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PMID: 35578063 Published · ppublish English Journal Article

Impact of Select Geometric and Operational Parameters on Hydrodynamics in Dissolution Apparatus 2 (Paddle Apparatus): A Design of Experiments Analysis Based on Computational Fluid Dynamics Simulations.

Pharmaceutical research ·Vol. 39 ·No. 5 ·2022-05-00 ·页码 919-934

Perivilli S, Walfish S, Stippler E, Liddell MR

Abstract

A Design of Experiments (DOE) analysis driven by Computational Fluid Dynamics (CFD) simulations was used to evaluate individual and two-factor interaction effects of varying select geometric and operational parameters on the hydrodynamics in dissolution apparatus 2 (paddle apparatus). Simulations were run with meshing controls and solution strategies retained from a mesh-independent validated baseline model. Distance between vessel and impeller bottom surfaces, impeller offset, vessel radius and impeller rotation speed were considered as input parameters. The velocity magnitudes at four locations near the vessel bottom surface were considered as output parameters. Response surfaces and Pareto charts were generated to understand individual and two-factor interaction effects of input parameters on the output parameters. Impeller offset has a dominating influence of a linear and quadratic nature on the output parameters and affects overall hydrodynamics. Changes to other input parameters have limited influence on velocity magnitudes at locations closest to the vessel axis and on overall hydrodynamics. However, these parameters have important influences of varying degrees on velocity magnitudes at locations away from the vessel axis. The hydrodynamics in Apparatus 2 is influenced differently by different parameters and their combinations. Impeller offset has a stronger influence when compared to parameters that do not alter apparatus symmetry.

Keywords
design of experiments dissolution apparatus 2 hydrodynamics
MeSH 主题词
Computer Simulation Hydrodynamics Solubility
作者与单位
共 4 位作者,点击展开单位 / ORCID
Perivilli Satish
US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland, 20852-1790, USA. [email protected].
Walfish Steven
US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland, 20852-1790, USA.
Stippler Erika
European Directorate for the Quality of Medicines and Healthcare, 7 Allee Kastner, 67000, Strasbourg, France.
Liddell Mark R
US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland, 20852-1790, USA.
Article Info
Journal
Pharmaceutical research
Abbr.
Pharm Res
ISSN
1573-904X
Corresponding email
Published
2022-05-00
电子出版
2022-00-16
页码
919-934
Language
English
Country/Region
United States
NLM ID
8406521
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