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Characterization and Pharmacokinetic Assessment of a New Berberine Formulation with Enhanced Absorption In Vitro and in Human Volunteers

Solnier J, Zhang Y, Kuo YC, Du M, Roh K, Gahler R, Wood S, Chang C
Pharmaceutics 2023 15(11):2567

Bibliography

PubMed
PMID 38004546
PubMed Central
PMC10675484
Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Reported funding sources: Factors Group of Nutritional Companies. Grant and funder-role details are in the publication.
Competing interests
Disclosures include Factors Group ownership, consultancy, ISURA employment and formulation-related patent interests.

Study snapshot

DesignHuman formulation pharmacokinetic pilot with in-vitro characterization
ModelHuman participants; see population
Sample10 healthy volunteers
InterventionBerberine LipoMicel versus standard berberine; separate laboratory assays
DurationAcute 24-hour pharmacokinetic assessment
EndpointsPlasma exposure and pharmacokinetics; Drug interaction measurements; Short-term tolerability

What the study showed, in plain terms

The micellar preparation increased systemic exposure relative to the tested standard formulation.

Key findings

  • The micellar preparation increased systemic exposure relative to the tested standard formulation.

What this study can and cannot tell us

Small pilot and formulation-related commercial interests. An absorption increase does not demonstrate better clinical outcomes.

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