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

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19 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 languageEnglish
JournalInternational Journal of Pharmaceutics
Volume462
Issue number1-2
Pages (from-to)8-10
Number of pages3
DOIs
Publication statusPublished - 28 Feb 2014

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