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Tableting model assessment of porosity and tensile strength using a continuous wet granulation route

By Wang, Li Ge; Omar, Chalak; Li, Jianfeng; Mitchell, Niall; Bellinghausen, Stefan; Barrasso, Dana; Salman, Agba; Slade, David

Published on

Abstract

This paper presents a comprehensive assessment of the most widely used tablet compaction models in a continuous wet granulation tableting process. The porosity models, tensile strength models and lubricant models are reviewed from the literature and classified based on their formulations i.e. empirical or theoretical and applications, i.e. batch or continuous. The majority of these models are empirical and were initially developed for batch tabletting process. To ascertain their effectiveness and serviceability in the continuous tableting process, a continuous powder processing line of Diamond Pilot Plant (DiPP) installed at The University of Sheffield was used to provide the quantitative data for tablet model assessment. Magnesium stearate (MgSt) is used as a lubricant to investigate its influence on the tensile strength. Whilst satisfactory predictions from the tablet models can be produced, a compromise between the model fidelity and model simplicity needs to be made for a suitable model selection. The Sonnergaard model outperforms amongst the porosity models whilst the Reynolds model produces the best goodness of fitting for two parameters fitting porosity models. An improved tensile strength model is proposed to consider the influence of powder size and porosity in the continuous tableting process.

Journal

International Journal of Pharmaceutics. Volume 607, 2021, 120934

DOI

10.1016/j.ijpharm.2021.120934

Type of publication

Peer-reviewed journal

Affiliations

  • University of Sheffield

Article Classification

Research article

Classification Areas

  • Oral solid dose
  • Process Control

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