Pharm Res (2018) 35: 131 https://doi.org/10.1007/s11095-018-2410-9 RESEARCH PAPER The Preservation of Lyophilized Human Growth Hormone Activity: how Do Buffers and Sugars Interact? 1 1 Andrea Arsiccio & Roberto Pisano Received: 12 February 2018 /Accepted: 16 April 2018 /Published online: 26 April 2018 # Springer Science+Business Media, LLC, part of Springer Nature 2018 ABSTRACT ABBREVIATIONS Purpose One of the most common classes of excipients used ATB Automated topology builder in protein formulations are buffers. The aim of this work is to COM Center of mass investigate the effect of buffers on protein stabilization given hGH Human growth hormone by sugars during freeze drying. mAbs Monoclonal antibodies Methods Molecular Dynamics simulations of human growth PDB Protein data bank hormone (hGH) in the presence of sucrose and trehalose were PME Particle mesh Ewald performed, and the impact of phosphate and citrate buffers on RMSD Root mean square deviation their protective action was analyzed. SPC/E Extended simple point charge model Results We found that buffers broke the hydrogen bonding network formed by excipients, and the consequences of this disruption of structure ordering were different in sucrose- based or trehalose-based formulations. More specifically, we INTRODUCTION observed that buffers increased protein recovery in the pres-
Pharmaceutical Research – Springer Journals
Published: Apr 26, 2018
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