琥珀酸索利那新片的制备及处方优化

Preparation and Formulation Optimization of Solifenacin Succinate Tablets

目的对琥珀酸索利那新片处方与工艺进行优化。方法通过设计不同处方,对粘合剂、填充剂、润滑剂的用量及包衣工艺进行考察,确定了最终处方,并测定在4种溶出介质中的溶出曲线。结果以琥珀酸索利那新为主药,以乳糖、淀粉为填充剂,以羟丙基甲基纤维素为粘合剂,以硬脂酸镁为润滑剂,以胃溶型薄膜包衣预混剂为包衣材料,制得琥珀酸索利那新片。结论该制剂工艺稳定,制得琥珀酸索利那新片(5mg)与原研市售品溶出行为相似,质量符合规定。

OBJECTIVE To explore the formulation and process optimization of Solifenacin Succinate tablets. METHODS Through the design of different prescriptions and the selection of the amount of binders,fillers,lubricant and coating process were investigated to determine the final formulation,and dissolution profile was measured in four kinds of dissolution media. RESULTS Solifenacin Succinate tablets were formulated with Solifenacin Succinate as the main drug,lactose and starch as fillers,hydroxypropylmethylcellulose as binders,stearic magnesium as lubricant,film coating premixed adjuvant（ gastric-dissolving type） as the coating material. CONCLUSION The present formulation process of newly developed Solifenacin Succinate tablets was stable. The dissolution behavior of newly developed formulation was similar to that of the originally commercial product. The quality complies with the provisions.