Studies on the metabolic fate of recombinant human erythropoietin (SNB-5001) I : Changes of plasma level measured by enzyme-immunoassay in rats and dogs after single intravenous and subcutaneous injection of SNB-5001
Time courses of plasma levels were examined using two-steps enzyme-immunoassay(EIA) in rats and dogs after single intravenous or subcutaneous injection of recombinant human erythropoietin (SNB-5001). After intravenous injection of SNB-5001 to rats and dogs, the plasma level declined biexponentially,...
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| Published in | Drug Metabolism and Pharmacokinetics Vol. 6; no. 5; pp. 683 - 692 |
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| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
The Japanese Society for the Study of Xenobiotics
1991
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0916-1139 |
| DOI | 10.2133/dmpk.6.683 |
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| Abstract | Time courses of plasma levels were examined using two-steps enzyme-immunoassay(EIA) in rats and dogs after single intravenous or subcutaneous injection of recombinant human erythropoietin (SNB-5001). After intravenous injection of SNB-5001 to rats and dogs, the plasma level declined biexponentially, well described by a two-compartment model. Plasma half lives of rapid phase and slower phase were 0.7 ?? 1hr(t1/2α) and 1.8 ?? 6hr(t1/2β) in rats, and 1 ?? /1.7hr (t1/2α) and 4.3 ?? 10.1hr (t1/2β) in dogs, respectively, after single intravenous injection in dosing range from 50 to 1250U/kg of SNB-5001. Plasma level profiles in female dogs were similar to those in male dogs after intravenous injection of SNB-5001. After the subcutanous injection of SNB-5001, plasma levels gradually increased showing a dose-dependent Cmax values. Tmax was 6 ?? 7hr in rats and 7 ?? 13hr in dogs. Plasma levels of SNB5001 determined by EIA showed a good correlation with the levels of biological activity determined by in vitro bioassay. Plasma SNB-5001 levels after subcutaneous injection declined slower than those after intravenous injection in rats and dogs. Plasma half lives in dogs were longer than those in rats after both intravenous and subcutaneous injection of SNB5001. The area under the plasma concentration-time curve increased in dose-dependent manner after intravenous and subcutaneous injection of SNB-5001 in rats and dogs. Bioavailabilities after subcutaneous injection were 50 ?? 60% in rats and 40 ?? 70% in dogs. |
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| AbstractList | Time courses of plasma levels were examined using two-steps enzyme-immunoassay(EIA) in rats and dogs after single intravenous or subcutaneous injection of recombinant human erythropoietin (SNB-5001). After intravenous injection of SNB-5001 to rats and dogs, the plasma level declined biexponentially, well described by a two-compartment model. Plasma half lives of rapid phase and slower phase were 0.7 ?? 1hr(t1/2α) and 1.8 ?? 6hr(t1/2β) in rats, and 1 ?? /1.7hr (t1/2α) and 4.3 ?? 10.1hr (t1/2β) in dogs, respectively, after single intravenous injection in dosing range from 50 to 1250U/kg of SNB-5001. Plasma level profiles in female dogs were similar to those in male dogs after intravenous injection of SNB-5001. After the subcutanous injection of SNB-5001, plasma levels gradually increased showing a dose-dependent Cmax values. Tmax was 6 ?? 7hr in rats and 7 ?? 13hr in dogs. Plasma levels of SNB5001 determined by EIA showed a good correlation with the levels of biological activity determined by in vitro bioassay. Plasma SNB-5001 levels after subcutaneous injection declined slower than those after intravenous injection in rats and dogs. Plasma half lives in dogs were longer than those in rats after both intravenous and subcutaneous injection of SNB5001. The area under the plasma concentration-time curve increased in dose-dependent manner after intravenous and subcutaneous injection of SNB-5001 in rats and dogs. Bioavailabilities after subcutaneous injection were 50 ?? 60% in rats and 40 ?? 70% in dogs. |
| Author | TSUDA, Eisuke UEDA, Masatsugu KOHSAKA, Kazuhiro MASUNAGA, Hiroaki TAKAHIRA, Reiko KOBAYASHI, Fumie |
