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 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 AUC0-1 were increased when the patented soft gelatine capsule formulations were administered (i.e. Cmax more than 3-fold and AUC0-1 more than 2-fold).
Savio
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EUCLIDEA S.r.I., Frascati, Rome, Italy.
Harrasser
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PC
Basso
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D000293:Adolescent; D000328:Adult; D000975:Antioxidants / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002214:Capsules; D018592:Cross-Over Studies; D005260:Female; D005782:Gels; D006801:Humans; D007408:Intestinal Absorption / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D012838:Silymarin / Q000008:administration & dosage / Q000493:pharmacokinetics*
D000975:Antioxidants; D002214:Capsules; D005782:Gels; D012838:Silymarin