仿制药盐酸胍法辛缓释片的制备及体外评价

目的 制备仿制药物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 根据CFDA颁布的仿制药研究和评价相关指导原则为导向，结合原研药品处方的分析，对仿制药的体外药物释放、稳定性和工艺进行单因素研究。结果 用筛选得到的最佳处方完成盐酸胍法辛缓释片商业化批量的生产，可实现仿制药与原研药品在多种介质下释药曲线相似，同时满足小规格品种的BE豁免需求。结论 自研药物盐酸胍法辛缓释片处方设计合理，制剂制备工艺可行。

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

ABSTRACT: OBJECTIVE To prepare guanfacine extended-release tablets and study the development way of generics extended-release. 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 dissolution profiles, stability and process. RESULTS The optimal formulation have the acceptable attributes for commercialization. The in vitro performance of the product being developed showed comparable properties to the reference listed drug. Dissolution profiles among all strengths are comparable, thus enables waiver of in vivo studies of non BE strengths. CONCLUSION The formulation and technology of guanfacine extended-release tablets is properly developed.