Namdev B. Shelke,Siva Ram Kiran- Vaka,Navnit H. Shah,Dipen Desai,Wantanee Phuapradit
申请号：
US16864638
公开号：
US20200261372A1
申请日:
2020.05.01
申请国别(地区):
US
年份:
2020
代理人:
摘要：
The present disclosure provides extended release trihexyphenidyl compositions suitable for once- or twice-daily administration. The compositions comprise a core comprising organic acid that is coated with at least one drug layer comprising trihexyphenidyl hydrochloride, and a functional coat over the drug-layered core. The extended release compositions of the disclosure provide reduced Cmax, a Cmin:Cmax ratio of ≥；0.4, and extended release, while maintaining therapeutically effective concentration, of trihexyphenidyl for at least about 16 hours. The compositions of the disclosure improve solubility of trihexyphenidyl hydrochloride, at a pH of greater than or equal to 5, to maintain its minimum effective concentration at such pH.
