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关于双螺杆挤出过程停留时间分布作为固有混合指标的研究。

Investigations Concerning the Residence Time Distribution of Twin-Screw-Extrusion Processes as Indicator for Inherent Mixing.

作者信息

Wesholowski Jens, Berghaus Andreas, Thommes Markus

机构信息

Institute of Solids Process Engineering, TU Dortmund University, 44227 Dortmund, Germany.

COLVISTEC AG, 12489 Berlin, Germany.

出版信息

Pharmaceutics. 2018 Oct 26;10(4):207. doi: 10.3390/pharmaceutics10040207.

Abstract

Over recent years Twin-Screw-Extrusion (TSE) has been established as a platform technology for pharmaceutical manufacturing. Compared to other continuous operation, one of the major benefits of this method is the combination of several unit operations within one apparatus. Several of these are linked to the Residence Time Distribution (RTD), which is typically expressed by the residence time density function. One relevant aspect for pharmaceutical processes is the mixing capacity, which is represented by the width of this distribution. In the frame of this study the influence of the mass flow, the temperature and the screw-barrel clearance were investigated for a constant barrel load (specific feed load, SFL). While the total mass flow as well as the external screw diameter affected the mixing performance, the barrel temperature had no influence for the investigated range. The determined results were additionally evaluated with respect to a fit to the Twin-Dispersion-Model (TDM). This model is based on the superimposition of two mixing functions. The correlations between varied process parameters and the obtained characteristic model parameters proved this general physical view on extrusion.

摘要

近年来,双螺杆挤出(TSE)已成为药物制造的一种平台技术。与其他连续操作相比,该方法的主要优点之一是在一台设备内组合了多个单元操作。其中一些操作与停留时间分布(RTD)相关,停留时间分布通常由停留时间密度函数表示。药物工艺的一个相关方面是混合能力,它由该分布的宽度表示。在本研究框架内,针对恒定的料筒负荷(比进料负荷,SFL),研究了质量流量、温度和螺杆-料筒间隙的影响。虽然总质量流量以及外螺杆直径会影响混合性能,但在所研究的范围内,料筒温度没有影响。此外,根据与双分散模型(TDM)的拟合情况对确定的结果进行了评估。该模型基于两个混合函数的叠加。不同工艺参数与获得的特征模型参数之间的相关性证明了这种关于挤出的一般物理观点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e82/6320920/8388b249f62f/pharmaceutics-10-00207-g001.jpg

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