Understanding effect of filtration and washing on dried product: Paracetamol case study
Understanding effect of filtration and washing on dried product: Paracetamol case study
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DOI：
10.1016/j.powtec.2020.02.064
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发表时间：
2020-04-15
影响因子：
5.2
通讯作者：
Price, C. J.
中科院分区：
文献类型：
--
作者：
Ottoboni, S.;Simurda, M.;Price, C. J.
制药行业正在努力解决的一个关键挑战是在整个纯化和分离过程中保持颗粒的性质。本研究重点研究了在下游分离过程中浆料性质、洗脱剂、过滤和洗涤机制对原料药团聚/造粒的影响以及对产品物理性质的影响。在这项研究中，每个分离步骤都被分析，以确定有可能影响最终产品质量的因素，采用多变量统计设计的实验方法。结果发现，对增加颗粒团聚最不利的因素是输入材料的粒度、洗涤剂的数量和特性以及干燥模式。低沸点脂肪族碳氢化合物被证明是理想的最终洗涤溶剂，以减少结块的程度和强度，并产生自由流动的粉末/容易破坏的结块。(C)2020爱思唯尔B.V.保留所有权利。
One of the key challenges that the pharmaceutical industry is trying to address is to maintain particle properties across the entire purification and isolation process.This research focuses on the effect of slurry properties, wash solvent, filtration and washing mechanisms on API agglomeration/granulation during the processes of downstream isolation and the impact on the physical properties of the product. In this investigation, each isolation step was analysed to identify factors that have the potential to affect the final product qualities using a multivariate statistical design of experiments approach.The factors which were most detrimental in increasing particle agglomeration, were found to be the particle size of the input material, the quantity and identity of wash solvent and the drying mode. Low boiling point aliphatic hydrocarbons are shown to be desirable final wash solvents to reduce the extent and strength of agglomerates and to produce free flowing powder/readily disrupted agglomerates. (C) 2020 Elsevier B.V. All rights reserved.