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Theoretical and Experimental Evaluation of Flow Pattern of Pharmaceutical Powder Blends Discharged From Intermediate Bulk Containers (IBCs)
被引:9
|作者:
Nauka, Ewa
[1
]
Maurer, Reto
[2
]
Gonzalez, Amilcar A.
[1
]
Zhang, Wei
[1
]
Narang, Ajit S.
[1
]
Mao, Chen
[1
]
机构:
[1] Genentech Inc, Small Mol Pharmaceut Sci, San Francisco, CA 94080 USA
[2] F Hoffmann La Roche Ltd, Drug Prod Proc R&D, CH-4070 Basel, Switzerland
关键词:
Powder flow;
Flow pattern;
Powder stress;
Wall friction;
Hopper flow;
Intermediate bulk containers;
Pharmaceutical powder;
D O I:
10.1016/j.xphs.2020.10.007
中图分类号:
R914 [药物化学];
学科分类号:
100701 ;
摘要:
The purpose of this study is to assess the prevalence of funnel flow pattern for common pharmaceutical powder blends, upon discharging from modern intermediate bulk containers (IBCs) in drug product manufacturing. The estimation was built upon Jenike's original radial stress field theory. It was modified to account for the stress-dependence of wall friction angle commonly observed in pharmaceutical powders. A total of 260 flow pattern estimations, based on 20 real-life IBCs and 13 investigational powder blends, were made. The estimated results showed that the mass flow pattern is present in less than 5% of all cases. Funnel flow pattern is clearly prevalent among pharmaceutical powder blends. The prevalence of funnel flow stems from several factors: 1) relatively shallow hopper section shared by all IBCs, 2) the common transition-type geometry, leading to even shallower hopper inclination at the edge of the hopper section, and 3) relatively high wall friction angles resulting from low wall normal stresses. This conclusion was verified through at-scale experiments, by discharging multiple pharmaceutical powder blends from a representative IBC. In general, our study suggests that, unless the powder wall friction can be substantially reduced, pharmaceutical powders are likely to discharge under funnel flow from modern IBCs. (C) 2020 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.
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页码:1172 / 1181
页数:10
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