Preparation and in vitro quality evaluation of risperidone nasal gel / 中国药学杂志

ABSTRACT

OBJECTIVE: To prepare a nasal gel of risperidone (RIS) and evaluate its in vitro quality. METHODS: The formulation and preparation process of RIS nasal gel were optimized with orthogonal test using appearance,spreading ability and in vitro release as main evaluation indexes. The quality items of the optimized RIS nasal gel such as appearance,pH value,contents of RIS and preservative,in vitro release and related substances were then evaluated. RESULTS: The optimal formulation of the RIS nasal gel consisted of 0.5% RIS, 0.35% carbopol 940, 0.5% chlorobutanol,20% propanediol and 15% DM-β-CD and appropriate amount of purified water. Its ideal pH value was about 6.0. Furthermore,the quality items such as the appearance,pH value,contents of RIS and preservative,in vitrorelease and related substances of the preparation all conformed to the relevant quality requirements in China Pharmacopiea (2010). CONCLUSION: The RIS nasal gel will be a promising new preparation for nasal administration due to its reasonable formulation,simple preparation process and controllable quality.