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| References | 1) Graber, S.E. and Krantz, S.E. : Erythropoietin and the control of red cel 1 production. Annul. Rev. Med., 29 : 51-66 (1978). 7) Emmanouel, D. S., Goldwasser, E. and Katz A.I.: Metabolism of pure human erythropoietin in the rat. Am. J. Physiol., 247: 168-176 (1984). 3) Masunaga, H., Goto, M. and Ueda, M. : Effects of recombinant erythropoietin on in vivo hemopoiesis. ACTA HAEMATOL. JPN., 50 : 1119-1125 (1987). 5) Bommer, J., Ritz, E., Weinreich, T., Bommer, G. and Ziegler, T. : Subcutaneous erythropoietin. Lancet, ii : 406 (1988). 6) Weintraub, A. H., Gordon, A. S., Becker, E.L., Camiscoli, J. F. and Contrera, J. F. : Plasma and renal clearance of exogenous erythropoietin in the dog. Am. J. Physiol., 207 : 523-529 (1964). 10)マイコンによる薬物速度論入門，山岡清，谷川原祐介共著，南江堂:pp．113-178(1983 11) Cohen, R. A., Clemons. G. and Ebbe, S. : Correlation between bioassay and radioimmunoassay for erythropoietin in human serum and urine concentrates. Proc. Soc. Exp. Biol. Med., 179 : 296-299 (1985). 8) Goto, M., Murakami, A., Akai, K., Kawanishi, G., Ueda, M., Chiba, H. and Sasaki, R. : Characterization and use of monoclonal antibodies directed against human erythropoietin that recognized different antigenic determinants. Blood, 74 : 1415-1423 (1989). 4) Masunaga, H., Ueda, M., Sawai, T. and Kawanishi, G. : Effective admi nistration of erythropoietin for renal anemia. Jpn. J. Vet. Sci., 51 : 783-78 8 (1989). 12) Fu, J. S., Lertora. J.J. L., Brookins, J., Rice, J. C. and Fisher, J. W.: Pharmocokinetics of erythropoietin in intact and anephric dogs. J. Lab. Clin. Med., 111 : 669-676 (1988). 2) Goto, M., Akai, K., Murakami, A., Hashimoto, C., Tsuda, E., Ueda, M., Kawanishi, G., Takahashi, N., Ishimoto, A., Chiba,H. and Sasaki, R.: Production of recombinant human erythropoietin in mammalian cells: Host-cell dependency of the biological activity of the cloned glycoprotein. Biol Technology, 6 : 67-71 (1988). 9) Tsuda, E., Akai, K., Kawanishi, G., Ueda, M., Suda,T. and Miura, Y.: Microquantitative bioassay for erythropoietic activity by colorimetry. ACTA HAEMATOL. JPN., 53: 1045-1054 (1990). |
| References_xml | – reference: 6) Weintraub, A. H., Gordon, A. S., Becker, E.L., Camiscoli, J. F. and Contrera, J. F. : Plasma and renal clearance of exogenous erythropoietin in the dog. Am. J. Physiol., 207 : 523-529 (1964). – reference: 7) Emmanouel, D. S., Goldwasser, E. and Katz A.I.: Metabolism of pure human erythropoietin in the rat. Am. J. Physiol., 247: 168-176 (1984). – reference: 1) Graber, S.E. and Krantz, S.E. : Erythropoietin and the control of red cel 1 production. Annul. Rev. Med., 29 : 51-66 (1978). – reference: 8) Goto, M., Murakami, A., Akai, K., Kawanishi, G., Ueda, M., Chiba, H. and Sasaki, R. : Characterization and use of monoclonal antibodies directed against human erythropoietin that recognized different antigenic determinants. Blood, 74 : 1415-1423 (1989). – reference: 9) Tsuda, E., Akai, K., Kawanishi, G., Ueda, M., Suda,T. and Miura, Y.: Microquantitative bioassay for erythropoietic activity by colorimetry. ACTA HAEMATOL. JPN., 53: 1045-1054 (1990). – reference: 2) Goto, M., Akai, K., Murakami, A., Hashimoto, C., Tsuda, E., Ueda, M., Kawanishi, G., Takahashi, N., Ishimoto, A., Chiba,H. and Sasaki, R.: Production of recombinant human erythropoietin in mammalian cells: Host-cell dependency of the biological activity of the cloned glycoprotein. Biol Technology, 6 : 67-71 (1988). – reference: 5) Bommer, J., Ritz, E., Weinreich, T., Bommer, G. and Ziegler, T. : Subcutaneous erythropoietin. Lancet, ii : 406 (1988). – reference: 12) Fu, J. S., Lertora. J.J. L., Brookins, J., Rice, J. C. and Fisher, J. W.: Pharmocokinetics of erythropoietin in intact and anephric dogs. J. Lab. Clin. Med., 111 : 669-676 (1988). – reference: 4) Masunaga, H., Ueda, M., Sawai, T. and Kawanishi, G. : Effective admi nistration of erythropoietin for renal anemia. Jpn. J. Vet. Sci., 51 : 783-78 8 (1989). – reference: 10)マイコンによる薬物速度論入門，山岡清，谷川原祐介共著，南江堂:pp．113-178(1983)． – reference: 11) Cohen, R. A., Clemons. G. and Ebbe, S. : Correlation between bioassay and radioimmunoassay for erythropoietin in human serum and urine concentrates. Proc. Soc. Exp. Biol. Med., 179 : 296-299 (1985). – reference: 3) Masunaga, H., Goto, M. and Ueda, M. : Effects of recombinant erythropoietin on in vivo hemopoiesis. ACTA HAEMATOL. JPN., 50 : 1119-1125 (1987). |
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| Title | Studies on the metabolic fate of recombinant human erythropoietin (SNB-5001) I : Changes of plasma level measured by enzyme-immunoassay in rats and dogs after single intravenous and subcutaneous injection of SNB-5001 |
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