Original scientific paper

https://doi.org/10.1515/acph-2016-0007

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

BAHGAT E. FAYED ; National research Center, Dokki, Cairo 12311, Egypt
ABDULKADER F. TAWFIK ; Department of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia
ALAA ELDEEN B. YASSIN orcid.org/0000-0003-3532-7583 ; Pharmaceutical Sciences Department, College of Pharmacy-3163 King Saud bin Abdulaziz University for Health Sciences, and King Abdullah International Medical Research Center, Ministry of National Guard, Health Affairs, Riyadh 11481, Saudi Arabia; Departmen

Abstract

The aim of this study was to optimize the formulation of erythropoietin (EPO) using amino acids instead of human serum albumin (HSA) and to evaluate its in vivo stability in order to avoid the risk of viral contamination and antigenicity. Different EPO formulas were developed in such a way was to allow studying the effects of amino acids and surfactants on the EPO stability profile. The main techniques applied for EPO analysis were ELISA, Bradford method, and SDS gel electrophoresis. The in vivo stability was evaluated in a Balb-c mouse animal model. The results showed that the presence of surfactant was very useful in preventing the initial adsorption of EPO on the walls of vials and in minimizing protein aggregation. Amino acid combinations, glycine with glutamic acid, provided maximum stability. Formulation F4 (containing glycine, glutamic acid and Tween 20) showed minimum aggregation and degradation and in vivo activity equivalent to commercially available HSA-stabilized EPO (Eprex®).

Keywords

erythropoietin (EPO); amino acids; human serum albumin; protein stability; Bradford; ELISA; gel electrophoresis

Hrčak ID:

146009

URI

https://hrcak.srce.hr/146009

Publication date:

31.3.2016.

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