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Mixing and transport during pharmaceutical twin-screw wet granulation: experimental analysis via chemical imaging.
Eur J Pharm Biopharm. 2014 Jul; 87(2):279-89.EJ

Abstract

Twin-screw granulation is a promising continuous alternative for traditional batch high shear wet granulation (HSWG). The extent of HSWG in a twin screw granulator (TSG) is greatly governed by the residence time of the granulation materials in the TSG and degree of mixing. In order to determine the residence time distribution (RTD) and mixing in TSG, mostly visual observation and particle tracking methods are used, which are either inaccurate and difficult for short RTD, or provide an RTD only for a finite number of preferential tracer paths. In this study, near infrared chemical imaging, which is more accurate and provides a complete RTD, was used. The impact of changes in material throughput (10-17 kg/h), screw speed (500-900 rpm), number of kneading discs (2-12) and stagger angle (30-90°) on the RTD and axial mixing of the material was characterised. The experimental RTD curves were used to calculate the mean residence time, mean centred variance and the Péclet number to determine the axial mixing and predominance of convective over dispersive transport. The results showed that screw speed is the most influential parameter in terms of RTD and axial mixing in the TSG and established a significant interaction between screw design parameters (number and stagger angle of kneading discs) and the process parameters (material throughput and number of kneading discs). The results of the study will allow the development and validation of a transport model capable of predicting the RTD and macro-mixing in the TSG. These can later be coupled with a population balance model in order to predict granulation yields in a TSG more accurately.

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Authors+Show Affiliations

Kumar A
BIOMATH, Dept. of Mathematical Modelling, Statistics and Bioinformatics, Ghent University, Gent, Belgium; Laboratory of Pharmaceutical Process Analytical Technology, Dept. of Pharmaceutical Analysis, Ghent University, Ghent, Belgium. Electronic address: ashish.kumar@ugent.be.
Vercruysse J
Laboratory of Pharmaceutical Technology, Dept. of Pharmaceutics, Ghent University, Ghent, Belgium. Electronic address: jurgen.vercruysse@ugent.be.
Toiviainen M
VTT Technical Research Centre of Finland, Optical Measurement Technologies, Kuopio, Finland. Electronic address: maunu.toiviainen@vtt.fi.
Panouillot PE
VTT Technical Research Centre of Finland, Optical Measurement Technologies, Kuopio, Finland. Electronic address: pierre-emmanuel.panouillot@vtt.fi.
Juuti M
VTT Technical Research Centre of Finland, Optical Measurement Technologies, Kuopio, Finland. Electronic address: mikko.juuti@vtt.fi.
Vanhoorne V
Laboratory of Pharmaceutical Technology, Dept. of Pharmaceutics, Ghent University, Ghent, Belgium. Electronic address: valerie.vanhoorne@ugent.be.
Vervaet C
Laboratory of Pharmaceutical Technology, Dept. of Pharmaceutics, Ghent University, Ghent, Belgium. Electronic address: chris.vervaet@ugent.be.
Remon JP
Laboratory of Pharmaceutical Technology, Dept. of Pharmaceutics, Ghent University, Ghent, Belgium. Electronic address: jeanpaul.remon@UGent.be.
Gernaey KV
CAPEC-PROCESS, Chemical and Biochemical Engineering, Technical University of Denmark, Kongens Lyngby, Denmark. Electronic address: kvg@kt.dtu.dk.
De Beer T
Laboratory of Pharmaceutical Process Analytical Technology, Dept. of Pharmaceutical Analysis, Ghent University, Ghent, Belgium. Electronic address: thomas.debeer@ugent.be.
Nopens I
BIOMATH, Dept. of Mathematical Modelling, Statistics and Bioinformatics, Ghent University, Gent, Belgium. Electronic address: ingmar.nopens@ugent.be.

MeSH

Chemistry, PharmaceuticalDosage FormsExcipientsLactoseRheologySpectroscopy, Near-InfraredTechnology, PharmaceuticalTheophyllineTime Factors

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24768925

Citation

Kumar, Ashish, et al. "Mixing and Transport During Pharmaceutical Twin-screw Wet Granulation: Experimental Analysis Via Chemical Imaging." European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, vol. 87, no. 2, 2014, pp. 279-89.
Kumar A, Vercruysse J, Toiviainen M, et al. Mixing and transport during pharmaceutical twin-screw wet granulation: experimental analysis via chemical imaging. Eur J Pharm Biopharm. 2014;87(2):279-89.
Kumar, A., Vercruysse, J., Toiviainen, M., Panouillot, P. E., Juuti, M., Vanhoorne, V., Vervaet, C., Remon, J. P., Gernaey, K. V., De Beer, T., & Nopens, I. (2014). Mixing and transport during pharmaceutical twin-screw wet granulation: experimental analysis via chemical imaging. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, 87(2), 279-89. https://doi.org/10.1016/j.ejpb.2014.04.004
Kumar A, et al. Mixing and Transport During Pharmaceutical Twin-screw Wet Granulation: Experimental Analysis Via Chemical Imaging. Eur J Pharm Biopharm. 2014;87(2):279-89. PubMed PMID: 24768925.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Mixing and transport during pharmaceutical twin-screw wet granulation: experimental analysis via chemical imaging. AU - Kumar,Ashish, AU - Vercruysse,Jurgen, AU - Toiviainen,Maunu, AU - Panouillot,Pierre-Emmanuel, AU - Juuti,Mikko, AU - Vanhoorne,Valérie, AU - Vervaet,Chris, AU - Remon,Jean Paul, AU - Gernaey,Krist V, AU - De Beer,Thomas, AU - Nopens,Ingmar, Y1 - 2014/04/23/ PY - 2014/02/01/received PY - 2014/04/05/revised PY - 2014/04/11/accepted PY - 2014/4/29/entrez PY - 2014/4/29/pubmed PY - 2015/2/3/medline KW - Axial mixing KW - Flow regime KW - NIR chemical imaging KW - Residence time distribution KW - Screw configuration KW - Twin-screw granulation SP - 279 EP - 89 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 87 IS - 2 N2 - Twin-screw granulation is a promising continuous alternative for traditional batch high shear wet granulation (HSWG). The extent of HSWG in a twin screw granulator (TSG) is greatly governed by the residence time of the granulation materials in the TSG and degree of mixing. In order to determine the residence time distribution (RTD) and mixing in TSG, mostly visual observation and particle tracking methods are used, which are either inaccurate and difficult for short RTD, or provide an RTD only for a finite number of preferential tracer paths. In this study, near infrared chemical imaging, which is more accurate and provides a complete RTD, was used. The impact of changes in material throughput (10-17 kg/h), screw speed (500-900 rpm), number of kneading discs (2-12) and stagger angle (30-90°) on the RTD and axial mixing of the material was characterised. The experimental RTD curves were used to calculate the mean residence time, mean centred variance and the Péclet number to determine the axial mixing and predominance of convective over dispersive transport. The results showed that screw speed is the most influential parameter in terms of RTD and axial mixing in the TSG and established a significant interaction between screw design parameters (number and stagger angle of kneading discs) and the process parameters (material throughput and number of kneading discs). The results of the study will allow the development and validation of a transport model capable of predicting the RTD and macro-mixing in the TSG. These can later be coupled with a population balance model in order to predict granulation yields in a TSG more accurately. SN - 1873-3441 UR - https://www.unboundmedicine.com/medline/citation/24768925/Mixing_and_transport_during_pharmaceutical_twin_screw_wet_granulation:_experimental_analysis_via_chemical_imaging_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0939-6411(14)00121-0 DB - PRIME DP - Unbound Medicine ER -