仿制药盐酸胍法辛缓释片的制备及体外评价

Preparation and in Vitro Evaluation of Generics of Guanfacine Hydrochloride Extended-release Tablets

目的制备仿制药盐酸胍法辛缓释片,并探究仿制缓释制剂处方开发思路。方法以CFDA等发布的仿制药研究和评价相关指导原则为导向,结合参比制剂处方进行分析,对仿制药的体外释放度、稳定性和工艺进行研究。结果用筛选得到的最佳处方完成盐酸胍法辛缓释片的批量生产,可实现仿制药与参比制剂在多种介质下释药曲线相似,同时满足小规格仿制药的生物等效性豁免需求。结论仿制药盐酸胍法辛缓释片处方设计合理,制剂制备工艺可行。

OBJECTIVE To prepare generics of guanfacine hydrochloride extended-release tablets and study the development way of generics extended-release prescription. METHODS Following the guiding principles of the CFDA on generics research and analysis of the reference listed drug, the formulation was proposed and evaluated with regards to the in vitro release, stability and technology. RESULTS The optimal formulation had the acceptable attributes for mass production. Ggeneric drugs and reference preparation can be released in a variety of media similar curves, while meeting the bioequivalency exemption requirements of small qenerics. CONCLUSION The formulation and technology of guanfacine extended-release tablets is properly developed.