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Distribution of binder in granules produced by means of twin screw granulation.
Int J Pharm. 2014 Feb 28; 462(1-2):8-10.IJ

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.

Authors+Show Affiliations

Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Ghent, Belgium. Electronic address: Margot.Fonteyne@Ugent.be.Optical Sciences group, MESA+ Institute for Nanotechnology, University of Twente, Enschede, The Netherlands.Laboratory of Pharmaceutical Technology, Ghent University, Ghent, Belgium.Laboratory of Pharmaceutical Technology, Ghent University, Ghent, Belgium.Laboratory of Pharmaceutical Technology, Ghent University, Ghent, Belgium.Faculty of Pharmacy, Division of Pharmaceutical Technology, University of Helsinki, Finland.School of Pharmacy, Otago University, Dunedin, New Zealand; Department of Pharmacy, Copenhagen University, Copenhagen, Denmark.Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Ghent, Belgium.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

24361911

Citation

Fonteyne, Margot, et al. "Distribution of Binder in Granules Produced By Means of Twin Screw Granulation." International Journal of Pharmaceutics, vol. 462, no. 1-2, 2014, pp. 8-10.
Fonteyne M, Fussell AL, Vercruysse J, et al. Distribution of binder in granules produced by means of twin screw granulation. Int J Pharm. 2014;462(1-2):8-10.
Fonteyne, M., Fussell, A. L., Vercruysse, J., Vervaet, C., Remon, J. P., Strachan, C., Rades, T., & De Beer, T. (2014). Distribution of binder in granules produced by means of twin screw granulation. International Journal of Pharmaceutics, 462(1-2), 8-10. https://doi.org/10.1016/j.ijpharm.2013.12.008
Fonteyne M, et al. Distribution of Binder in Granules Produced By Means of Twin Screw Granulation. Int J Pharm. 2014 Feb 28;462(1-2):8-10. PubMed PMID: 24361911.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR 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, Y1 - 2013/12/19/ PY - 2013/10/11/received PY - 2013/12/05/revised PY - 2013/12/09/accepted PY - 2013/12/24/entrez PY - 2013/12/24/pubmed PY - 2014/9/23/medline KW - Binder distribution KW - CARS KW - Twin screw granulation SP - 8 EP - 10 JF - International journal of pharmaceutics JO - Int J Pharm VL - 462 IS - 1-2 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. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/24361911/Distribution_of_binder_in_granules_produced_by_means_of_twin_screw_granulation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(13)01076-4 DB - PRIME DP - Unbound Medicine ER -