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Abstract
Mosapride citrate (MSP) is a selective serotonin 5-HT4 receptor agonist with extremely low oral bioavailability (about 8%). The aim of this work is to improve the bioavailability of MSP through the preparation of MSP {u2013} pharmacosomes. MSP-pharmacosomes were prepared by refluxing weighed amount of MSP and phospholipids in a 100 ml rounded bottom flask containing tetrahydrofuran as reaction solvent, at 60 oC for 2 hours. N-octanol/water partition coefficient, in vitro mucoadhesion time, differential scanning calorimetry (DSC), Fourrier transform infra red spectroscopy (FTIR) and X-ray diffraction (XRD) were investigated for the prepared MSP-pharmacosomes. Results revealed that there was a remarked increase in partition coefficient, n-octanol solubility and in vitro mucoadhesion time of Mosapride citrate-pharmacosomes compared to Mosapride citrate. The best three formulae CP6, CP5 and CP7 were selected to be incorporated in sublingual fast dissolving mucoadhesive tablet prepared by Zydis technology with some modification was used to prepare the tablets. The prepared tablets were characterized regarding in -vitro disintegration, in-vitro dissolution, wetting time, bioadhesion time and bioadhesion force. Results of this chapter revealed that T2 tablets had the best in vitro performance. Finally, a study for the in-vivo behavior of Mosapride citrate in human volunteers was carried out to compare its pharmacokinetics following the sublingual administration of the market product Fluxopride® 5 mg tablets and the prepared fast dissolving mucoadhesive MSP pharmacosomal tablet (T2)