Formulations of apremilast

US11969409B2 · kind B2 · utility

Assignee

• AMGEN INC. · US

Inventors

• Nathan Bennette · Thousand Oaks, US
• William Brett Caldwell · Thousand Oaks, US
• Christi Hostetler · Bend, US
• Kazden Ingram · Thousand Oaks, US
• Dory King · Thousand Oaks, US
• Kyle Kyburz · Thousand Oaks, US
• Alison Viles · Thousand Oaks, US

Key dates

• Filing date: May 12, 2023
• Grant date: Apr 30, 2024
• Expiry date: May 12, 2043

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61K9/2866
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

Provided herein are oral dosage forms comprising a) a core tablet comprising (i) a drug layer comprising apremilast and hypromellose acetate succinate (HPMCAS) in an amorphous solid dispersion; and (ii) a swellable layer comprising one or more swellable polymers; and b) a coating layer disposed on the core tablet, wherein the oral dosage form surface comprises at least one drug release orifice. The disclosed oral dosage forms provide once-a-day dosing of apremilast and are suitable for treating diseases or disorders ameliorated by inhibiting phosphodiesterase subtype IV (PDE4).