Preparation of ebastine dispersible tablets by hot-melt dispersion / 药学实践杂志

ABSTRACT

Objective To prepare ebastine dispersible tablets by hot-melt dispersion method using hypromellose as a carrier.Methods Ebastine was heated to melt and dispersed in hot solution of hypromellose.The mixture was adsorbed by mannitol and then used to prepare dispersible tablets.The characteristics of hot-melt dispersion were analyzed by the methods of differential scanning calorimetry and X-ray powder diffraction.A comparison of dissolution curves between self-made dispersible tablets and original ebastine tablets was performed.Results The analysis of X-ray diffraction and differential scanning calorimetry showed that the ebastine in solid matrix remained the main crystalline characteristics.The dissolution of ebastine hot-melt dispersion was 95.07％ in 15 min in vitro, which was significantly higher than that of micronized ebastine raw material.Moreover, the accumulative dissolution of ebastine dispersible tablets in 30 min was about 30％ higher than the original drug.Conclusion The method of hot-melt dispersion using hypromellose as a carrier improved the ebastine dissolution significantly.