Modelling the effect of L/S ratio and granule moisture content on the compaction properties in continuous manufacturing.

Autor: Monaco D; Department of Chemical and Biological Engineering, University of Sheffield, Sheffield S1 3JD, UK. Electronic address: dmonaco1@sheffield.ac.uk., Reynolds GK; Oral Product Development, Pharmaceutical Technology & Development, AstraZeneca, Macclesfield, UK., Tajarobi P; Early Product Development and Manufacture, Pharmaceutical Sciences, AstraZeneca, Gothenburg, Sweden., Litster JD; Department of Chemical and Biological Engineering, University of Sheffield, Sheffield S1 3JD, UK., Salman AD; Department of Chemical and Biological Engineering, University of Sheffield, Sheffield S1 3JD, UK.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics [Int J Pharm] 2023 Feb 25; Vol. 633, pp. 122624. Date of Electronic Publication: 2023 Jan 21.
DOI: 10.1016/j.ijpharm.2023.122624
Abstrakt: The pharmaceutical field is currently moving towards continuous manufacturing pursuing reduced waste, consistency, and automation. During continuous manufacturing, it is important to understand how both operating conditions and material properties throughout the process affect the final properties of the product to optimise and control production. In this study of a continuous wet granulation line, the liquid to solid ratio (L/S) and drying times were varied to investigate the effect of the final granule moisture content and the liquid to solid ratio on the properties of the granules during tabletting and the final tensile strength of the tablets. Both variables (L/S and granule moisture) affected the tablet tensile strength with the moisture content having a larger impact. Further analysis using a compaction model, showed that the compactability of the granules was largely unaffected by both L/S and moisture content while the compressibility was influenced by these variables, leading to a difference in the final tablet strength and porosity. The granule porosity was linked to the L/S ratio and used instead for the model fitting. The effect of moisture content and granule porosity was added to the model using a 3d plane relationship between the compressibility constant, the moisture content and porosity of the granules. The tablet tensile strength model, considering the effect of moisture and granule porosity, performed well averaging a root mean squared error across the different conditions of 0.17 MPa.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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