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Computational hydrodynamic comparison of a mini vessel and a USP 2 dissolution testing system to predict the dynamic operating conditions for similarity of dissolution performance.
Int J Pharm. 2018 Mar 25; 539(1-2):112-130.IJ

Abstract

The hydrodynamic characteristics of a mini vessel and a USP 2 dissolution testing system were obtained and compared to predict the tablet-liquid mass transfer coefficient from velocity distributions near the tablet and establish the dynamic operating conditions under which dissolution in mini vessels could be conducted to generate concentration profiles similar to those in the USP 2. Velocity profiles were obtained experimentally using Particle Image Velocimetry (PIV). Computational Fluid Dynamics (CFD) was used to predict the velocity distribution and strain rate around a model tablet. A CFD-based mass transfer model was also developed. When plotted against strain rate, the predicted tablet-liquid mass transfer coefficient was found to be independent of the system where it was obtained, implying that a tablet would dissolve at the same rate in both systems provided that the concentration gradient between the tablet surface and the bulk is the same, the tablet surface area per unit liquid volume is identical, and the two systems are operated at the appropriate agitation speeds specified in this work. The results of this work will help dissolution scientists operate mini vessels so as to predict the dissolution profiles in the USP 2, especially during the early stages of drug development.

Authors+Show Affiliations

Key Laboratory of Urban Pollutant Conversion, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China; New Jersey Institute of Technology, Otto H. York Department of Chemical, Biological and Pharmaceutical Engineering, Newark, NJ 07102-1982, USA.Merck & Co., Inc., Kenilworth, NJ 07033, USA.New Jersey Institute of Technology, Otto H. York Department of Chemical, Biological and Pharmaceutical Engineering, Newark, NJ 07102-1982, USA. Electronic address: piero.armenante@njit.edu.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29341921

Citation

Wang, Bing, et al. "Computational Hydrodynamic Comparison of a Mini Vessel and a USP 2 Dissolution Testing System to Predict the Dynamic Operating Conditions for Similarity of Dissolution Performance." International Journal of Pharmaceutics, vol. 539, no. 1-2, 2018, pp. 112-130.
Wang B, Bredael G, Armenante PM. Computational hydrodynamic comparison of a mini vessel and a USP 2 dissolution testing system to predict the dynamic operating conditions for similarity of dissolution performance. Int J Pharm. 2018;539(1-2):112-130.
Wang, B., Bredael, G., & Armenante, P. M. (2018). Computational hydrodynamic comparison of a mini vessel and a USP 2 dissolution testing system to predict the dynamic operating conditions for similarity of dissolution performance. International Journal of Pharmaceutics, 539(1-2), 112-130. https://doi.org/10.1016/j.ijpharm.2018.01.002
Wang B, Bredael G, Armenante PM. Computational Hydrodynamic Comparison of a Mini Vessel and a USP 2 Dissolution Testing System to Predict the Dynamic Operating Conditions for Similarity of Dissolution Performance. Int J Pharm. 2018 Mar 25;539(1-2):112-130. PubMed PMID: 29341921.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Computational hydrodynamic comparison of a mini vessel and a USP 2 dissolution testing system to predict the dynamic operating conditions for similarity of dissolution performance. AU - Wang,Bing, AU - Bredael,Gerard, AU - Armenante,Piero M, Y1 - 2018/01/16/ PY - 2017/08/01/received PY - 2017/12/29/revised PY - 2018/01/01/accepted PY - 2018/1/18/pubmed PY - 2018/9/18/medline PY - 2018/1/18/entrez KW - CFD KW - Hydrodynamics KW - Mass transfer KW - Mini vessel KW - PIV KW - Tablet KW - USP 2 dissolution testing apparatus SP - 112 EP - 130 JF - International journal of pharmaceutics JO - Int J Pharm VL - 539 IS - 1-2 N2 - The hydrodynamic characteristics of a mini vessel and a USP 2 dissolution testing system were obtained and compared to predict the tablet-liquid mass transfer coefficient from velocity distributions near the tablet and establish the dynamic operating conditions under which dissolution in mini vessels could be conducted to generate concentration profiles similar to those in the USP 2. Velocity profiles were obtained experimentally using Particle Image Velocimetry (PIV). Computational Fluid Dynamics (CFD) was used to predict the velocity distribution and strain rate around a model tablet. A CFD-based mass transfer model was also developed. When plotted against strain rate, the predicted tablet-liquid mass transfer coefficient was found to be independent of the system where it was obtained, implying that a tablet would dissolve at the same rate in both systems provided that the concentration gradient between the tablet surface and the bulk is the same, the tablet surface area per unit liquid volume is identical, and the two systems are operated at the appropriate agitation speeds specified in this work. The results of this work will help dissolution scientists operate mini vessels so as to predict the dissolution profiles in the USP 2, especially during the early stages of drug development. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/29341921/Computational_hydrodynamic_comparison_of_a_mini_vessel_and_a_USP_2_dissolution_testing_system_to_predict_the_dynamic_operating_conditions_for_similarity_of_dissolution_performance_ DB - PRIME DP - Unbound Medicine ER -