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A New Approach to Dissolution Testing by UV Imaging and Finite Element Simulations

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ABSTRACT

Purpose

Most dissolution testing systems rely on analyzing samples taken remotely from the dissolving sample surface at different time points with poor time resolution and therefore provide relatively unresolved temporally and spatially information on the dissolution process. In this study, a flexible numerical model was combined with a novel UV imaging system, allowing monitoring of the dissolution process with sub second time resolution.

Methods

The dissolution process was monitored by both effluent collection and UV imaging of compacts of paracetamol. A finite element model (FEM) was used to characterize the UV imaging system.

Results

A finite element model of the UV imaging system was successfully built. The dissolution of paracetamol was studied by UV imaging and by analysis of the effluent. The dissolution rates obtained from the collected effluent were in good agreement with the numerical model. The numerical model allowed an assessment of the ability of the UV imager to measure dissolution—time profiles. The simulation was able to extend the experimental results to conditions not easily obtained experimentally.

Conclusions

Combining FEM,experimental dissolution data and UV imaging provided experimental validation of the FEM model as well as a detailed description of the dissolution process.

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Abbreviations

A:

radius of circular compact

C:

concentration

Csat :

saturation concentration

d:

flow channel width

D:

diffusion coefficient

DH :

hydraulic diameter

F:

mass flux of dissolving compound

FEM:

finite element method

H:

characteristic length defined as the height of the flow cell over the compact

J:

dissolution rate

Pe:

Peclet number

Ps :

shear Peclet number

Q:

volumetric flow rate

Re:

Reynolds number

u:

velocity

U:

average linear flow rate

USP:

United States pharmacopeia

UV:

ultraviolet

Vf :

volumetric flow rate

ν:

kinematic viscosity

ρ:

density

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Authors and Affiliations

  1. Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 2, 2100, Copenhagen, Denmark

    Johan P. Boetker, Jukka Rantanen, Thomas Rades, Anette Müllertz, Jesper Østergaard & Henrik Jensen

Authors
  1. Johan P. Boetker
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  2. Jukka Rantanen
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  3. Thomas Rades
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  4. Anette Müllertz
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  5. Jesper Østergaard
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  6. Henrik Jensen
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Corresponding author

Correspondence to Henrik Jensen.

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Boetker, J.P., Rantanen, J., Rades, T. et al. A New Approach to Dissolution Testing by UV Imaging and Finite Element Simulations. Pharm Res 30, 1328–1337 (2013). https://doi.org/10.1007/s11095-013-0972-0

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  • DOI: https://doi.org/10.1007/s11095-013-0972-0

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