Preparation and Characterization of Phytosomal-Phospholipid Complex of P. Amarus and its Tablet Formulation

Abstract

Present investigation was aimed at formulation, characterization and evaluation of phytosomal complex tablets for sustained delivery of Phyllanthus amarus complex. Phyllanthin, one of the active lignin present in this plant species was isolated from the aerial parts, by silica gel column chromatography employing gradient elution with hexane −ethyl acetate solvent mixture. It was obtained in high yields (1.23%), compared to reported procedures and the purity was ascertained by HPTLC analysis. Phyllanthin was characterized for M.P, UV −Visible spectrophotometry, FT-IR, 1H NMR, 13C and NMR analysis. Release kinetics was evaluated by using United States Pharmacopeia (USP)-22 type I dissolution apparatus. Scanning electron microscopy was used to visualize the effect of dissolution medium on matrix tablet surface. HPTLC was carried out for quantitative and qualitative estimation of Phyllanthin in Phyllanthus amarus and Rf of phyllanthin was found to be about 0.25. The content was found to be maximum for phytosomal complex of phyllanthus formed by vaccum drying of 1:1 drug excipient ratio. The in-vitro drug release study revealed that optimized formulation sustained the drug release for 12 hr (88.1% ± 4.1% release). Fitting the in vitro drug release data to Korsmeyer equation indicated that diffusion along with erosion could be the mechanism of drug release.