The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.
The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.
Patent No.:
Date of Patent:
Jan. 31, 2023
Filed:
Sep. 19, 2019
Kashiv Specialty Pharmaceuticals, Llc, Bridgewater, NJ (US);
Namdev B. Shelke, Hillsborough, NJ (US);
Siva Ram Kiran Vaka, Piscataway, NJ (US);
Navnit H. Shah, Monmouth Junction, NJ (US);
Dipen Desai, Whippany, NJ (US);
Wantanee Phuapradit, Montville, NJ (US);
Amneal Complex Products Research LLC, Bridgewater, NJ (US);
Abstract
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 extended release of trihexyphenidyl hydrochloride, with reduced C, and a C:Cratio of ≥0.4, while maintaining a therapeutically effective concentration for a period of 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. In certain embodiments, the compositions of the disclosure comprise an IR drug layer to provide extended release with a minimal lag time, while maintaining a therapeutically effective concentration of trihexyphenidyl hydrochloride for a period of at least about 16 hours.