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PhysioCell — a Novel, Bio-relevant Dissolution Apparatus: Hydrodynamic Conditions and Factors Influencing the Dissolution Dynamics

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A Correction to this article was published on 21 March 2023

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Abstract

The physiologically relevant dissolution apparatuses simulate various aspects of gastrointestinal physiology and help to understand and predict the in vivo behavior of an oral dosage form. In this paper, we present and characterize for the first time a novel bio-relevant dissolution apparatus — PhysioCell. We evaluated the impact of several factors on the hydrodynamic conditions in the key vessel of the apparatus — the StressCell. We observed that the medium flow rate, but not the glass beads’ size or amount, significantly influenced the dissolution rate. The relationship was disproportional: the increase in the flow rate from 4.6 to 9.0 mL/min reduced the dissolution time of 85% (T85) of the NaCl tablet by 46%, but from 134 to 300 mL/min decreased the T85 only by 24%. At the same time, the contractions of the StressCell’s elastic walls promoted the content mixing and enhanced the dissolution rate of the paracetamol tablets: even very rare mixing contractions (1 per 10 min) decreased the T85 over twofold for the flow rate of 8 mL/min. In conclusion, the hydrodynamic conditions in the StressCell affect the dissolution of solid dosage forms and the understanding of these effects is crucial for modeling physiologically-based test conditions in the novel apparatus. Combinations of the unique PhysioCell features — adjustable medium flow, temperature control, controllable pH gradients and predefined mechanical agitation — can create a set of dissolution test scenarios for characterization of oral dosage forms and, in the future, making the in vitro-in vivo predictions.

Visualisation of the operating parameters of the PhysioCell that were examined in this study.

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Acknowledgements

The authors would like to kindly thank Prof. Sebastian Polak, PhD Grzegorz Banach and PhD Jadwiga Paszkowska for critically reviewing the final version of the manuscript.

Funding

The work has been partially financed by Polish National Centre for Research and Development (POIR.01.02.00-00-0011/17).

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Authors and Affiliations

  1. Physiolution Polska, 74 Pilsudskiego St., 50-020, Wroclaw, Poland

    Marcela Staniszewska, Justyna Dobosz, Bartosz Kołodziej, Uladzimir Lipski & Grzegorz Garbacz

  2. Department of Physical Pharmacy and Pharmacokinetics, Poznan University of Medical Sciences, 3 Rokietnicka St., 60-806, Poznan, Poland

    Michał Romański & Dorota Danielak

Authors
  1. Marcela Staniszewska
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  2. Michał Romański
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  3. Justyna Dobosz
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  4. Bartosz Kołodziej
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  5. Uladzimir Lipski
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  6. Grzegorz Garbacz
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  7. Dorota Danielak
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Contributions

Conceptualization: Marcela Staniszewska, Grzegorz Garbacz. Methodology: Marcela Staniszewska, Justyna Dobosz, Bartosz Kołodziej, Uladzimir Lipski. Formal analysis and investigation: Marcela Staniszewska, Grzegorz Garbacz. Writing — original draft preparation: Marcela Staniszewska, Dorota Danielak. Writing — review and editing: Michał; Romański, Grzegorz Garbacz. Funding acquisition: Grzegorz Garbacz. Supervision: Dorota Danielak, Grzegorz Garbacz.

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Correspondence to Marcela Staniszewska.

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The original article has been updated to correct Michał Romański and Bartosz Kołodziej names by including Polish characters. Previously published article.

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Staniszewska, M., Romański, M., Dobosz, J. et al. PhysioCell — a Novel, Bio-relevant Dissolution Apparatus: Hydrodynamic Conditions and Factors Influencing the Dissolution Dynamics. AAPS PharmSciTech 24, 65 (2023). https://doi.org/10.1208/s12249-022-02494-4

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