碳酸司维拉姆分散片制备处方工艺研究

Prescription Technology Research of Sevelamer Carbonate Dispersible Tablets

关键词:  碳酸司维拉姆  分散片  DOE设计  处方工艺

Key words:  sevelamer carbonate  dispersible tablets  DOE design  prescription technology

摘要:

目的 筛选碳酸司维拉姆分散片的最优处方，制备成分散片，解决该药品普通片造成患者吞咽困难以及食道异常等方面的问题。方法 根据辅料特性选择交联聚乙烯吡咯烷酮（crosslinked polyvinylpyrrolidone，PVPP）为崩解剂，微晶纤维素为赋形剂，聚维酮K-30为黏合剂，硬脂酸镁为润滑剂，阿斯巴甜和柠檬香精为矫味剂的分散片处方；通过DOE设计对处方进行筛选，以分散均匀性和溶出度作为指标考察。结果 筛选得到原料粒径（D90）为15.0 μm，PVPP占比45.0%，硬脂酸镁占比0.6%组成最优处方。结论 研制的碳酸司维拉姆分散片处方合理、工艺可行，药品符合质量标准要求。

Abstract:

OBJECTIVE To prepare sevelamer carbonate into dispersible tablets and to screen its optimal prescription to solve the problems of dysphagia and abnormal esophagus caused by conventional tablets in patients. METHODS According to the characteristics of excipients, the dispersible tablets were prepared with crosslinked polyvinylpyrrolidone(PVPP) as disintegrating agent, microcrystalline cellulose as excipient, povidone K-30 as adhesive, magnesium stearate as lubricant and aspartame and lemon essence as flavoring agents. The prescription was screened through DOE design with the dispersion uniformity and dissolution as indicators. RESULTS The optimal prescription was screened as the active pharmaceutical ingredient particle size of (D90) was 15.0 μm, the proportions of PVPP and magnesium stearate were 45.0% and 0.6% respectively. CONCLUSION For the prepared sevelamer carbonate dispersible tablets, the formulation is reasonable, the process is feasible and the quality meets the requirement of the specification.