Softgel capsule technology as an enhancer device for the absorption of natural principles in humans. A bioavailability cross-over randomised study on silybin
Savio, D.; Harrasser, P.C.; Basso, G.
Arzneimittel-Forschung 48(11): 1104-1106
1998
ISSN/ISBN: 0004-4172 PMID: 9850434 Document Number: 1935
In order to evaluate if a patented soft gelatine capsule could improve the bioavailability of silybin (CAS 22888-70-6) in comparison to a hard shell capsule, an open, single dose, two-way, balanced cross-over study, was performed. The study was conducted on 12 healthy subjects (6 M and 6 F). 80 mg of silybin in a 1:2 complex with phosphatidylcholine was administered. Blood was sampled from the subjects in two occasions at the following times after drug administrations: 0 (sample before dosing), 1, 2, 3, 4, 6 and 8 h. The pharmacokinetic parameters calculated from the results of the plasma analyses demonstrated that the mean values of both Cmax and AUC0-t were increased when the patented soft gelatine capsule formulations were administered (i.e. Cmax more than 3-fold and AUC0-t more than 2-fold).
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