Softgel capsule technology as an enhancer device for the absorption of natural principles in humans - A bioavailability cross-over randomised study on silybin

In order to evaluate if a patented soft gelatine capsule could improve the bioavailability of silybin (CAS 32888-70-6) in comparison to a hard shell c apsule, an open, single dose, two-way, balanced cross-over study, was perfo rmed. The study was conducted on 12 healthy subjects (6 M and 6 F). 80 mg of sily bin in a 1 :2 complex with phosphatidylcholine was administered. Blood was sampled from the subjects in two occasions at the following times after dru g administrations: 0 (sample before dosing), I, 2, 3, 4, 6 and 8 h. The pharmacokinetic parameters calculated from the results of the plasma an alyses demonstrated that the mean values of both C-max and AUC(0-t) were in creased when the patented soft gelatine capsule formulations were administe red (i.e. C-max more than 3-fold and AUC(0-t) more than 2-fold).