公开(公告)号：US11458104B1

公开(公告)日：2022-10-04

申请号：US16562224

申请日：2019-09-05

申请人： Mission Pharmacal Company

发明人： Jon Taylor ,  Stuart Smoot ,  Stuart Schoenherr ,  Paul Werchan

IPC分类号： A61K9/28 ,  A61K31/198 ,  A61K9/20

摘要： A solid pharmaceutical composition is provided that includes a core, an inner coating, and an outer coating. The core includes tiopronin as an active agent. Further, the inner coating, which includes a cellulose-based polymer, surrounds the core, and the outer coating, which includes an enteric polymer, surrounds the inner coating. As a result of the specific components of the solid pharmaceutical composition, the solid pharmaceutical composition exhibits a fed state Cmax of tiopronin that is at least 70% of a 12-hour fasted state Cmax of tiopronin after oral administration of the solid pharmaceutical composition when administered as a 300 milligram dose. As such, it is possible for the solid pharmaceutical composition to be administered orally with or without food (e.g., in a fed or fasted state) while still achieving a desired maximum plasma concentration of the tiopronin in a delayed release formulation.