Abstract
Objective To evaluate the effect of Polyethylene glycol and β-cyclodextrin on the solubility and dissolution of silymarine, a poorly water soluble herbal drug. Methodology Effects of beta cyclodextrins and Polyethylene glycol on solubility of sylimarine were evaluated by phase solubility studies both separately as well as in combination. Solid inclusion complexes of silymarine –β-cyclodextrin in 1:1 molar ratio were prepared with and without polyethylene glycol by kneading method then evaluated for solubility dissolution and physical nature by XRD, FT-IR and NMR spectroscopy studies. Results The aqueous solubility of silymarine was linearly increased as a function of the concentration of β-cyclodextrin alone and in the presence of polyethylene glycol. Beta cyclodextrin formed molecular inclusion complexes with sylimarine in1:1 molar ratio as revealed by phase solubility diagram. The ternary complexes of silymarine, β-cyclodextrin and polyethylene glycol demonstrated better dissolution than those of silymarine and its binary complexes with β-cyclodextrin alone. Silymarine - β-cyclodextrin complex caused 1.3 fold increase in the dissolution rate of silymarine, which was further increased up to 1.7 fold in presence of small amount of polyethylene glycol. Conclusion The presence of polyethylene glycol markedly enhances the molecular complexation and solubilizing efficiencies of β-cyclodextrin on sylimarine.
Highlights
Silymarin (SLM) is mixture of flavonoids and other polyphenolic compounds extracted from the seeds of Silybum marianum (Morazzoni and Bombardelli, 1995)
The aqueous solubility of silymarin was linearly increased as a function of the concentration of β-cyclodextrin alone and in the presence of polyethylene glycol
The Phase solubility diagram of SLM in aqueous βCD and PEG 6000 solutions were shown in Fig.1 and Fig 2 respectively
Summary
Silymarin (SLM) is mixture of flavonoids and other polyphenolic compounds extracted from the seeds of Silybum marianum (Morazzoni and Bombardelli, 1995). Silymarin is one of the few herbal drugs which have been extensively studied due to its wide pharmacological actions, (Saller et al, 2001; Fraschini et al, 2002; Yang et al, 2003; Rao and Viswanath, 2007). It exhibits low and variable bioavailability due to its poor aqueous solubility and it require enhancement in the Ansari et al / Journal of Applied Pharmaceutical Science 5 (09); 2015: 026-031. In the present investigation the individual main effects and combined (or interaction) effect of BCD and PEG 6000 on the solubility and dissolution rate of SLM were investigated
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