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

Arzneimittelforschung. 1998 Nov;48(11):1104-6.

Abstract

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).

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Antioxidants / administration & dosage
  • Antioxidants / pharmacokinetics*
  • Area Under Curve
  • Biological Availability
  • Capsules
  • Cross-Over Studies
  • Female
  • Gels
  • Humans
  • Intestinal Absorption / drug effects*
  • Male
  • Middle Aged
  • Silymarin / administration & dosage
  • Silymarin / pharmacokinetics*

Substances

  • Antioxidants
  • Capsules
  • Gels
  • Silymarin