MRI Studies of the Hydrodynamics in a USP 4 Dissolution Testing Cell

Shiko, G.; Gladden, Lynn F.; Sederman, Andrew J.; Connolly, Paul; Butler, James

doi:10.1002/jps.22343

Cited by 43 publications

(20 citation statements)

References 62 publications

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“…H ydrodynamics in USP dissolution Apparatus 4 have been analyzed theoretically using computational fluid dynamics (CFD) and imaging techniques such as magnetic resonance imaging (MRI) (1)(2)(3)(4). An important point to recognize when considering hydrodynamics in the flow-through apparatus is the low-velocity operating conditions.…”

Section: Introductionmentioning

confidence: 99%

Hydrodynamic Complexity Induced by the Pulsing Flow Field in USP Dissolution Apparatus 4

D’Arcy¹,

Liu²,

Persoons³

et al. 2011

Dissolution Technol.

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USP dissolution Apparatus 4 can have a pulsing or non-pulsing flow, with most commercial apparatus employing a pulsing flow. Overall, a low velocity flow field is present, particularly in the larger 22.6-mm diameter cell. Dissolution data, computational fluid dynamics (CFD), and imaging methods are used and discussed to investigate the effects of low velocity pulsing flow on dissolution. Local velocity patterns, density gradients, and the effect of flow rate on particulate dispersion can all contribute to the observed dissolution rate. In silico simulation tools and imaging techniques have proved useful in determining local hydrodynamics and, in some cases, their effect on observed dissolution rates. Methods to investigate concentration gradients at the dissolving surface are required to investigate further the effect of hydrodynamics on the dissolution process. In conclusion, it is necessary to take local flow patterns and velocities into account, rather than overall flow rate alone, when interpreting dissolution rate data in the flow-through apparatus.

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Section: Introductionmentioning

confidence: 99%

Hydrodynamic Complexity Induced by the Pulsing Flow Field in USP Dissolution Apparatus 4

D’Arcy¹,

Liu²,

Persoons³

et al. 2011

Dissolution Technol.

View full text Add to dashboard Cite

show abstract

“…Fluid velocities around a tablet oriented both horizontally and vertically in the Ø12 mm cell at 8 mL/min were also described. The horizontally oriented tablet experienced increased axial and radial fluid velocities due to the reduced crosssectional area available for flow, and radial velocity distributions differed over the course of the pulse, depending on tablet orientation, with greater variation around the vertically oriented tablet (56). The effect of variation in hydrodynamics relative to tablet orientation was previously presented in terms of observed effects on dissolution.…”

Section: Flow-through Dissolution Apparatusmentioning

confidence: 89%

“…MRI has been used to visualize and quantify flow in the FTC apparatus, both with and without a cylindrical disk "tablet" (representing the dosage form) in the cell (56). A very detailed description of observed hydrodynamics is provided by Shiko et al (56).…”

Section: Flow-through Dissolution Apparatusmentioning

confidence: 99%

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Characterization and Simulation of Hydrodynamics in the Paddle, Basket and Flow-Through Dissolution Testing Apparatuses - A Review

Todaro¹,

Pearsons²,

Grove³

et al. 2017

Dissolution Technol.

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Fluid velocity local to the dissolving surface will affect the dissolution rate. It is difficult to anticipate what local fluid velocities are present within compendial dissolution apparatuses from set flow rates or stirring rates. A range of qualitative and quantitative velocimetric techniques are available to assess and characterize hydrodynamics. These methods are frequently used in combination with computational fluid dynamics simulations to characterize and simulate hydrodynamics. Dosage form location and motion varies between apparatuses, and the presence of the dosage form itself can impact local hydrodynamics. Each apparatus described has identified hydrodynamic features which may also vary with agitation rate. This review describes the methods used to simulate and characterize hydrodynamics and summarizes some of the main findings from studies investigating hydrodynamics in the paddle, basket, and flowthrough dissolution apparatuses.

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“…It is important in process control, quality assurance and to determine reliable release characteristics of the product over time [1,2]. Dissolution tests have also been applied as a tool to predict drug product performance in vivo as a result of attempts to minimize costly in vivo bioequivalence studies required to approve a new drug product [3,4]. The basket and paddle methods are currently the most widely used dissolution techniques.…”

Section: Introductionmentioning

confidence: 99%

Comparison of Flow-Through Cell and Paddle Methods for Testing Vaginal Tablets Containing a Poorly Water-Soluble Drug

Szymańska¹,

Winnicka²

2013

Trop. J. Pharm Res

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MRI Studies of the Hydrodynamics in a USP 4 Dissolution Testing Cell

Cited by 43 publications

References 62 publications

Hydrodynamic Complexity Induced by the Pulsing Flow Field in USP Dissolution Apparatus 4

Hydrodynamic Complexity Induced by the Pulsing Flow Field in USP Dissolution Apparatus 4

Characterization and Simulation of Hydrodynamics in the Paddle, Basket and Flow-Through Dissolution Testing Apparatuses - A Review

Comparison of Flow-Through Cell and Paddle Methods for Testing Vaginal Tablets Containing a Poorly Water-Soluble Drug

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