Co-Processed Chitin-Mannitol as a New Excipient for Oro-Dispersible Tablets

摘要

This study describes the preparation, characterization and performance of a novel excipient for use in oro-dispersible tablets (ODT). The excipient (>Cop–>CM) consists of chitin and mannitol. The excipient with optimal physicochemical properties was obtained at a chitin: mannitol ratio of 2:8 (w/w) and produced by roll compaction (RC). Differential scanning calorimetry (DSC), Fourier transform-Infrared (FT-IR), X-ray powder diffraction (XRPD) and scanning electron microscope (SEM) techniques were used to characterize >Cop–>CM, in addition to characterization of its powder and ODT dosage form. The effect of particle size distribution of >Cop–>CM was investigated and found to have no significant influence on the overall tablet physical properties. The compressibility parameter (a) for >Cop–>CM was calculated from a Kawakita plot and found to be higher (0.661) than that of mannitol (0.576) due to the presence of the highly compressible chitin (0.818). Montelukast sodium and domperidone ODTs produced, using >Cop–>CM, displayed excellent physicochemical properties. The exceptional binding, fast wetting and superdisintegration properties of >Cop–>CM, in comparison with commercially available co-processed ODT excipients, results in a unique multifunctional base which can successfully be used in the formulation of oro-dispersible and fast immediate release tablets.