Practical application of roller compaction process modeling

被引:91
作者
Reynolds, Gavin [2 ]
Ingale, Rohit [1 ]
Roberts, Ron [2 ]
Kothari, Sanjeev [1 ]
Gururajan, Bindhu [3 ]
机构
[1] AstraZeneca, Pharmaceut & Analyt Res & Dev, Wilmington, DE 19850 USA
[2] AstraZeneca, Pharmaceut & Analyt Res & Dev, Macclesfield SK10 2NA, Cheshire, England
[3] AstraZeneca, Pharmaceut & Analyt Res & Dev, Loughborough LE11 5RH, Leics, England
关键词
Roller compaction; Dry granulation; Pharmaceutical; Modeling; Ribbon density; Scale-up; GRANULAR SOLIDS; ROLLING THEORY; PRESS;
D O I
10.1016/j.compchemeng.2010.03.004
中图分类号
TP39 [计算机的应用];
学科分类号
080201 [机械制造及其自动化];
摘要
Very limited work has been reported on comparing the performance of the roller compaction process at different scales The majority of the approaches highlighted in the literature discuss the applicability of using confined uniaxial compaction for predicting the performance of the roller compaction process In this paper a method was developed that allows the rolling theory of granular solids developed by Johanson [Johanson, J R (1965) A rolling theory for granular solids. ASME, Journal of Applied Mechanics Series E, 32(4), 842-848] to be used to infer the underlying material parameters from small-scale roller compaction experiments for both separation controlled or screw controlled configurations Once these parameters are determined, the model can be used for predictive process design and scale-up in order to achieve target outputs such as ribbon density and throughput. The peak pressure, predicted by the model, can also be used to present roller compaction of a given formulation from a scale-independent perspective. This approach can be used to justify process parameter and equipment flexibility in the context of a pharmaceutical design space based on a proven acceptable range of peak pressures, or achieving target intermediate quality attributes, such as ribbon density. (C) 2010 Elsevier Ltd. All rights reserved
引用
收藏
页码:1049 / 1057
页数:9
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