Patent ID: 11458104

Abstract:
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.