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Velocity distribution and shear rate variability resulting from changes in the impeller location in the USP dissolution testing apparatus II.
Pharm Res. 2008 Feb; 25(2):320-36.PR

Abstract

PURPOSE

The United States Pharmacopoeia (USP) imposes strict requirements on the geometry and operating conditions of the USP Dissolution Testing Apparatus II. A previously validated Computational Fluid Dynamics (CFD) approach was used here to study the hydrodynamics of USP Apparatus II when the impeller was placed at four different locations, all within the limits specified by USP.

METHOD

CFD was used to predict the velocity profiles, energy dissipation rates, and strain rates when the impeller was placed in the reference location (centrally mounted, 25 mm off the vessel bottom), 2 mm off-center, 2 mm higher, and 2 mm lower than the reference location.

RESULTS

Small changes in impeller location, especially if associated with loss of symmetry, produced extensive changes in velocity profiles and shear rates. Centrally located impellers, irrespective of their off-bottom clearance, produced non-uniform but nearly symmetric strain rates. The off-center impeller produced a more uniform but slightly asymmetric strain rate distribution.

CONCLUSIONS

The system hydrodynamics depends strongly on small differences in equipment configurations and operating conditions, which are likely to affect significantly the flow field and shear rate experienced by the oral dosage form being tested, and hence the solid-liquid mass transfer and dissolution rate.

Authors+Show Affiliations

Otto H. York Department of Chemical Engineering, New Jersey Institute of Technology, 323 ML King Boulevard, Newark, New Jersey 07102-1982, USA.No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

18040760

Citation

Bai, Ge, and Piero M. Armenante. "Velocity Distribution and Shear Rate Variability Resulting From Changes in the Impeller Location in the USP Dissolution Testing Apparatus II." Pharmaceutical Research, vol. 25, no. 2, 2008, pp. 320-36.
Bai G, Armenante PM. Velocity distribution and shear rate variability resulting from changes in the impeller location in the USP dissolution testing apparatus II. Pharm Res. 2008;25(2):320-36.
Bai, G., & Armenante, P. M. (2008). Velocity distribution and shear rate variability resulting from changes in the impeller location in the USP dissolution testing apparatus II. Pharmaceutical Research, 25(2), 320-36.
Bai G, Armenante PM. Velocity Distribution and Shear Rate Variability Resulting From Changes in the Impeller Location in the USP Dissolution Testing Apparatus II. Pharm Res. 2008;25(2):320-36. PubMed PMID: 18040760.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Velocity distribution and shear rate variability resulting from changes in the impeller location in the USP dissolution testing apparatus II. AU - Bai,Ge, AU - Armenante,Piero M, Y1 - 2007/11/27/ PY - 2007/07/02/received PY - 2007/10/11/accepted PY - 2007/11/28/pubmed PY - 2008/4/23/medline PY - 2007/11/28/entrez SP - 320 EP - 36 JF - Pharmaceutical research JO - Pharm Res VL - 25 IS - 2 N2 - PURPOSE: The United States Pharmacopoeia (USP) imposes strict requirements on the geometry and operating conditions of the USP Dissolution Testing Apparatus II. A previously validated Computational Fluid Dynamics (CFD) approach was used here to study the hydrodynamics of USP Apparatus II when the impeller was placed at four different locations, all within the limits specified by USP. METHOD: CFD was used to predict the velocity profiles, energy dissipation rates, and strain rates when the impeller was placed in the reference location (centrally mounted, 25 mm off the vessel bottom), 2 mm off-center, 2 mm higher, and 2 mm lower than the reference location. RESULTS: Small changes in impeller location, especially if associated with loss of symmetry, produced extensive changes in velocity profiles and shear rates. Centrally located impellers, irrespective of their off-bottom clearance, produced non-uniform but nearly symmetric strain rates. The off-center impeller produced a more uniform but slightly asymmetric strain rate distribution. CONCLUSIONS: The system hydrodynamics depends strongly on small differences in equipment configurations and operating conditions, which are likely to affect significantly the flow field and shear rate experienced by the oral dosage form being tested, and hence the solid-liquid mass transfer and dissolution rate. SN - 0724-8741 UR - https://www.unboundmedicine.com/medline/citation/18040760/Velocity_distribution_and_shear_rate_variability_resulting_from_changes_in_the_impeller_location_in_the_USP_dissolution_testing_apparatus_II_ DB - PRIME DP - Unbound Medicine ER -