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Optimization of amino acid-stabilized erythropoietin parenteral formulation: In vitro and in vivo assessment Cover

Optimization of amino acid-stabilized erythropoietin parenteral formulation: In vitro and in vivo assessment

Open Access
|Mar 2016

References

  1. 1. S. Elliott, E. Pham and I. C. Macdougall, Erythropoietins: A common mechanism of action, Exp. Hematol.36 (2008) 1573–1584; DOI: 10.1016/j.exphem.2008.08.003.10.1016/j.exphem.2008.08.003
  2. 2. A. Sytkowski, L. Feldma and D. Zurbuch, Biological ability and structural stability of N-deglycosylated recombinant erythropoietin, Biochem. Biophys. Res. Commun.176 (1991) 698–704; DOI: 10.1016/S0006-291X(05)80240-2.10.1016/S0006-291X(05)80240-2
  3. 3. S. T. Koury, M. C. Bondurant and M. J. Koury, Localization of erythropoietin synthesizing cells in murine kidneys by in situ hybridization, Blood71 (1988) 524–527; DOI: 10.1038/ki.1993.115.10.1038/ki.1993.115
  4. 4. A. J. Erslev, Erythropoietin titers in health and disease, Semin. Hematol.28 (Suppl 3) (1991) 2–8.
  5. 5. C. Lacombe, J. L. Da Silva, P. Bruneval, J. G. Fournier, F. Wendling, N. Casadevall, J. P. Camilleri, J. Bariety, B. Varet and P. Tambourin, Peritubular cells are the site of erythropoietin synthesis in the murine hypoxic kidney, J. Clin. Invest.81 (1988) 620–623; DOI: 10.1172/JCI113363.10.1172/JCI113363
  6. 6. B. William, A. James and D. Pratt, Pharmacokinetics and pharmacodynamics of epoetin delta in two studies in healthy volunteers and two studies in patients with chronic kidney disease, Clin. Ther.29 (2007) 1368–1380; DOI: 10.1016/j.clinthera.2007.07.014.10.1016/j.clinthera.2007.07.014
  7. 7. S. Sifakis, E. Angelakis, E. Vardaki, Y. Koumantaki, I. Matalliotakis and E. Koumantakis, Erythropoietin in the treatment of iron deficiency anemia during pregnancy, Gynecol. Obstet. Invest. 51 (2001) 150–156; DOI: 10.1159/000052914.10.1159/000052914
  8. 8. P. Sabbatini, Strategies for optimizing hemoglobin response in cancer patients: focus on new epoetin alfa dosing regimens, EJC Suppl.2 (2004) 36–40; DOI: 10.1016/S1359–6349(03)00106-X10.1016/S1359-6349(03)00106-X
  9. 9. N. V. Sipsas, S. I. Kokori, J. P. A. Ioannidis, D. Kyriaki, A. G. Tzioufas and T. Kordossis, Circulating autoantibodies to erythropoietin are associated with human immunodeficiency virus type 1-related anemia, J. Infect. Des.180 (1999) 2044–2047; DOI: 10.1086/315156.10.1086/315156
  10. 10. J. F. Konings, J. M. Noppe, M. Mesnes and L. Jean, Improved cyclodextrin based erythropoietin formulation, WO Patent 1991011200 A1, Aug 8, 1991; ref. Chem. Abstr.139 (2003) 2074820 C.
  11. 11. K. C. Kwon, S. Y. Choi, Y. C. Kang, H. S. Jeh, S. J. Lee, M. J. Kim, J. E. Kim and J. S. Oh, Stable aqueous solution human erythropoietin not containing serum albumin, WO Patent 108152, December 16, 2004; ref. Chem. Abstr.141 (2004) 2528988 A1.
  12. 12. H. Woog, W. Gruber, H. J. Markl and F. Demmer, Stabilized erythropoietin preparations, U.S. Patent. 4992419, Feb 12, 1991; ref. Chem. Abstr.120 (1994) 1330301 C.
  13. 13. T. Kawaguchi and N. Shimoda, Stable erythropoietin preparation and process for formulating the same, U. S. Patent 4,806,524, Feb 21, 1989; ref. Chem. Abstr.111 (1989) 1258629 A1.
