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Visualization and understanding of the granulation liquid mixing and distribution during continuous twin screw granulation using NIR chemical imaging.
Eur J Pharm Biopharm. 2014 Apr; 86(3):383-92.EJ

Abstract

Over the last decade, there has been increased interest in the application of twin screw granulation as a continuous wet granulation technique for pharmaceutical drug formulations. However, the mixing of granulation liquid and powder material during the short residence time inside the screw chamber and the atypical particle size distribution (PSD) of granules produced by twin screw granulation is not yet fully understood. Therefore, this study aims at visualizing the granulation liquid mixing and distribution during continuous twin screw granulation using NIR chemical imaging. In first instance, the residence time of material inside the barrel was investigated as function of screw speed and moisture content followed by the visualization of the granulation liquid distribution as function of different formulation and process parameters (liquid feed rate, liquid addition method, screw configuration, moisture content and barrel filling degree). The link between moisture uniformity and granule size distributions was also studied. For residence time analysis, increased screw speed and lower moisture content resulted to a shorter mean residence time and narrower residence time distribution. Besides, the distribution of granulation liquid was more homogenous at higher moisture content and with more kneading zones on the granulator screws. After optimization of the screw configuration, a two-level full factorial experimental design was performed to evaluate the influence of moisture content, screw speed and powder feed rate on the mixing efficiency of the powder and liquid phase. From these results, it was concluded that only increasing the moisture content significantly improved the granulation liquid distribution. This study demonstrates that NIR chemical imaging is a fast and adequate measurement tool for allowing process visualization and hence for providing better process understanding of a continuous twin screw granulation system.

Authors+Show Affiliations

Department of Pharmaceutics, Ghent University, Belgium.Optical Measurement Technologies, VTT Technical Research Centre, Kuopio, Finland.Department of Pharmaceutical Analysis, Ghent University, Belgium.School of Pharmacy, University of Eastern Finland, Kuopio, Finland.School of Pharmacy, University of Eastern Finland, Kuopio, Finland.Optical Measurement Technologies, VTT Technical Research Centre, Kuopio, Finland.Department of Pharmaceutical Development, Johnson&Johnson Pharmaceutical Research and Development, Janssen Pharmaceutica, Belgium.Department of Pharmaceutical Development, Johnson&Johnson Pharmaceutical Research and Development, Janssen Pharmaceutica, Belgium.Department of Pharmaceutics, Ghent University, Belgium.Department of Pharmaceutics, Ghent University, Belgium.Department of Pharmaceutical Analysis, Ghent University, Belgium. Electronic address: Thomas.DeBeer@UGent.be.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

24211658

Citation

Vercruysse, Jurgen, et al. "Visualization and Understanding of the Granulation Liquid Mixing and Distribution During Continuous Twin Screw Granulation Using NIR Chemical Imaging." European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, vol. 86, no. 3, 2014, pp. 383-92.
Vercruysse J, Toiviainen M, Fonteyne M, et al. Visualization and understanding of the granulation liquid mixing and distribution during continuous twin screw granulation using NIR chemical imaging. Eur J Pharm Biopharm. 2014;86(3):383-92.
Vercruysse, J., Toiviainen, M., Fonteyne, M., Helkimo, N., Ketolainen, J., Juuti, M., Delaet, U., Van Assche, I., Remon, J. P., Vervaet, C., & De Beer, T. (2014). Visualization and understanding of the granulation liquid mixing and distribution during continuous twin screw granulation using NIR chemical imaging. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, 86(3), 383-92. https://doi.org/10.1016/j.ejpb.2013.10.012
Vercruysse J, et al. Visualization and Understanding of the Granulation Liquid Mixing and Distribution During Continuous Twin Screw Granulation Using NIR Chemical Imaging. Eur J Pharm Biopharm. 2014;86(3):383-92. PubMed PMID: 24211658.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Visualization and understanding of the granulation liquid mixing and distribution during continuous twin screw granulation using NIR chemical imaging. AU - Vercruysse,Jurgen, AU - Toiviainen,Maunu, AU - Fonteyne,Margot, AU - Helkimo,Niko, AU - Ketolainen,Jarkko, AU - Juuti,Mikko, AU - Delaet,Urbain, AU - Van Assche,Ivo, AU - Remon,Jean Paul, AU - Vervaet,Chris, AU - De Beer,Thomas, Y1 - 2013/11/06/ PY - 2013/07/25/received PY - 2013/10/15/revised PY - 2013/10/21/accepted PY - 2013/11/12/entrez PY - 2013/11/12/pubmed PY - 2014/12/17/medline KW - Granulation liquid distribution KW - NIR chemical imaging KW - Process understanding KW - Twin screw granulation SP - 383 EP - 92 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 86 IS - 3 N2 - Over the last decade, there has been increased interest in the application of twin screw granulation as a continuous wet granulation technique for pharmaceutical drug formulations. However, the mixing of granulation liquid and powder material during the short residence time inside the screw chamber and the atypical particle size distribution (PSD) of granules produced by twin screw granulation is not yet fully understood. Therefore, this study aims at visualizing the granulation liquid mixing and distribution during continuous twin screw granulation using NIR chemical imaging. In first instance, the residence time of material inside the barrel was investigated as function of screw speed and moisture content followed by the visualization of the granulation liquid distribution as function of different formulation and process parameters (liquid feed rate, liquid addition method, screw configuration, moisture content and barrel filling degree). The link between moisture uniformity and granule size distributions was also studied. For residence time analysis, increased screw speed and lower moisture content resulted to a shorter mean residence time and narrower residence time distribution. Besides, the distribution of granulation liquid was more homogenous at higher moisture content and with more kneading zones on the granulator screws. After optimization of the screw configuration, a two-level full factorial experimental design was performed to evaluate the influence of moisture content, screw speed and powder feed rate on the mixing efficiency of the powder and liquid phase. From these results, it was concluded that only increasing the moisture content significantly improved the granulation liquid distribution. This study demonstrates that NIR chemical imaging is a fast and adequate measurement tool for allowing process visualization and hence for providing better process understanding of a continuous twin screw granulation system. SN - 1873-3441 UR - https://www.unboundmedicine.com/medline/citation/24211658/Visualization_and_understanding_of_the_granulation_liquid_mixing_and_distribution_during_continuous_twin_screw_granulation_using_NIR_chemical_imaging_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0939-6411(13)00338-X DB - PRIME DP - Unbound Medicine ER -