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Research ArticleResearch

Stability Studies of a Freeze-Dried Recombinant Human Epidermal Growth Factor Formulation for Wound Healing

Héctor Santana, Gerardo García, Maribel Vega, Alejandro Beldarraín and Rolando Páez
PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 399-416; DOI: https://doi.org/10.5731/pdajpst.2015.01052
Héctor Santana
1Pharmaceutical Development Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba;
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  • For correspondence: hector.santana@cigb.edu.cu santanahector14@gmail.com
Gerardo García
2Quality Control Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba;
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Maribel Vega
2Quality Control Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba;
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Alejandro Beldarraín
3Central Office for Scientific Pole, Havana, Cuba
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Rolando Páez
1Pharmaceutical Development Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba;
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Abstract

We report on the stability assessment of a recombinant human epidermal growth factor (rhEGF) freeze-dried formulation for wound healing by intra-lesional injections. The suitability of packaging material for the light protection of finished dried powder was evaluated after stressed exposure conditions. Degradation kinetics of powder for injection was investigated at concentrations of 25–250 μg/vial and temperatures of 45, 60, and 70 °C. The long-term stability was evaluated after storage at 25 ± 2 °C/60 ± 5% relative humidity (6 months) and 2–8 °C (24 months) in the dark and analyzed at several time points. The stability after reconstitution with various diluents was also assessed after 24 h storage at 2–8 °C. The rhEGF samples were analyzed for structural integrity by reversed-phase high-performance liquid chromatography (RP-HPLC), size-exclusion HPLC, and sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE). Biological activity was investigated by measuring the cell proliferation in a murine fibroblast cell line. Results show that freeze-dried rhEGF in primary packaging only was photosensitive, as degradation by RP-HPLC that was completely suppressed by the secondary carton package was revealed. An increase in freeze-dried rhEGF stability was observed with the increase in protein concentration from 25 to 250 μg/vial. The long-term stability study showed no significant rhEGF degradation or physical change within the freeze-dried formulations containing 25 or 250 μg/vial of rhEGF. No physical, chemical or biological changes were observed for rhEGF after reconstitution in water for injection or 0.9% sodium chloride during the storage conditions studied.

LAY ABSTRACT: The stability of a recombinant human epidermal growth factor (rhEGF) freeze-dried formulation for wound healing by intra-lesional injections was assessed. The suitability of packaging material for the light protection of finished dried powder was evaluated after stressed exposure conditions. Degradation kinetics of powder for injection was investigated at concentrations of 25–250 μg/vial and temperatures of 45, 60, and 70 °C. The accelerated, long-term, and reconstitution stabilities were examined according to ICH guidelines for their utility time. The stability of rhEGF samples was analyzed by different chemical, physical, and biological activity assays. Results show that freeze-dried rhEGF in primary packaging only was photosensitive, as degradation by reversed-phase high performance liquid chromatography that was completely suppressed by the secondary carton package was revealed. An increase in freeze-dried rhEGF stability was observed with the increase in protein concentration. No significant rhEGF degradation or physical changes were observed within the freeze-dried formulations after 6 months storage at 25 ± 2 °C/60 ± 5% relative humidity or 24 months storage at 2–8 °C. No physical, chemical, or biological changes were observed for rhEGF after reconstitution in water for injection or 0.9% sodium chloride after 24 h storage at 2–8 °C.

  • Stability
  • Epidermal growth factor
  • Lyophilized formulation
  • Reconstitution
  • ICH
  • © PDA, Inc. 2015
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PDA Journal of Pharmaceutical Science and Technology: 69 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 3
May/June 2015
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Stability Studies of a Freeze-Dried Recombinant Human Epidermal Growth Factor Formulation for Wound Healing
Héctor Santana, Gerardo García, Maribel Vega, Alejandro Beldarraín, Rolando Páez
PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 399-416; DOI: 10.5731/pdajpst.2015.01052

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Stability Studies of a Freeze-Dried Recombinant Human Epidermal Growth Factor Formulation for Wound Healing
Héctor Santana, Gerardo García, Maribel Vega, Alejandro Beldarraín, Rolando Páez
PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 399-416; DOI: 10.5731/pdajpst.2015.01052
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Keywords

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  • Lyophilized formulation
  • reconstitution
  • ICH

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