EP4360705A3 — Sustained release compositions comprising liothyronine

USPTO Abstract

The present disclosure provides osmotic, floating gastroretentive compositions comprising a multilayer core comprising a pull layer containing liothyronine or a pharmaceutically acceptable salt thereof, an acid, a gas-generating agent, a first osmogen, and at least one water-soluble hydrophilic polymer; and a push layer comprising a polyethylene oxide polymer with an average molecular weight of at least 900,000 Da, and a second osmogen. The composition further comprises a permeable elastic membrane covering at least a portion of the multilayer core and containing at least one orifice in fluid communication with the pull layer. The composition provides sustained release, while maintaining plasma concentration of from 0.5 ng/ml to 3 ng/ml, of liothyronine or a pharmaceutically acceptable salt, for at least 6 hours.