A comparative pharmacokinetic and pharmacodynamic study of two novel Cuban PEGylated rHuEPO versus MIRCERA® and ior®EPOCIM

Autor: Gledys Reynaldo, Leyanis Rodríguez, Roberto Menéndez, Joaquín Solazábal, Daniel Amaro, María de los A. Becquer, Yamila Colom, Haydee Gil, Juan C. Polo, Gilberto Castañeda, Braulio Jiménez-Vélez, Jorge Duconge, Eduardo M. Fernández-Sánchez
Jazyk: English<br />Spanish; Castilian
Rok vydání: 2018
Předmět:
Zdroj: Journal of Pharmacy & Pharmacognosy Research, Vol 6, Iss 3, Pp 179-190 (2018)
Druh dokumentu: article
ISSN: 0719-4250
Popis: Context: The recombinant human erythropoietin (rHuEPO) stimulates the erythropoiesis process. Because this glycoprotein has a short half-life, it needs to be administrated two to three times a week. One of the technics to solve this issue is the PEGgilation. Aims: To evaluate the pharmacokinetics (PK) and pharmacodynamics of two new branched PEGylated erythropoietins (i.e., an asymmetric 32 kDa-PEG2-rHuEPO and a symmetric 40 kDa-PEG2-rHuEPO molecule) compared to non-PEGylated ior®EPOCIM and MIRCERA®. Methods: Serum concentrations of both PEGylated and non-PEGylated erythropoietins were measured at various time points in order to determine PK parameters using non-compartmental analysis approach. The reticulocyte (%), erythrocyte count and hemoglobin levels were ascertained in order to compare the effect of these molecules after administrating a single intravenous dose (10 μg/kg) of each product in male New Zealand rabbits. Results: Both branched PEGylated erythropoietin forms exhibited half-lives that were significantly longer than ior®EPOCIM (p
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