Experimental investigation of granule size and shape dynamics in twin-screw granulation

被引:28
|
作者
Kumar, Ashish [1 ,2 ]
Vercruysse, Jurgen [3 ]
Bellandi, Giacomo [1 ]
Gernaey, Krist V. [4 ]
Vervaet, Chris [3 ]
Remon, Jean Paul [3 ]
De Beer, Thomas [2 ]
Nopens, Ingmar [1 ]
机构
[1] Univ Ghent, Fac Biosci Engn, BIOMATH, Dept Math Modelling Stat & Bioinformat, B-9000 Ghent, Belgium
[2] Univ Ghent, Fac Pharmaceut Sci, Dept Pharmaceut Anal, Lab Pharmaceut Proc Analyt Technol, B-9000 Ghent, Belgium
[3] Univ Ghent, Fac Pharmaceut Sci, Dept Pharmaceut, Lab Pharmaceut Technol, B-9000 Ghent, Belgium
[4] Tech Univ Denmark, Dept Chem & Biochem Engn, CAPEC PROCESS, DK-2800 Lyngby, Denmark
关键词
Twin-screw granulation; Continuous pharmaceutical production; Granule size and shape analysis; WET GRANULATION;
D O I
10.1016/j.ijpharm.2014.09.020
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
A twin-screw granulator (TSG), a promising equipment for continuous high shear wet granulation (HSWG), achieves the desired level of mixing by a combination of the appropriate screw configuration and a suitable set of process settings (e.g. feed rate, screw speed, etc.), thus producing a certain granule size and shape distribution (GSSD). However, the primary sizing and shaping mechanism behind the resulting distribution is not well understood due to the opacity of the multiphase system in the granulator. This study experimentally characterised the GSSD dynamics along the TSG barrel length in order to understand the function of individual screw modules and process settings, as well as their interaction. Particle size analysis of granules collected at the outlet of the TSG suggested significant interaction between the process and screw configuration parameters influencing the heterogeneity in the GSSD. By characterising the samples collected along the screw length, a variable influence of the screw modules at different process conditions was observed. At low liquid-to-solid ratio (L/S), the first kneading module seemed to play a significant role in mixing, whereas the second kneading module was found to be more involved in reshaping the granules. At high L/S and high throughput, aggregation mainly took place in the second kneading module changing the GSSD. The results obtained from this study will be further used for the calibration and validation of a mechanistic model and, hence, support future development of a more detailed understanding of the HSWG process in a TSG. (C) 2014 Elsevier B.V. All rights reserved.
引用
收藏
页码:485 / 495
页数:11
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