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


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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.2008.08.003Search in Google Scholar

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)80240-2Search in Google Scholar

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.1993.115Search in Google Scholar

4. A. J. Erslev, Erythropoietin titers in health and disease, Semin. Hematol.28 (Suppl 3) (1991) 2–8.Search in Google Scholar

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/JCI113363Search in Google Scholar

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.2007.07.014Search in Google Scholar

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: 10.1159/000052914.10.1159/000052914Search in Google Scholar

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-XSearch in Google Scholar

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: 10.1086/315156.10.1086/315156Search in Google Scholar

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.Search in Google Scholar

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.Search in Google Scholar

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.Search in Google Scholar

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.Search in Google Scholar

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.Search in Google Scholar

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.Search in Google Scholar

16. T. W. Strickland, Stable and preserved erythropoietin compositions, U.S. Patent 5,661,125, August 26, 1997.Search in Google Scholar

17. T. Yamazaki, T. Morita and H. Nagai, Erythropoietin solution preparation, U.S. Patent 6,277,367, August 21, 2001.Search in Google Scholar

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)90527-3Search in Google Scholar

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/30.3.475Search in Google Scholar

20. European Pharmacopeia, 5th ed., Strasbourg 2005, pp. 3494–3498.10.2175/193864705783865965Search in Google Scholar

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.Search in Google Scholar

22. T. W. Randolph and L. S. Jones, Surfactant-protein interactions, Pharm. Biotechnol.13 (2002) 159–175.10.1007/978-1-4615-0557-0_7Search in Google Scholar

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-SSearch in Google Scholar

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/ps050222275152912866947Search in Google Scholar

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/bi00509a0346784755Search in Google Scholar

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.Search in Google Scholar

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.Search in Google Scholar

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