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Evaluation of torque as an in-process control for granule size during twin-screw wet granulation.
Int J Pharm. 2021 Jun 01; 602:120642.IJ

Abstract

The potential of torque as in-process control (IPC) to monitor granule size in twin-screw wet granulation (TSG) was investigated. An experimental set-up allowing the collection of granules at four different locations (i.e., in the wetting zone, after the first and second kneading zone and at the end of the granulator) of the granulator screws was used to determine the change in granule size, granule temperature and the contribution of each compartment to the overall torque for varying screw speed, mass feed rate and liquid-to-solid ratio. The only observed correlation was between the granule size and torque increase after the first kneading zone because the torque increase was an indication of the degree in granule growth which was consistently observed with all applied granulation process parameters. No correlation was observed in the other locations as changes of torque were accompanied to either granule breakage and/or growth. Moreover, torque increase was correlated to higher granule temperature, suggesting that energy put into the granulator was partly used to heat up the material being processed and explains additionally the lack of correlation between granule size and torque. Therefore, this study showed that torque could not be used as IPC to monitor granule size during TSG.

Authors+Show Affiliations

Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical analysis, Ghent University, Ottergemsesteenweg 460, 9000, Ghent, Belgium. Electronic address: AlexanderJ.Ryckaert@UGent.be.Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical analysis, Ghent University, Ottergemsesteenweg 460, 9000, Ghent, Belgium. Electronic address: Fanny.Stauffer@ucb.com.Chemical & Pharmaceutical Development, Pharma R&D, Bayer AG, Friedrich-Ebert-Straβe 475, 42369, Wuppertal, Germany. Electronic address: Adrian.Funke@bayer.com.Chemical & Pharmaceutical Development, Pharma R&D, Bayer AG, Friedrich-Ebert-Straβe 475, 42369, Wuppertal, Germany. Electronic address: Dejan.Djuric@bayer.com.Laboratory of Pharmaceutical Technology, Department of Pharmaceutics Ghent University, Ottergemsesteenweg 460, Ghent, Belgium. Electronic address: Valerie.Vanhoorne@UGent.be.Laboratory of Pharmaceutical Technology, Department of Pharmaceutics Ghent University, Ottergemsesteenweg 460, Ghent, Belgium. Electronic address: Chris.Vervaet@UGent.be.Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical analysis, Ghent University, Ottergemsesteenweg 460, 9000, Ghent, Belgium. Electronic address: Thomas.DeBeer@UGent.be.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

33933640

Citation

Ryckaert, A, et al. "Evaluation of Torque as an In-process Control for Granule Size During Twin-screw Wet Granulation." International Journal of Pharmaceutics, vol. 602, 2021, p. 120642.
Ryckaert A, Stauffer F, Funke A, et al. Evaluation of torque as an in-process control for granule size during twin-screw wet granulation. Int J Pharm. 2021;602:120642.
Ryckaert, A., Stauffer, F., Funke, A., Djuric, D., Vanhoorne, V., Vervaet, C., & De Beer, T. (2021). Evaluation of torque as an in-process control for granule size during twin-screw wet granulation. International Journal of Pharmaceutics, 602, 120642. https://doi.org/10.1016/j.ijpharm.2021.120642
Ryckaert A, et al. Evaluation of Torque as an In-process Control for Granule Size During Twin-screw Wet Granulation. Int J Pharm. 2021 Jun 1;602:120642. PubMed PMID: 33933640.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of torque as an in-process control for granule size during twin-screw wet granulation. AU - Ryckaert,A, AU - Stauffer,F, AU - Funke,A, AU - Djuric,D, AU - Vanhoorne,V, AU - Vervaet,C, AU - De Beer,T, Y1 - 2021/04/29/ PY - 2021/03/17/received PY - 2021/04/20/revised PY - 2021/04/21/accepted PY - 2021/5/3/pubmed PY - 2021/5/3/medline PY - 2021/5/2/entrez KW - Continuous manufacturing KW - In-process control KW - Torque KW - Twin-screw granulation SP - 120642 EP - 120642 JF - International journal of pharmaceutics JO - Int J Pharm VL - 602 N2 - The potential of torque as in-process control (IPC) to monitor granule size in twin-screw wet granulation (TSG) was investigated. An experimental set-up allowing the collection of granules at four different locations (i.e., in the wetting zone, after the first and second kneading zone and at the end of the granulator) of the granulator screws was used to determine the change in granule size, granule temperature and the contribution of each compartment to the overall torque for varying screw speed, mass feed rate and liquid-to-solid ratio. The only observed correlation was between the granule size and torque increase after the first kneading zone because the torque increase was an indication of the degree in granule growth which was consistently observed with all applied granulation process parameters. No correlation was observed in the other locations as changes of torque were accompanied to either granule breakage and/or growth. Moreover, torque increase was correlated to higher granule temperature, suggesting that energy put into the granulator was partly used to heat up the material being processed and explains additionally the lack of correlation between granule size and torque. Therefore, this study showed that torque could not be used as IPC to monitor granule size during TSG. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/33933640/Evaluation_of_torque_as_an_in_process_control_for_granule_size_during_twin_screw_wet_granulation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(21)00447-6 DB - PRIME DP - Unbound Medicine ER -