Classification of the flow regimes in the flow-through cell

被引:30
作者
Kakhi, Maziar [1 ]
机构
[1] US FDA, Div Pharmaceut Anal, Silver Spring, MD 20993 USA
关键词
Dissolution; Flow-through cell; USP; 4; Laminar; Turbulent; Transitional; Pulsating flow; Open column; Packed column; COLLABORATIVE INVITRO DISSOLUTION; TRANSITION; METHODOLOGY; FLUID;
D O I
10.1016/j.ejps.2009.04.003
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
This paper examines the dissolution apparatus referred to as the flow-through cell from an engineering fluid mechanics viewpoint. The analysis demonstrates that laminar now predominantly occurs in the standard operation of this apparatus. It is argued that fully turbulent conditions are unlikely. Consequently. the phrases 'open column' and 'packed column' are suggested as technically more accurate terms for its operational characteristics than the conventionally referenced 'turbulent mode' and 'laminar mode'. Examples of flow profiles are given to show that the criterion of a "sinusoidal" input flow profile required by USP is not a sufficiently accurate characterization at the inlet as numerous profiles can be conceived which have the same average flow rate. The rationale of pulsating flows Versus constant, steady flows is discussed. Examples of how references to turbulence in the dissolution-related literature can lead to ambiguities and/or inconsistencies are highlighted. Published by Elsevier B.V.
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页码:531 / 544
页数:14
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