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Characterization of the Hydrodynamics in the USP Basket Apparatus Using Computational Fluid Dynamics.
J Pharm Sci. 2020 03; 109(3):1231-1241.JP

Abstract

Computational fluid dynamics (CFD) has been extensively used for the USP paddle apparatus II, but limited CFD studies have been conducted on the USP basket apparatus I. We expanded on past CFD basket studies to consider the presence of a tablet inside the basket, compared predictions to in vivo conditions, and confirmed observations around the complexity of nonuniform hydrodynamics. Tablets near the basket perimeter experienced near 5-fold increase in maximum velocity and surface shear stress compared to tablets placed at the center of the basket. At higher basket speeds, the predicted velocities at the center of the basket were closer to in vivo predictions but the surface shear stress was about 2 orders of magnitude lesser. Simulations with a high viscosity fluid (1 Pa-s) showed a 10-fold increase in shear stress on a tablet but a decrease in strain rate compared to low-viscosity medium (0.001 Pa-s) which could impact dissolution rates. Also presented are the insights into turbulent energy dissipation rates that could help in a priori prediction of dissolution rates. Overall, the CFD analysis presented in this work reveals significant differences between the basket and in vivo conditions and will help inform relevant in vitro testing.

Authors+Show Affiliations

Department of Chemical and Biological Engineering, Northwestern University, Evanston, Illinois 60208.Process Research and Development, AbbVie Inc., North Chicago, Illinois 60064.Process Research and Development, AbbVie Inc., North Chicago, Illinois 60064.NCE-Formulation Sciences, Drug Product Development, AbbVie Inc., North Chicago, Illinois 60064.NCE-Formulation Sciences, Drug Product Development, AbbVie Inc., North Chicago, Illinois 60064. Electronic address: steven.castleberry@abbvie.com.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31743682

Citation

Martinez, Andres F., et al. "Characterization of the Hydrodynamics in the USP Basket Apparatus Using Computational Fluid Dynamics." Journal of Pharmaceutical Sciences, vol. 109, no. 3, 2020, pp. 1231-1241.
Martinez AF, Sinha K, Nere N, et al. Characterization of the Hydrodynamics in the USP Basket Apparatus Using Computational Fluid Dynamics. J Pharm Sci. 2020;109(3):1231-1241.
Martinez, A. F., Sinha, K., Nere, N., Slade, R., & Castleberry, S. (2020). Characterization of the Hydrodynamics in the USP Basket Apparatus Using Computational Fluid Dynamics. Journal of Pharmaceutical Sciences, 109(3), 1231-1241. https://doi.org/10.1016/j.xphs.2019.11.008
Martinez AF, et al. Characterization of the Hydrodynamics in the USP Basket Apparatus Using Computational Fluid Dynamics. J Pharm Sci. 2020;109(3):1231-1241. PubMed PMID: 31743682.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Characterization of the Hydrodynamics in the USP Basket Apparatus Using Computational Fluid Dynamics. AU - Martinez,Andres F, AU - Sinha,Kushal, AU - Nere,Nandkishor, AU - Slade,Russell, AU - Castleberry,Steven, Y1 - 2019/11/16/ PY - 2019/07/18/received PY - 2019/10/14/revised PY - 2019/11/07/accepted PY - 2019/11/20/pubmed PY - 2021/6/22/medline PY - 2019/11/20/entrez KW - CFD KW - USP basket apparatus KW - dissolution KW - hydrodynamics KW - modeling SP - 1231 EP - 1241 JF - Journal of pharmaceutical sciences JO - J Pharm Sci VL - 109 IS - 3 N2 - Computational fluid dynamics (CFD) has been extensively used for the USP paddle apparatus II, but limited CFD studies have been conducted on the USP basket apparatus I. We expanded on past CFD basket studies to consider the presence of a tablet inside the basket, compared predictions to in vivo conditions, and confirmed observations around the complexity of nonuniform hydrodynamics. Tablets near the basket perimeter experienced near 5-fold increase in maximum velocity and surface shear stress compared to tablets placed at the center of the basket. At higher basket speeds, the predicted velocities at the center of the basket were closer to in vivo predictions but the surface shear stress was about 2 orders of magnitude lesser. Simulations with a high viscosity fluid (1 Pa-s) showed a 10-fold increase in shear stress on a tablet but a decrease in strain rate compared to low-viscosity medium (0.001 Pa-s) which could impact dissolution rates. Also presented are the insights into turbulent energy dissipation rates that could help in a priori prediction of dissolution rates. Overall, the CFD analysis presented in this work reveals significant differences between the basket and in vivo conditions and will help inform relevant in vitro testing. SN - 1520-6017 UR - https://www.unboundmedicine.com/medline/citation/31743682/Characterization_of_the_Hydrodynamics_in_the_USP_Basket_Apparatus_Using_Computational_Fluid_Dynamics_ DB - PRIME DP - Unbound Medicine ER -
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