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Amisulpride exhibits anti-psychotic activities by selectively binding to dopamine D(2) and D(3) receptors in the limbic system. It is used in the treatment of psychoses, paranoid, productive schizophrenias, dysthymia. However, amisulpride (AMP) is poorly water soluble drug, so solubility is the main constraint for oral bioavailability. An attempt has been made to increase the solubility of this drug by formulating solid dispersion (SD) by using β-cyclodextrin (β-CD) employing spray drying method and then formulating fast dissolving tablets(FDT). Among the two different formulation of SD, formulation SD2 containing amisulpride & β-CD in the ratio of 1:2 gives best drug content and dissolution profile and among tablet formulations. FDTs were prepared by direct compression technique using superdisintegrants such as croscarmellose sodium and sodium starch glycolate in different concentrations. SDs were characterized by FT-IR, DSC analysis and evaluated for drug content and in vitro dissolution profiles. Tablet formulations were evaluated for pre compressional parameters such as angle of repose, bulk & tap density, Carr’s index, Hausner’s ratio and post compression parameters such as hardness, friability, weight variations, drug content, wetting time, disintegration time and in vitro dissolution profile. Formulation CF2 containing 6.5% croscarmellose sodium gives best disintegration and dissolution profile compared with other formulations. Results showed that β-cyclodextrin is a promising polymer for enhancing the solubility of AMP
Amisulpride, β-cyclodextrin, solid dispersion, super disintegrants, direct compression, fast dissolving tablet
Amisulpride, β-cyclodextrin, solid dispersion, super disintegrants, direct compression, fast dissolving tablet
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