TY - JOUR
T1 - Experimental and computational determination of the hydrodynamics of mini vessel dissolution testing systems
AU - Wang, Bing
AU - Armenante, Piero M.
N1 - Funding Information:
This work was partially supported through a grant from Merck & Co. , whose contribution is gratefully acknowledged. The authors would also like to thank Mr. Gerard Bredael of Merck & Co. for his stimulating comments and insights, and his overall contribution to this work.
Publisher Copyright:
© 2016 Elsevier B.V.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2016/8/20
Y1 - 2016/8/20
N2 - Mini vessel dissolution testing systems consist of a small-scale 100-mL vessel with a small paddle impeller, similar to the USP Apparatus 2, and are typically utilized when only small amounts of drug product are available during drug development. Despite their common industrial use, mini vessels have received little attention in the literature. Here, Computational Fluid Dynamics (CFD) was used to predict velocity profiles, flow patterns, and strain rate distribution in a mini vessel at different agitation speeds. These results were compared with experimental velocity measurements obtained with Particle Image Velocimetry (PIV). Substantial agreement was observed between CFD results and PIV data. The flow is strongly dominated by the tangential velocity component. Secondary flows consist of vertical upper and lower recirculation loops above and below the impeller. A low recirculation zone was observed in the lower part of the vessel. The radial and axial velocities in the region just below the impeller are very small especially in the innermost core zone below the paddle, where tablet dissolution occurs. Increasing agitation speed reduces the radius of this zone, which is always present at any speed, and only modestly increases the tangential flow intensity, with significant implication for dissolution testing in mini vessels.
AB - Mini vessel dissolution testing systems consist of a small-scale 100-mL vessel with a small paddle impeller, similar to the USP Apparatus 2, and are typically utilized when only small amounts of drug product are available during drug development. Despite their common industrial use, mini vessels have received little attention in the literature. Here, Computational Fluid Dynamics (CFD) was used to predict velocity profiles, flow patterns, and strain rate distribution in a mini vessel at different agitation speeds. These results were compared with experimental velocity measurements obtained with Particle Image Velocimetry (PIV). Substantial agreement was observed between CFD results and PIV data. The flow is strongly dominated by the tangential velocity component. Secondary flows consist of vertical upper and lower recirculation loops above and below the impeller. A low recirculation zone was observed in the lower part of the vessel. The radial and axial velocities in the region just below the impeller are very small especially in the innermost core zone below the paddle, where tablet dissolution occurs. Increasing agitation speed reduces the radius of this zone, which is always present at any speed, and only modestly increases the tangential flow intensity, with significant implication for dissolution testing in mini vessels.
KW - Agitation speed
KW - Computational Fluid Dynamics (CFD)
KW - Dissolution apparatus
KW - Dissolution testing
KW - Flow pattern
KW - Hydrodynamics
KW - Mini vessel
KW - Particle Image Velocimetry (PIV)
KW - Strain rate
KW - USP 2
KW - Velocity profiles
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U2 - 10.1016/j.ijpharm.2016.06.036
DO - 10.1016/j.ijpharm.2016.06.036
M3 - Article
C2 - 27317988
AN - SCOPUS:84978069217
SN - 0378-5173
VL - 510
SP - 336
EP - 349
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
IS - 1
ER -