Date

8-6-2025

Department

School of Health Sciences

Degree

Doctor of Philosophy in Health Sciences (PhD)

Chair

Matthew E. Ingle

Keywords

Polypodium leucotomos fern extract, physiologically based pharmacokinetic (PBPK) model, skin cancer, antioxidant, polyphenols, hydroxycinnamic acids, chlorogenic acids, caffeoylquinic acids, dihydrocaffeic acid

Disciplines

Biochemistry, Biophysics, and Structural Biology | Medicine and Health Sciences

Abstract

The purpose of this study was to develop an equation to calculate the approximate concentration of active components in orally administered Polypodium leucotomos fern extract (PLE) and to develop physiologically based pharmacokinetic (PBPK) models for an active component of PLE or its metabolite to address the need for human pharmacokinetics (PK). Model differences based on ethnic groups were also investigated. This was a quantitative study using secondary data. It has been estimated that skin cancers account for approximately 40% of all human cancers and that approximately 13,000 people will die of skin cancer in 2024. People with darker skin experience higher mortality from non-melanoma skin cancers than those with lighter skin. PK is the study of the absorption, distribution, metabolism, and excretion of xenobiotics. It is useful for dose characterization, safety determination, and determining the time course of the xenobiotic in the body. No in vivo human PK studies exist for PLE, so in silico PBPK models were developed using interspecies extrapolation and in vitro secondary data obtained from the literature. The models’ accuracy was also compared for people with lighter and darker skin. The accuracy of the PBPK models was assessed through graphical and mathematical statistical comparisons of the predicted PK profiles and parameters with those obtained from in vivo PK studies in the literature that used coffee, which is also an aqueous extract containing active components present in PLE. The models were accurate, suggesting they can be used for predicting concentrations in future PLE efficacy and safety studies.

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