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

International Journal of Pharmaceutics
Margot FonteyneThomas De Beer

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.

References

Aug 31, 2010·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Barry CreanClive J Roberts
Oct 26, 2011·Pharmaceutical Development and Technology·Margot FonteyneThomas De Beer
Jun 13, 2012·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·J VercruysseC Vervaet
Aug 16, 2012·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Margot FonteyneThomas De Beer

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Citations

May 9, 2014·Journal of Pharmaceutical and Biomedical Analysis·P-Y SacréE Ziemons
Aug 2, 2015·International Journal of Pharmaceutics·H LiK P O'Donnell
Jan 7, 2015·International Journal of Pharmaceutics·J VercruysseC Vervaet
May 26, 2016·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·R MeierP Kleinebudde
Jul 28, 2016·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Tinne MonteyneThomas De Beer

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