Research Article

Development of an Innovative Berberine Food-Grade Formulation with an Ameliorated Absorption: In Vitro Evidence Confirmed by Healthy Human Volunteers Pharmacokinetic Study

Table 3

Pharmacokinetic parameters.

ParametersABC

Free berberine
AUClast (pg/mLh)1057 ± 1172544 ± 3324146 ± 431
Cmax (pg/mL)69.95 ± 14.54199.87 ± 26.97375.57 ± 41.56§
Tmax (h)4.55 ± 0.293.15 ± 0.304.50 ± 0.30
MRT (h)12.13 ± 0.199.16 ± 0.179.53 ± 0.26

Total berberine
AUClast (pg/mLh)1217 ± 1294952 ± 6478212 ± 893§
Cmax (pg/mL)76.70 ± 14.04316.88 ± 26.60572.14 ± 64.26§
Tmax (h)3.59 ± 0.342.13 ± 0.333.10 ± 0.34
MRT(h)NCNCNC

Results are expressed as mean ± S.E.M.; NC: not calculable. Statistical analysis was performed by one-way ANOVA, followed by Tukey’s test. versus A, versus B, and versus C. Formulations: A: berberine chloride alone 500 mg (equivalent to 452 mg of berberine); B: BBR-PP 550 mg (equivalent to 188 mg of berberine) one film-coated tablet; C: BBR-PP 550 mg (equivalent to 188 mg berberine) two film-coated tablets. Twelve healthy volunteers of both sexes with a mean age of 29 ± 7.72 and a mean BMI of 23.09 ± 1.27 were enrolled.