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

Margot Fonteyne; A.L. 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, A.L. Fussell, Jurgen Vercruysse, Chris Vervaet, Jean Paul Remon, Clare Strachan, Thomas Rades, Thomas De Beer

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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
Pages (from-to)	8-10
Journal	International journal of pharmaceutics
Volume	462
Issue number	1-2
DOIs	https://doi.org/10.1016/j.ijpharm.2013.12.008
Publication status	Published - 2014

Keywords

METIS-311580
IR-97107

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10.1016/j.ijpharm.2013.12.008

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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",

keywords = "METIS-311580, IR-97107",

author = "Margot Fonteyne and A.L. Fussell and Jurgen Vercruysse and Chris Vervaet and Remon, {Jean Paul} and Clare Strachan and Thomas Rades and {De Beer}, Thomas",

year = "2014",

doi = "10.1016/j.ijpharm.2013.12.008",

language = "English",

volume = "462",

pages = "8--10",

journal = "International journal of pharmaceutics",

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TY - JOUR

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

AU - Fonteyne, Margot

AU - Fussell, A.L.

AU - Vercruysse, Jurgen

AU - Vervaet, Chris

AU - Remon, Jean Paul

AU - Strachan, Clare

AU - Rades, Thomas

AU - De Beer, Thomas

PY - 2014

Y1 - 2014

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

KW - METIS-311580

KW - IR-97107

U2 - 10.1016/j.ijpharm.2013.12.008

DO - 10.1016/j.ijpharm.2013.12.008

M3 - Article

SN - 0378-5173

VL - 462

SP - 8

EP - 10

JO - International journal of pharmaceutics

JF - International journal of pharmaceutics

IS - 1-2

ER -

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

Abstract

Keywords

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