Evaluation of Silibinin Enriched Silymarin in Chronic HCV Patients

Abstract

Background/ Aim: Silymarin is a polyphenolic compound with anti-hepatotoxic activity. It has low oral bioavailability due to its poor aqueous solubility. Thus enhancement of its dissolution may lead to a better bioavailability. The objective of the presented study was to prepare fast dissolving enriched silymarin preparation via the preparation of enriched silymarin as solid dispersion and compare it with Legalon capsules in chronic HCV patients in a clinical study. Method: Enriched silymarin solid dispersion was prepared in sufficient amount. A clinical study was conducted including 24 patients. The patients were divided into two groups; each group had 12 patients. One group received the solid dispersion. The second group received Legalon capsules. Patients received capsules 3 times daily for 12 weeks. All these patients had been subjected to full medical history, abdominal ultrasonography, laboratory investigations and quality of life assessment at baseline and after treatment. Results: Solid dispersion had significantly faster dissolution rate. It is effective in reducing AST, ALT, total bilirubin, improving prothrombin concentration, prothrombin time and quality of life. Conclusion: Silymarin solid dispersion is a promising preparation. Large scale and longer duration may be required to ascertain its effects.