stability of pharmaceuticals. Int J Pharm. 2005;293:101–125.
  • Bohrer D, Bertagnolli DC, de Oliveira SMR, do Nascimento PC, de Carvalho LM, Pomblum SG. Drugs as a hidden source of aluminium for chronic renal patientsNephrol Dial Transpl. 2007;22(2):605–611.
  • de Carvalho LM, Garmatz JC, Spengler C, Determination of metallic contaminants in human recombinant erythropoietin (EPO) formulations by adsorptive cathodic stripping voltammetry and UV photo-decomposition of samples. J Braz Chem Soc. 2010;21(4):701–709.
  • Bohrer D, do Nascimento PC, Martins P, Binotto R. Availability of aluminum from glass and an Al-form ion exchanger in the presence of complexing agents and amino acids. Anal Chim Acta. 2002;459:267–276.
  • Fleming LW, Halls DJ, Henderson IS, Mactier RA, Taylor JE, Stewart WK. Aluminium content of water for injection used with recombinant human erythropoietin. Nephrol Dial Transpl. 1991;6(11):857–861.
  • Bohrer D, do Nascimento PC, Binotto R, Becker E. Influence of the glass packing on the contamination of pharmaceutical products by aluminium. Part III: Interaction container-chemicals during heating for sterilisation. J Trace Elem Med Biol. 2003;17:107–115.
  • Nicolini M, Zatta P, Corain B. Aluminum in Chemistry, Biology, and Medicine. Verona: EditoraCortina International; 1991.
  • Garabed E, Adeera L, Nathan WL. Bone metabolism and disease in chronic kidney disease. Am J Kidney Dis. 2003;42(Suppl 3):1–201.
  • Sharma B, Bader F, Templeman T, Lisi P, Ryan M, Heavner GA. Technical investigations into the cause of the increased incidence of antibody-mediated pure red cell aplasia associated with EPREX®. Eur J Hosp Pharm. 2004;5:86–91.
  • Aguilar F, Autrup H, Barlow S, et al. Scientific opinion of the panel on food additives, flavouring, processing aids and food contact materials on a request from European Commission on safety of aluminium from dietary intake. EFSA J. 2008;754:1–34.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.