Preparation, In Vitro and Ex Vivo Evaluation of MucoadhesiveBuccal Films of Silibinin
karbala journal of pharmaceutical sciences,
2013, Volume 4, Issue 4, Pages 1-10
AbstractSilibinin is a major biologically active compound present in the Compositae family of plants with promising antinflammatory activity. The purpose of this study was to develop and optimize formulations of mucoadhesivefilms of silibinin to be used for buccal ulcer.Twelve film formulas were prepared by the solvent casting method using several polymers namely: sodium carboxymethylcellulose (SCMC), polyvinylpyrolidone (PVP), polyvinyl alcohol (PVA), carbopol 934, Eudragit E-100, and sodium alginate at various ratios. The prepared films were characterized in terms of film thickness, weight variation, swelling capacity, surface pH,drugcontent uniformity, ex vivo adhesion time, bioadhesive strength, folding endurance, in vitro drug release, and drug-exicpient compatibility using FTIR. The in vitro release studies were conducted for silibininfilms in phosphate buffer-pH-6.6 solution.The films were found to be smooth in texture, uniform in thickness, weight, and drug content with acceptable surfacepH. The film formula (F12) containing combination of two polymers PVP: PVA in ratio of 1:3with 0.3%v/v propylene glycol showed good mucoadhesion properties with maximum release of 95% within 4 hours. The diffusion exponent (n) of KrosmeyerPeppas for best formulation was found to be 0.52 which indicates the mechanism of drug release was anomalous transport. Optimized formulation was checked for stability and was found to be stable with expired date about3.6 years. Thus the selected formula can serve as a good candidate for buccal dosage form of silibinin.
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