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Evaluation of torque as an in-process control for granule size during twin-screw wet granulation.
Ryckaert, A; Stauffer, F; Funke, A; Djuric, D; Vanhoorne, V; Vervaet, C; De Beer, T.
Afiliação
  • Ryckaert A; Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical analysis, Ghent University, Ottergemsesteenweg 460, 9000, Ghent, Belgium. Electronic address: AlexanderJ.Ryckaert@UGent.be.
  • Stauffer F; Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical analysis, Ghent University, Ottergemsesteenweg 460, 9000, Ghent, Belgium. Electronic address: Fanny.Stauffer@ucb.com.
  • Funke A; Chemical & Pharmaceutical Development, Pharma R&D, Bayer AG, Friedrich-Ebert-Straße 475, 42369, Wuppertal, Germany. Electronic address: Adrian.Funke@bayer.com.
  • Djuric D; Chemical & Pharmaceutical Development, Pharma R&D, Bayer AG, Friedrich-Ebert-Straße 475, 42369, Wuppertal, Germany. Electronic address: Dejan.Djuric@bayer.com.
  • Vanhoorne V; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics Ghent University, Ottergemsesteenweg 460, Ghent, Belgium. Electronic address: Valerie.Vanhoorne@UGent.be.
  • Vervaet C; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics Ghent University, Ottergemsesteenweg 460, Ghent, Belgium. Electronic address: Chris.Vervaet@UGent.be.
  • De Beer T; Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical analysis, Ghent University, Ottergemsesteenweg 460, 9000, Ghent, Belgium. Electronic address: Thomas.DeBeer@UGent.be.
Int J Pharm ; 602: 120642, 2021 Jun 01.
Article em En | MEDLINE | ID: mdl-33933640
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.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Tecnologia Farmacêutica / Temperatura Alta Idioma: En Revista: Int J Pharm Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Tecnologia Farmacêutica / Temperatura Alta Idioma: En Revista: Int J Pharm Ano de publicação: 2021 Tipo de documento: Article