Visualization and understanding of the granulation liquid mixing and distribution during continuous twin screw granulation using NIR chemical imaging

Jurgen Vercruysse, Maunu Toiviainen, Margot Fonteyne, Niko Helkimo, Jarkko Ketolainen, Mikko Juuti, Urbain Delaet, Ivo Van Assche, Jean Paul Remon, Chris Vervaet, Thomas De Beer (Corresponding Author)

Research output: Contribution to journalArticleScientificpeer-review

44 Citations (Scopus)

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.
Original languageEnglish
Pages (from-to)383-392
JournalEuropean Journal of Pharmaceutics and Biopharmaceutics
Volume86
Issue number3
DOIs
Publication statusPublished - 2014
MoE publication typeA1 Journal article-refereed

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Keywords

  • granulation liquid distribution
  • NIR chemical imaging
  • process understanding
  • twin screw granulation

Cite this

Vercruysse, Jurgen ; Toiviainen, Maunu ; Fonteyne, Margot ; Helkimo, Niko ; Ketolainen, Jarkko ; Juuti, Mikko ; Delaet, Urbain ; Van Assche, Ivo ; Remon, Jean Paul ; Vervaet, Chris ; De Beer, Thomas. / Visualization and understanding of the granulation liquid mixing and distribution during continuous twin screw granulation using NIR chemical imaging. In: European Journal of Pharmaceutics and Biopharmaceutics. 2014 ; Vol. 86, No. 3. pp. 383-392.
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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.",
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Vercruysse, J, Toiviainen, M, Fonteyne, M, Helkimo, N, Ketolainen, J, Juuti, M, Delaet, U, Van Assche, I, Remon, JP, 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, vol. 86, no. 3, pp. 383-392. https://doi.org/10.1016/j.ejpb.2013.10.012

Visualization and understanding of the granulation liquid mixing and distribution during continuous twin screw granulation using NIR chemical imaging. / Vercruysse, Jurgen; Toiviainen, Maunu; Fonteyne, Margot; Helkimo, Niko; Ketolainen, Jarkko; Juuti, Mikko; Delaet, Urbain; Van Assche, Ivo; Remon, Jean Paul; Vervaet, Chris; De Beer, Thomas (Corresponding Author).

In: European Journal of Pharmaceutics and Biopharmaceutics, Vol. 86, No. 3, 2014, p. 383-392.

Research output: Contribution to journalArticleScientificpeer-review

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

PY - 2014

Y1 - 2014

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.

AB - 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.

KW - granulation liquid distribution

KW - NIR chemical imaging

KW - process understanding

KW - twin screw granulation

U2 - 10.1016/j.ejpb.2013.10.012

DO - 10.1016/j.ejpb.2013.10.012

M3 - Article

VL - 86

SP - 383

EP - 392

JO - European Journal of Pharmaceutics and Biopharmaceutics

JF - European Journal of Pharmaceutics and Biopharmaceutics

SN - 0939-6411

IS - 3

ER -