Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

In-vivo Kinetics of Silymarin (Milk Thistle) on Healthy Male Volunteers

Muhammad Usman , Mahmood Ahmad, Asad Ullah Madni, Naveed Akhtar, Waheed Asghar, Muhammad Akhtar, M Atif, M Qamar-uz-zaman

Department of Pharmacy, the Islamia University of Bahawalpur, Punjab, Pakistan;

For correspondence:- Muhammad Usman Email: minhasiub@hotmail.com Tel:092629255243

Received: 24 January 2009 Accepted: 24 April 2009 Published: 14 August 2009

Citation: Usman M, Ahmad M, Madni AU, Akhtar N, Asghar W, Akhtar M, et al. In-vivo Kinetics of Silymarin (Milk Thistle) on Healthy Male Volunteers. Trop J Pharm Res 2009; 8(4):311-316 doi: 10.4314/tjpr.v8i4.4

© 2009 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

Abstract

Purpose: The study was aimed at evaluating the in vivo kinetics of silymarin tablets, a product with anti-hepatotoxic 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 C_maxof 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 (C_max) is not an important consideration.

Keywords: In vivo kinetics, Silymarin, Milk thistle, RP-HPLC, Pharmacokinetics