Flüssige Orale Pharmazeutische Suspensionsdarreichungsform von Eslicarbazepinacetat mit Sofortiger Freisetzung

Details

Veröffentlichungs-Nr.

EP4775200

Anmeldetag

17. Dezember 2025

Veröffentlichung

15. Juli 2026

Rechtsraum

EP

Abstract

An immediate-release liquid oral suspension of Eslicarbazepine Acetate, containing between about 5 to about 10 g of active ingredient per 100 mL, along with carbomer homopolymer and microcrystalline cellulose as viscosity modifying agents. It may further comprise, parabens as antimicrobial agent, sucralose as a sweetener, and polyethylene glycol 8 stearate as a surfactant. The suspension is designed to provide bioequivalence to marketed Eslicarbazepine Acetate tablets, ensuring rapid drug release and stability over extended storage periods. The pH is adjusted to 3.0-6.5 to maintain stability, with impurities remaining under 0.05% of the eslicarbazepine content after stress storage conditions. This formulation offers an alternative to solid dosage forms for patients with partial-onset seizures.

Anmelder

Firma

Saptalis Pharmaceuticals, LLC

Land

🇺🇸 USA