Distribution of binder in granules produced by means of twin screw granulation

Margot Fonteyne; Andrew Luke Fussell; Jurgen Vercruysse; Chris Vervaet; Jean Paul Remon; Clare Strachan; Thomas Rades; Thomas De Beer

doi:10.1016/j.ijpharm.2013.12.008

Distribution of binder in granules produced by means of twin screw granulation

Margot Fonteyne, Andrew Luke Fussell, Jurgen Vercruysse, Chris Vervaet, Jean Paul Remon, Clare Strachan, Thomas Rades, Thomas De Beer

17 Citations (Scopus)

Abstract

According to the quality by design principle processes may not remain black-boxes and full process understanding is required. The granule size distribution of granules produced via twin screw granulation is often found to be bimodal. The aim of this study was to gain a better understanding of binder distribution within granules produced via twin screw granulation in order to investigate if an inhomogeneous spread of binder is causing this bimodal size distribution. Theophylline-lactose-polyvinylpyrrolidone K30 (PVP) (30-67.5-2.5%, w/w) was used as a model formulation. The intra-granular distribution of PVP was evaluated by means of hyperspectral coherent anti-Stokes Raman scattering (CARS) microscopy. For the evaluated formulation, no PVP rich zones were detected when applying a lateral spatial resolution of 0.5 μm, indicating that PVP is homogenously distributed within the granules.

Original language	English
Journal	International Journal of Pharmaceutics
Volume	462
Issue number	1-2
Pages (from-to)	8-10
Number of pages	3
DOIs	https://doi.org/10.1016/j.ijpharm.2013.12.008
Publication status	Published - 28 Feb 2014

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title = "Distribution of binder in granules produced by means of twin screw granulation",

abstract = "According to the quality by design principle processes may not remain black-boxes and full process understanding is required. The granule size distribution of granules produced via twin screw granulation is often found to be bimodal. The aim of this study was to gain a better understanding of binder distribution within granules produced via twin screw granulation in order to investigate if an inhomogeneous spread of binder is causing this bimodal size distribution. Theophylline-lactose-polyvinylpyrrolidone K30 (PVP) (30-67.5-2.5%, w/w) was used as a model formulation. The intra-granular distribution of PVP was evaluated by means of hyperspectral coherent anti-Stokes Raman scattering (CARS) microscopy. For the evaluated formulation, no PVP rich zones were detected when applying a lateral spatial resolution of 0.5 μm, indicating that PVP is homogenously distributed within the granules.",

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T1 - Distribution of binder in granules produced by means of twin screw granulation

AU - Fonteyne, Margot

AU - Fussell, Andrew Luke

AU - Vercruysse, Jurgen

AU - Vervaet, Chris

AU - Remon, Jean Paul

AU - Strachan, Clare

AU - Rades, Thomas

AU - De Beer, Thomas

PY - 2014/2/28

Y1 - 2014/2/28

N2 - According to the quality by design principle processes may not remain black-boxes and full process understanding is required. The granule size distribution of granules produced via twin screw granulation is often found to be bimodal. The aim of this study was to gain a better understanding of binder distribution within granules produced via twin screw granulation in order to investigate if an inhomogeneous spread of binder is causing this bimodal size distribution. Theophylline-lactose-polyvinylpyrrolidone K30 (PVP) (30-67.5-2.5%, w/w) was used as a model formulation. The intra-granular distribution of PVP was evaluated by means of hyperspectral coherent anti-Stokes Raman scattering (CARS) microscopy. For the evaluated formulation, no PVP rich zones were detected when applying a lateral spatial resolution of 0.5 μm, indicating that PVP is homogenously distributed within the granules.

AB - According to the quality by design principle processes may not remain black-boxes and full process understanding is required. The granule size distribution of granules produced via twin screw granulation is often found to be bimodal. The aim of this study was to gain a better understanding of binder distribution within granules produced via twin screw granulation in order to investigate if an inhomogeneous spread of binder is causing this bimodal size distribution. Theophylline-lactose-polyvinylpyrrolidone K30 (PVP) (30-67.5-2.5%, w/w) was used as a model formulation. The intra-granular distribution of PVP was evaluated by means of hyperspectral coherent anti-Stokes Raman scattering (CARS) microscopy. For the evaluated formulation, no PVP rich zones were detected when applying a lateral spatial resolution of 0.5 μm, indicating that PVP is homogenously distributed within the granules.

U2 - 10.1016/j.ijpharm.2013.12.008

DO - 10.1016/j.ijpharm.2013.12.008

M3 - Journal article

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SN - 0378-5173

VL - 462

SP - 8

EP - 10

JO - International Journal of Pharmaceutics

JF - International Journal of Pharmaceutics

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ER -

Distribution of binder in granules produced by means of twin screw granulation

Abstract

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