Final published version
Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
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TY - JOUR
T1 - Prediction of product morphology of lyophilized drugs in the case of Vacuum Induced Surface Freezing
AU - Pisano, Roberto
AU - Capozzi, Luigi C.
PY - 2017/9/2
Y1 - 2017/9/2
N2 - In pharmaceutical industry, freeze-drying is often used to produce protein therapeutics that are stable during shipping and long-term storage. The design of adequate freezing process is a crucial aspect to be considered as influences the final morphology and, hence, physicochemical properties of the lyophilized product. In this study, a mechanistic model is developed for better understanding the relationship between morphology of lyophilized samples and freezing conditions. More specifically, we focus on Vacuum Induced Surface Freezing that is a recent, promising technology that allows a precise control of temperature of nucleation. Model simulations were validated by comparison with the lyophilized product morphology as observed by Scanning Electron Microscopy. The model was found to give accurate results for two liquid formulations, containing mannitol and sucrose, and varying nucleation temperature.
AB - In pharmaceutical industry, freeze-drying is often used to produce protein therapeutics that are stable during shipping and long-term storage. The design of adequate freezing process is a crucial aspect to be considered as influences the final morphology and, hence, physicochemical properties of the lyophilized product. In this study, a mechanistic model is developed for better understanding the relationship between morphology of lyophilized samples and freezing conditions. More specifically, we focus on Vacuum Induced Surface Freezing that is a recent, promising technology that allows a precise control of temperature of nucleation. Model simulations were validated by comparison with the lyophilized product morphology as observed by Scanning Electron Microscopy. The model was found to give accurate results for two liquid formulations, containing mannitol and sucrose, and varying nucleation temperature.
KW - Control
KW - Freeze-drying
KW - Freezing
KW - Modelling
KW - Pharmaceuticals
KW - Vacuum Induced Surface Freezing
U2 - 10.1016/j.cherd.2017.07.004
DO - 10.1016/j.cherd.2017.07.004
M3 - Journal article
AN - SCOPUS:85025157867
VL - 125
SP - 119
EP - 129
JO - Chemical Engineering Research and Design
JF - Chemical Engineering Research and Design
SN - 0263-8762
ER -