TY - JOUR
T1 - A semi-theoretical model for simulating the temporal evolution of moisture-temperature during industrial fluidized bed granulation
AU - Amini, Hossein
AU - He, Xiaorong
AU - Tseng, Yin Chao
AU - Kucuk, Gulsad
AU - Schwabe, Robert
AU - Schultz, Leon
AU - Maus, Martin
AU - Schröder, Daniela
AU - Rajniak, Pavol
AU - Bilgili, Ecevit
N1 - Funding Information:
The first author (H.A.) and the corresponding author (E.B.) acknowledge the financial support by Boehringer Ingelheim Pharmaceuticals, Inc. for the project titled “Computational Modeling of Pharmaceutical Fluidized Bed Granulation for Enhanced Process-Product Understanding” through the Research Agreement #210755 .
Publisher Copyright:
© 2020 Elsevier B.V.
PY - 2020/6
Y1 - 2020/6
N2 - Moisture plays a major role in determining the attributes of granules prepared by fluidized bed granulation (FBG). Here, a semi-theoretical droplet-based evaporation rate model was developed and incorporated into moisture mass-enthalpy balances to simulate the temporal evolution of bed moisture-temperature. Experimental data from a GPCG30 unit were used to fit the model parameters. With only two fitting parameters, the model demonstrated excellent capability to describe the moisture-temperature evolution for a wide range of operating conditions. Then, in a global process model (GPM) approach, the evaporation parameters were fitted to multi-linear functions of inlet air temperature, binder concentration, and spray rate. The GPM was validated successfully by simulating a different data set which was not used in its calibration. As the GPM demonstrated a good predictive capability, it was further used to investigate the impacts of process parameters. Numerical simulations suggest that the proposed GPM predicts the experimentally well-established trends of moisture-temperature profiles in previously published data, proving the applicability of the GPM approach. This study has demonstrated the capabilities of simple process models as a practical approach to predict time-wise evolution of bed moisture-temperature profiles in industrial FBG modeling, while also pointing out their limitations.
AB - Moisture plays a major role in determining the attributes of granules prepared by fluidized bed granulation (FBG). Here, a semi-theoretical droplet-based evaporation rate model was developed and incorporated into moisture mass-enthalpy balances to simulate the temporal evolution of bed moisture-temperature. Experimental data from a GPCG30 unit were used to fit the model parameters. With only two fitting parameters, the model demonstrated excellent capability to describe the moisture-temperature evolution for a wide range of operating conditions. Then, in a global process model (GPM) approach, the evaporation parameters were fitted to multi-linear functions of inlet air temperature, binder concentration, and spray rate. The GPM was validated successfully by simulating a different data set which was not used in its calibration. As the GPM demonstrated a good predictive capability, it was further used to investigate the impacts of process parameters. Numerical simulations suggest that the proposed GPM predicts the experimentally well-established trends of moisture-temperature profiles in previously published data, proving the applicability of the GPM approach. This study has demonstrated the capabilities of simple process models as a practical approach to predict time-wise evolution of bed moisture-temperature profiles in industrial FBG modeling, while also pointing out their limitations.
KW - Evaporation rate
KW - Fluidized bed granulation
KW - Modeling
KW - Moisture
KW - Parameter estimation
KW - Process simulation
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U2 - 10.1016/j.ejpb.2020.03.014
DO - 10.1016/j.ejpb.2020.03.014
M3 - Article
C2 - 32304867
AN - SCOPUS:85083493400
SN - 0939-6411
VL - 151
SP - 137
EP - 152
JO - European Journal of Pharmaceutics and Biopharmaceutics
JF - European Journal of Pharmaceutics and Biopharmaceutics
ER -