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Published on: March 23, 2016
Formulation-dependent differences in systemic glutathione availability: Comparative pharmacokinetics of orally
Eun-Soo Jung1, Hui-Yeon Jang1, Su-Jin Jung1
1Clinical Trial Center for Functional Foods, Jeonbuk National University Hospital, 20 Geonjiro, Deokjin-gu, Jeonju 54907, South Korea; Biomedical Research Institute of Jeonbuk National University Hospital, 20 Geonjiro, Deokjin-gu, Jeonju 54907, South Korea.
Background:
Glutathione is a tripeptide involved in antioxidant defense; however, its systemic availability following oral administration remains controversial, and pharmacokinetic differences between formulations in humans are not well characterized.
Objective:
This study compared the pharmacokinetics and short-term supplementation effects of an orally dissolving film (ODF) and a conventional tablet formulation of glutathione in healthy adults.
Methods:
In Study I, a randomized open-label crossover trial evaluated single-dose (300 mg) pharmacokinetics following administration of ODF or tablets. In Study II, participants consumed ODF (100 mg/day) or tablets (100 mg/day) for 4 weeks.
Results:
Plasma glutathione concentrations were higher in the ODF group, with significant differences at 4 and 6 h. The ODF formulation showed a longer Tmax and tended toward higher Cmax and systemic exposure (iAUC0-6h). During 4-week supplementation, both formulations increased circulating glutathione levels, with no significant changes in oxidative stress-related biomarkers. No adverse events were reported.
Conclusions:
The ODF formulation exhibited a distinct pharmacokinetic profile and showed a trend toward greater systemic glutathione exposure compared with the tablet formulation. These findings suggest that formulation characteristics may contribute to differences in the bioavailability and pharmacokinetic behavior of orally administered glutathione.
Clinical Trial Registration:
Clinical Research Information Service (CRIS), KCT0011710.
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