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Impact of screw configuration on the particle size distribution of granules produced by twin screw granulation.
Int J Pharm. 2015 Feb 01; 479(1):171-80.IJ

Abstract

Twin screw granulation (TSG) has been reported by different research groups as an attractive technology for continuous wet granulation. However, in contrast to fluidized bed granulation, granules produced via this technique typically have a wide and multimodal particle size distribution (PSD), resulting in suboptimal flow properties. The aim of the current study was to evaluate the impact of granulator screw configuration on the PSD of granules produced by TSG. Experiments were performed using a 25 mm co-rotating twin screw granulator, being part of the ConsiGma™-25 system (a fully continuous from-powder-to-tablet manufacturing line from GEA Pharma Systems). Besides the screw elements conventionally used for TSG (conveying and kneading elements), alternative designs of screw elements (tooth-mixing-elements (TME), screw mixing elements (SME) and cutters) were investigated using an α-lactose monohydrate formulation granulated with distilled water. Granulation with only conveying elements resulted in wide and multimodal PSD. Using kneading elements, the width of the PSD could be partially narrowed and the liquid distribution was more homogeneous. However, still a significant fraction of oversized agglomerates was obtained. Implementing additional kneading elements or cutters in the final section of the screw configuration was not beneficial. Furthermore, granulation with only TME or SME had limited impact on the width of the PSD. Promising results were obtained by combining kneading elements with SME, as for these configurations the PSD was narrower and shifted to the size fractions suitable for tableting.

Authors+Show Affiliations

Laboratory of Pharmaceutical Technology, Ghent University, Belgium.Department of Analytical Development, Johnson & Johnson Pharmaceutical Research and Development, Janssen Pharmaceutica, Belgium.Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Belgium.Global Technical Services, Janssen Supply Chain, Janssen Pharmaceutica, Belgium.Department of Pharmaceutical Development, Johnson & Johnson Pharmaceutical Research and Development, Janssen Pharmaceutica, Belgium.Department of Pharmaceutical Development, Johnson & Johnson Pharmaceutical Research and Development, Janssen Pharmaceutica, Belgium.Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Belgium.Laboratory of Pharmaceutical Technology, Ghent University, Belgium.Laboratory of Pharmaceutical Technology, Ghent University, Belgium. Electronic address: Chris.Vervaet@ugent.be.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

25562758

Citation

Vercruysse, J, et al. "Impact of Screw Configuration On the Particle Size Distribution of Granules Produced By Twin Screw Granulation." International Journal of Pharmaceutics, vol. 479, no. 1, 2015, pp. 171-80.
Vercruysse J, Burggraeve A, Fonteyne M, et al. Impact of screw configuration on the particle size distribution of granules produced by twin screw granulation. Int J Pharm. 2015;479(1):171-80.
Vercruysse, J., Burggraeve, A., Fonteyne, M., Cappuyns, P., Delaet, U., Van Assche, I., De Beer, T., Remon, J. P., & Vervaet, C. (2015). Impact of screw configuration on the particle size distribution of granules produced by twin screw granulation. International Journal of Pharmaceutics, 479(1), 171-80. https://doi.org/10.1016/j.ijpharm.2014.12.071
Vercruysse J, et al. Impact of Screw Configuration On the Particle Size Distribution of Granules Produced By Twin Screw Granulation. Int J Pharm. 2015 Feb 1;479(1):171-80. PubMed PMID: 25562758.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Impact of screw configuration on the particle size distribution of granules produced by twin screw granulation. AU - Vercruysse,J, AU - Burggraeve,A, AU - Fonteyne,M, AU - Cappuyns,P, AU - Delaet,U, AU - Van Assche,I, AU - De Beer,T, AU - Remon,J P, AU - Vervaet,C, Y1 - 2015/01/03/ PY - 2014/10/04/received PY - 2014/12/27/revised PY - 2014/12/31/accepted PY - 2015/1/7/entrez PY - 2015/1/7/pubmed PY - 2015/9/24/medline KW - Continuous processing KW - Particle size distribution KW - Process understanding KW - Screw configuration KW - Twin screw granulation SP - 171 EP - 80 JF - International journal of pharmaceutics JO - Int J Pharm VL - 479 IS - 1 N2 - Twin screw granulation (TSG) has been reported by different research groups as an attractive technology for continuous wet granulation. However, in contrast to fluidized bed granulation, granules produced via this technique typically have a wide and multimodal particle size distribution (PSD), resulting in suboptimal flow properties. The aim of the current study was to evaluate the impact of granulator screw configuration on the PSD of granules produced by TSG. Experiments were performed using a 25 mm co-rotating twin screw granulator, being part of the ConsiGma™-25 system (a fully continuous from-powder-to-tablet manufacturing line from GEA Pharma Systems). Besides the screw elements conventionally used for TSG (conveying and kneading elements), alternative designs of screw elements (tooth-mixing-elements (TME), screw mixing elements (SME) and cutters) were investigated using an α-lactose monohydrate formulation granulated with distilled water. Granulation with only conveying elements resulted in wide and multimodal PSD. Using kneading elements, the width of the PSD could be partially narrowed and the liquid distribution was more homogeneous. However, still a significant fraction of oversized agglomerates was obtained. Implementing additional kneading elements or cutters in the final section of the screw configuration was not beneficial. Furthermore, granulation with only TME or SME had limited impact on the width of the PSD. Promising results were obtained by combining kneading elements with SME, as for these configurations the PSD was narrower and shifted to the size fractions suitable for tableting. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/25562758/Impact_of_screw_configuration_on_the_particle_size_distribution_of_granules_produced_by_twin_screw_granulation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(15)00003-4 DB - PRIME DP - Unbound Medicine ER -