Simulating the hydrodynamic conditions in the united states pharmacopeia paddle dissolution apparatus
- 1 June 2003
- journal article
- Published by Springer Science and Business Media LLC in AAPS PharmSciTech
- Vol. 4 (2), 83-98
- https://doi.org/10.1208/pt040222
Abstract
The objective of this work was to examine the feasibility of developing a high-performance computing software system to simulate the United States Pharmacopeia (USP) dissolution apparatus 2 (paddle apparatus) and thus aid in characterizing the fluid hydrodynamics in the method. The USP apparatus was modeled using the hydrodynamic package Fluent. The Gambit program was used to create a "wireframe" of the apparatus and generate the 3-dimensional grids for the computational fluid dynamics solver. The Fluent solver was run on an IBM RS/6000 SP distributed memory parallel processor system, using 8 processors. Configurations with and without a tablet present were developed and examined. Simulations for a liquid-filled vessel at a paddle speed of 50 rpm were generated. Large variations in fluid velocity magnitudes with position in the vessel were evident. Fluid velocity predictions were in good agreement with those previously published, using laser Doppler velocity measurements. A low-velocity domain was evident directly below the center of the rotating paddle. The model was extended to simulate the impact of the presence of a cylindrical tablet in the base of the dissolution vessel. The presence of the tablet complicated the local fluid flow, and large fluid shear rates were evident at the base of the compact. Fluid shear rates varied depending on the tablet surface and the location on the surface and were consistent with the reported asymmetrical dissolution of model tablets. The approach has the potential to explain the variable dissolution results reported and to aid in the design/prediction of optimal dissolution conditions for in vitro--in vivo correlations.Keywords
This publication has 14 references indexed in Scilit:
- Sensitivity of dissolution rate to location in the paddle dissolution apparatusJournal of Pharmacy and Pharmacology, 2002
- Comparison of the mechanical destructive force in the small intestine of dog and humanInternational Journal of Pharmaceutics, 2002
- Influence of hydrodynamics and particle size on the absorption of felodipine in labradors.Pharmaceutical Research, 2002
- Dissolution Assay Development for in Vitro-in Vivo CorrelationsAdvances in experimental medicine and biology, 1997
- Improved Hydrodynamics for USP Apparatus 2Dissolution Technologies, 1996
- Fluid and Particle Laser Doppler Velocity Measurements and Mass Transfer Predictions for the Usp Paddle Method Dissolution ApparatusDrug Development and Industrial Pharmacy, 1990
- IN VITRO STUDIES ON THE DISSOLUTION AND ABSORPTION BEHAVIOUR OF ORALLY ADMINISTERED DRUGS, AND THE CONNECTION TO THEIR BIOAVAILABILITYPublished by Elsevier BV ,1976
- Development of In Vitro Dissolution Tests which Correlate Quantitatively with Dissolution Rate-Limited Drug Absorption in ManJournal of Pharmaceutical Sciences, 1965
- Effect of Certain Tablet Formulation Factors on Dissolution Rate of the Active Ingredient IJournal of Pharmaceutical Sciences, 1963
- Aspirin and gastric bleedingAmerican Journal Of Medicine, 1961