Optimization of amino acid-stabilized erythropoietin parenteral formulation: In vitro and in vivo assessment
References
- 1. S. Elliott, E. Pham and I. C. Macdougall, Erythropoietins: A common mechanism of action,(2008) 1573–1584; DOI: 10.1016/j.exphem.2008.08.003.
- 2. A. Sytkowski, L. Feldma and D. Zurbuch, Biological ability and structural stability of N-deglycosylated recombinant erythropoietin,(1991) 698–704; DOI: 10.1016/S0006-291X(05)80240-2.
- 3. S. T. Koury, M. C. Bondurant and M. J. Koury, Localization of erythropoietin synthesizing cells in murine kidneys byhybridization,(1988) 524–527; DOI: 10.1038/ki.1993.115.
- 4. A. J. Erslev, Erythropoietin titers in health and disease,(Suppl 3) (1991) 2–8.
- 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,(1988) 620–623; DOI: 10.1172/JCI113363.
- 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,(2007) 1368–1380; DOI: 10.1016/j.clinthera.2007.07.014.
- 7. S. Sifakis, E. Angelakis, E. Vardaki, Y. Koumantaki, I. Matalliotakis and E. Koumantakis, Erythropoietin in the treatment of iron deficiency anemia during pregnancy,.(2001) 150–156; DOI: 10.1159/000052914.
- 8. P. Sabbatini, Strategies for optimizing hemoglobin response in cancer patients: focus on new epoetin alfa dosing regimens,(2004) 36–40; DOI: 10.1016/S1359–6349(03)00106-X
- 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,(1999) 2044–2047; DOI: 10.1086/315156.
- 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.(2003) 2074820 C.
- 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.(2004) 2528988 A1.
- 12. H. Woog, W. Gruber, H. J. Markl and F. Demmer, Stabilized erythropoietin preparations, U.S. Patent. 4992419, Feb 12, 1991; ref.(1994) 1330301 C.
- 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.(1989) 1258629 A1.
- 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.(1989) 1258628 A1.
- 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.(1991) 2074820 A1.
- 16. T. W. Strickland, Stable and preserved erythropoietin compositions, U.S. Patent 5,661,125, August 26, 1997.
- 17. T. Yamazaki, T. Morita and H. Nagai, Erythropoietin solution preparation, U.S. Patent 6,277,367, August 21, 2001.
- 18. M. M. Bradford, A rapid and sensitive method for the quantitation of microgram quantities of protein utilizing the principle of protein – dye binding,(1976) 248–254; DOI: 10.1016/0003-2697(76)90527-3.
- 19. T. Marshall, Sodium dodecyl sulfate polyacrylamide gel electrophoresis of serum after protein denaturation in the presence or absence of 2-mercaptoethanol,(1984) 475–479.
- 20, 5th ed., Strasbourg 2005, pp. 3494–3498.
- 21. J. O. Hess and C. Schumann, Erythropoietin liquid formulation, U. S. Patent 7,767,644, August 3, 2010; ref.(2012) 2558985 C.
- 22. T. W. Randolph and L. S. Jones, Surfactant-protein interactions,(2002) 159–175.
- 23. J. Chen and E. Dickinson, Protein/surfactant interfacial interactions Part 3. Competitive adsorption of protein + surfactant in emulsions,(1995) 77–85; DOI: 10.1016/0927-7757(95)03206-S.
- 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,(2003); DOI: 10.1208/ps050222.
- 25. E. Mori and B. Jirgensons, Effect of long-chain alkyl sulfate binding on circular dichroism and conformation of soybean trypsin inhibitor,(1981) 1630–1634; DOI: 10.1021/bi00509a034.
- 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.(2000) 2369444 A1.
- 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.(2004) 2528988 A1.
Language: English
Page range: 69 - 82
Accepted on: Sep 28, 2015
Published on: Mar 7, 2016
Published by: Croatian Pharmaceutical Society
In partnership with: Paradigm Publishing Services
Keywords:
Related subjects:
© 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.