In-vivo Kinetics of Silymarin (Milk Thistle) on Healthy Male Volunteers
Abstract
Purpose: The study was aimed at evaluating the in vivo kinetics of silymarin tablets, a product with antihepatotoxic and free radical scavenging activities.Methods: Silimarin® (Amson Vaccines & Pharma Pvt Ltd) was used as the test product while another silymarin tablet brand, Silliver® (Abbott Laboratories Pak Ltd) was the reference product. The tablets were administered to healthy male volunteers orally at a dose of 200 mg following an overnight fast according to a randomized cross-over design. Scheduled blood samples were collected, centrifuged and the plasma assayed using a sensitive and validated reversed phase high performance liquid chromatographic (RP-HPLC) method. Various pharmacokinetic parameters were calculated based on the non-compartmental model.
Results: Non-significant difference (p < 0.05) was observed in the area under the curve (AUC) of the two brands with values of 10.8 ± 0.4 μg h/ml and 11.2 ± 0.7 μg h/ml, respectively. There was, however, a significant difference (p < 0.05) in the Cmax of the two brands. Other pharmacokinetic parameters evaluated did not show any statistical difference (p < 0.05) between the two products except for mean
residence time Conclusion: The test product can be used as an alternative to the brand, Silliver®-Abbot (reference), only in conditions where maximum plasma concentration (Cmax) is not an important consideration.
Submission of a manuscript to this journal is a representation that the manuscript has not been published previously and is not under consideration for publication elsewhere.
All authors named in each manuscript would be required to sign a form (to be supplied by the Editor) so that they may retain their copyright in the article but to assign to us (the Publishers) and its licensees in perpetuity, in all forms, formats and media (whether known or created in the future) to (i) publish, reproduce, distribute, display and store the contribution, (ii) translate the contribution into other languages, create adaptations, reprints, include within collections and create summaries, extracts and/or abstracts of the contribution, (iii) create any other derivative works(s) based on the contribution, (iv) to exploit all subsidiary rights in the contribution, (v) the inclusion of electronic links from the contribution to third party material where-ever it may be located, and (vi) license any thrid party to do any or all of the above.