Barrier model selection alters apparent diclofenac permeation parameters: a controlled in vitro comparison of Strat-M® and a HaCaT-based epidermal construct
- 1Institute of Biomedical Sciences, Faculty of Medicine, University of Maribor
- 2Department of Pharmacology, Faculty of Medicine, University of Maribor
Abstract
Introduction: Synthetic membranes and keratinocyte-based constructs are both used as accessible alternatives to ex vivo skin in in vitro permeation testing (IVPT), but they have not been compared directly for the same marketed products under identical conditions. This pilot study directly compared the synthetic Strat-M® membrane and a HaCaT construct under identical IVPT conditions using Voltaren® and Olfen®, two marketed, nominally dose-equivalent diclofenac gels. The aim was to determine whether the two barrier models yielded consistent apparent permeation parameters and led to the same comparative interpretation of the two formulations.
Methods: Permeation studies were performed using Franz diffusion cells in an internally controlled experimental design. Both formulations were tested in triplicate under identical conditions, including receptor medium, temperature, sampling protocol, and analytical method. Steady-state flux (Jss), permeability coefficient (Kp), lag time ( t lag), and cumulative permeation profiles were determined and compared between barrier models.
Results: Barrier model selection affected the apparent permeation behavior of diclofenac. Strat-M® detected a statistically significant difference in steady-state flux between Voltaren® and Olfen®, whereas no statistically significant between-formulation difference was detected with the HaCaT construct under the same experimental conditions. Lag time was the parameter most strongly influenced by barrier selection and was consistently shorter with the HaCaT construct than with Strat-M®.
Discussion: Under identical IVPT conditions, Strat-M® and the HaCaT-based epidermal construct generated different apparent permeation profiles and yielded different comparative assessments of Voltaren® and Olfen®. This model-dependent divergence underscores the need to justify barrier selection explicitly and to consider its limitations when interpreting comparative IVPT data.
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BibTeX
@article{dugonik2026barrier,
title = {{Barrier model selection alters apparent diclofenac permeation parameters: a controlled in vitro comparison of Strat-M® and a HaCaT-based epidermal construct}},
author = {Filip Dugonik and Urška Jeršič and Lejla Kač and Lidija Gradišnik and Tanja Zidarič and Uroš Maver and Tina Maver},
journal = {Frontiers in Pharmacology},
year = {2026},
month = oct,
doi = {10.3389/fphar.2026.1934405},
url = {https://www.frontiersin.org/articles/10.3389/fphar.2026.1934405/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Barrier model selection alters apparent diclofenac permeation parameters: a controlled in vitro comparison of Strat-M® and a HaCaT-based epidermal construct
AU - Filip Dugonik
AU - Urška Jeršič
AU - Lejla Kač
AU - Lidija Gradišnik
AU - Tanja Zidarič
AU - Uroš Maver
AU - Tina Maver
PY - 2026
DA - 2026/10/07
JO - Frontiers in Pharmacology
DO - 10.3389/fphar.2026.1934405
UR - https://www.frontiersin.org/articles/10.3389/fphar.2026.1934405/full
AB - Introduction: Synthetic membranes and keratinocyte-based constructs are both used as accessible alternatives to ex vivo skin in in vitro permeation testing (IVPT), but they have not been compared directly for the same marketed products under identical conditions. This pilot study directly compared the synthetic Strat-M® membrane and a HaCaT construct under identical IVPT conditions using Voltaren® and Olfen®, two marketed, nominally dose-equivalent diclofenac gels. The aim was to determine whether the two barrier models yielded consistent apparent permeation parameters and led to the same comparative interpretation of the two formulations. Methods: Permeation studies were performed using Franz diffusion cells in an internally controlled experimental design. Both formulations were tested in triplicate under identical conditions, including receptor medium, temperature, sampling protocol, and analytical method. Steady-state flux (Jss), permeability coefficient (Kp), lag time ( t lag), and cumulative permeation profiles were determined and compared between barrier models. Results: Barrier model selection affected the apparent permeation behavior of diclofenac. Strat-M® detected a statistically significant difference in steady-state flux between Voltaren® and Olfen®, whereas no statistically significant between-formulation difference was detected with the HaCaT construct under the same experimental conditions. Lag time was the parameter most strongly influenced by barrier selection and was consistently shorter with the HaCaT construct than with Strat-M®. Discussion: Under identical IVPT conditions, Strat-M® and the HaCaT-based epidermal construct generated different apparent permeation profiles and yielded different comparative assessments of Voltaren® and Olfen®. This model-dependent divergence underscores the need to justify barrier selection explicitly and to consider its limitations when interpreting comparative IVPT data.
SN - 1663-9812
ER -