  14. 14. T. Kawaguchi and N. Shimoda, Method and composition for preventing the adsorption of a medicine, U. S. Patent 4,879,272, Nov 7, 1989; ref. Chem. Abstr.111 (1989) 1258628 A1.
  15. 15. F. J. Konings, M. J. Noppe and J. L. Mesens, Cyclodextrin based erythropoietin formulation, U.S. Patent 5,376,632, December 27, 1994; ref. Chem. Abstr.114 (1991) 2074820 A1.
  16. 16. T. W. Strickland, Stable and preserved erythropoietin compositions, U.S. Patent 5,661,125, August 26, 1997.
  17. 17. T. Yamazaki, T. Morita and H. Nagai, Erythropoietin solution preparation, U.S. Patent 6,277,367, August 21, 2001.
  18. 18. M. M. Bradford, A rapid and sensitive method for the quantitation of microgram quantities of protein utilizing the principle of protein – dye binding, Anal. Biochem.72 (1976) 248–254; DOI: 10.1016/0003-2697(76)90527-3.10.1016/0003-2697(76)90527-3
  19. 19. T. Marshall, Sodium dodecyl sulfate polyacrylamide gel electrophoresis of serum after protein denaturation in the presence or absence of 2-mercaptoethanol, Clin. Chem.30 (1984) 475–479.10.1093/clinchem/30.3.475
  20. 20. European Pharmacopeia, 5th ed., Strasbourg 2005, pp. 3494–3498.10.2175/193864705783865965
  21. 21. J. O. Hess and C. Schumann, Erythropoietin liquid formulation, U. S. Patent 7,767,644, August 3, 2010; ref. Chem. Abstr.157 (2012) 2558985 C.
  22. 22. T. W. Randolph and L. S. Jones, Surfactant-protein interactions, Pharm. Biotechnol.13 (2002) 159–175.10.1007/978-1-4615-0557-0_7
  23. 23. J. Chen and E. Dickinson, Protein/surfactant interfacial interactions Part 3. Competitive adsorption of protein + surfactant in emulsions, Colloid Surface A101 (1995) 77–85; DOI: 10.1016/0927-7757(95)03206-S.10.1016/0927-7757(95)03206-S
  24. 24. C. B. Youan, A. Hussain and N. T. Nguyen, Evaluation of sucrose esters as alternative surfactants in microencapsulation of proteins by the solvent evaporation method, AAPS PharmSci.5 (2003); DOI: 10.1208/ps050222.10.1208/ps050222275152912866947
  25. 25. E. Mori and B. Jirgensons, Effect of long-chain alkyl sulfate binding on circular dichroism and conformation of soybean trypsin inhibitor, Biochemistry20 (1981) 1630–1634; DOI: 10.1021/bi00509a034.10.1021/bi00509a0346784755
  26. 26. W. K. Cheung, J. Natarajan, M. Sanders, E. Vercammen, S. Begum and B. Shamara, Pharmaceutical composition of erythropoietin, U. S. Patent 248,797, December 9, 2004; ref. Chem. Abstr.133 (2000) 2369444 A1.
  27. 27. K. Kwon, S. Choi, Y. Kang, H. Jeh, S. Lee, M. Kim, J. Kim and J-S. Oh, Stable aqueous solution of human erythropoietin, not containing serum albumin, U. S. Patent 293419, December 20, 2007; ref. Chem. Abstr.141 (2004) 2528988 A1.
DOI: https://doi.org/10.1515/acph-2016-0007 | Journal eISSN: 1846-9558 | Journal ISSN: 1330-0075
Language: English
Page range: 69 - 82
Accepted on: Sep 28, 2015
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Published on: Mar 7, 2016
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year
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© 2016 Bahgat E. Fayed, Abdulkader F. Tawfik, Alaa Eldeen B. Yassin, published by Croatian Pharmaceutical Society
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.