Optimization of amino acid-stabilized erythropoietin parenteral formulation: In vitro and in vivo assessment
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 formulations were developed in such a way as to...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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Sciendo
2016-03-01
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| Series: | Acta Pharmaceutica |
| Subjects: | |
| Online Access: | https://doi.org/10.1515/acph-2016-0007 |
| _version_ | 1818690171316469760 |
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| author | Fayed Bahgat E. Tawfik Abdulkader F. Yassin Alaa Eldeen B. |
| author_facet | Fayed Bahgat E. Tawfik Abdulkader F. Yassin Alaa Eldeen B. |
| author_sort | Fayed Bahgat E. |
| collection | DOAJ |
| description | 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 formulations were developed in such a way as 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®). |
| first_indexed | 2024-12-17T12:21:45Z |
| format | Article |
| id | doaj.art-691fe924b52d45ac8899b102b034d167 |
| institution | Directory Open Access Journal |
| issn | 1846-9558 |
| language | English |
| last_indexed | 2024-12-17T12:21:45Z |
| publishDate | 2016-03-01 |
| publisher | Sciendo |
| record_format | Article |
| series | Acta Pharmaceutica |
| spelling | doaj.art-691fe924b52d45ac8899b102b034d1672022-12-21T21:48:56ZengSciendoActa Pharmaceutica1846-95582016-03-01661698210.1515/acph-2016-0007acph-2016-0007Optimization of amino acid-stabilized erythropoietin parenteral formulation: In vitro and in vivo assessmentFayed Bahgat E.0Tawfik Abdulkader F.1Yassin Alaa Eldeen B.2 National Research Center, Dokki, Cairo 12311, Egypt Department of Pharmaceutics College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia 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 ArabiaThe 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 formulations were developed in such a way as 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®).https://doi.org/10.1515/acph-2016-0007erythropoietin (epo)amino acidshuman serum albuminprotein stabilitybradfordelisagel electrophoresis |
| spellingShingle | Fayed Bahgat E. Tawfik Abdulkader F. Yassin Alaa Eldeen B. Optimization of amino acid-stabilized erythropoietin parenteral formulation: In vitro and in vivo assessment Acta Pharmaceutica erythropoietin (epo) amino acids human serum albumin protein stability bradford elisa gel electrophoresis |
| title | Optimization of amino acid-stabilized erythropoietin parenteral formulation: In vitro and in vivo assessment |
| title_full | Optimization of amino acid-stabilized erythropoietin parenteral formulation: In vitro and in vivo assessment |
| title_fullStr | Optimization of amino acid-stabilized erythropoietin parenteral formulation: In vitro and in vivo assessment |
| title_full_unstemmed | Optimization of amino acid-stabilized erythropoietin parenteral formulation: In vitro and in vivo assessment |
| title_short | Optimization of amino acid-stabilized erythropoietin parenteral formulation: In vitro and in vivo assessment |
| title_sort | optimization of amino acid stabilized erythropoietin parenteral formulation in vitro and in vivo assessment |
| topic | erythropoietin (epo) amino acids human serum albumin protein stability bradford elisa gel electrophoresis |
| url | https://doi.org/10.1515/acph-2016-0007 |
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