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

Autor: Wang LG; Department of Chemical and Biological Engineering, University of Sheffield, UK; Siemens Process Systems Engineering, Hammersmith, London, UK., Omar C; Department of Chemical and Biological Engineering, University of Sheffield, UK., Litster JD; Department of Chemical and Biological Engineering, University of Sheffield, UK. Electronic address: James.Litster@sheffield.ac.uk., Li J; Siemens Process Systems Engineering, Parsippany, NJ Office, USA., Mitchell N; Siemens Process Systems Engineering, Hammersmith, London, UK., Bellinghausen S; Siemens Process Systems Engineering, Hammersmith, London, UK., Barrasso D; Siemens Process Systems Engineering, Parsippany, NJ Office, USA., Salman A; Department of Chemical and Biological Engineering, University of Sheffield, UK., Slade D; Siemens Process Systems Engineering, Hammersmith, London, UK.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics [Int J Pharm] 2021 Sep 25; Vol. 607, pp. 120934. Date of Electronic Publication: 2021 Jul 24.
DOI: 10.1016/j.ijpharm.2021.120934
Abstrakt: 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.
(Copyright © 2021 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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