CRITICAL EVALUATION OF MODIFIED-RELEASE FORMULATION CONTAINING SILYBUM MARIANUM EXTRACT FOR ORAL APPLICATION
DÁVID SINKA 1#, ALEXANDRA HAGYMÁSI 1, PÁLMA FEHÉR 1, ZOLTÁN UJHELYI 1, MIKLÓS VECSERNYÉS 1, FERENC FENYVESI 1, JUDIT VÁRADI 1, GÁBOR VASVÁRI 1, TÜNDE JURCA 2, SEBASTIAN NEMETH 2#, DANIELA ELENA POPA 3#, ILDIKÓ BÁCSKAY 1*
1.Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Debrecen, Debrecen, Hungary
2.Department of Pharmacy, Faculty of Medicine and Pharmacy, University of Oradea, Oradea, Romania
3.Department of Drug Control, Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
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Silymarin is the extract of active ingredients of the plant Silybum marianum. It is used in medicine for curing or preventing
liver and gall diseases for thousands of years. Silymarin has a low solubility and permeability, belongs to BCS class IV. Its
current pharmacotherapy means conventional dosage forms such as capsules, but it results in low bioavailability. Our main
goals through the research were to formulate matrix tablets with silymarin as active ingredient. We used different carbopols
as matrix-forming polymers. The complexation of silymarin with different β-cyclodextrins was intended to increase the
solubility of the active ingredient. By achieving sustained release, our aim was to offer a better alternative than the
conventional unsuccessful oral therapy. Comparing the results of our research, we could select the carbopol-cyclodextrin
combination with the optimal drug release from the twenty different compounds. With these compositions, more than 85% of
the silymarin was dissolved. The cytocompatibility of our product was proven, and the technology provided much better
bioavailability than the conventional silymarin therapy.
