碳酸镧咀嚼片体外磷结合试验的一般考虑

碳酸镧咀嚼片于2004年由美国FDA批准上市,作为一种磷结合剂用于降低终末期肾病患者血清磷酸盐.碳酸镧是胃肠道(GI)局部作用药物,口服吸收率非常低,不适合采用常规的体内药动学(PK)终点方法评价生物等效性.FDA认为,体外溶出试验和磷酸盐结合研究可用于证明碳酸镧生物等效性.本文在FDA个药指南和文献资料基础上,从方法...

Considerations on in vitro phosphate binding experiments for lanthanum carbonate chewable tablets

Lanthanum carbonate chewable tablets were approved as a phosphate binder indicated to reduce serum phosphate in patients with end stage renal disease by the US FDA in the year of 2004. Lanthanum carbonate is a gastrointestinal( GI) tract locally acting drug. The oral absorption of lanthanum carbonate is very low,so the conventional in vivo bioequivalence study with a pharmacokinetic( PK) endpoint is not feasible. The FDA recommended in vitro dissolution testing and phosphate binding studies to demonstrate bioequivalence of lanthanum carbonate preparations. Based on the literatures and guidance issued by FDA,this article discussed the in vitro phosphate binding research of lanthanum carbonate chewable tablets from the aspects of methodology,experimental design and data analysis,hoping to provide references for the development of the generic drugs.