A semi-theoretical model for simulating the temporal evolution of moisture-temperature during industrial fluidized bed granulation.

Evaporation rate Fluidized bed granulation Modeling Moisture Parameter estimation Process simulation

Journal

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V
ISSN: 1873-3441
Titre abrégé: Eur J Pharm Biopharm
Pays: Netherlands
ID NLM: 9109778

Informations de publication

Date de publication:
Jun 2020
Historique:
received: 17 01 2020
revised: 09 03 2020
accepted: 16 03 2020
pubmed: 19 4 2020
medline: 10 2 2021
entrez: 19 4 2020
Statut: ppublish

Résumé

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.

Identifiants

pubmed: 32304867
pii: S0939-6411(20)30077-1
doi: 10.1016/j.ejpb.2020.03.014
pii:
doi:

Substances chimiques

Excipients 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

137-152

Informations de copyright

Copyright © 2020 Elsevier B.V. All rights reserved.

Auteurs

Hossein Amini (H)

Otto H. York Department of Chemical and Materials Engineering, New Jersey Institute of Technology, Newark, NJ 07102, USA.

Xiaorong He (X)

Material & Analytical Sciences, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06810, USA.

Yin-Chao Tseng (YC)

Material & Analytical Sciences, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06810, USA.

Gulsad Kucuk (G)

Material & Analytical Sciences, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06810, USA.

Robert Schwabe (R)

Material & Analytical Sciences, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06810, USA.

Leon Schultz (L)

Material & Analytical Sciences, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06810, USA.

Martin Maus (M)

Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany.

Daniela Schröder (D)

Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany.

Pavol Rajniak (P)

Institute of Chemical and Environmental Engineering, Slovak University of Technology, Bratislava, Slovakia.

Ecevit Bilgili (E)

Otto H. York Department of Chemical and Materials Engineering, New Jersey Institute of Technology, Newark, NJ 07102, USA. Electronic address: bilgece@njit.edu.

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Classifications MeSH