Abstract: The present disclosure provides floating gastroretentive compositions comprising a multilayer core comprising 1) a pull layer containing liothyronine or a pharmaceutically acceptable salt thereof, an acid, and a gas-generating agent; and 2) a push layer. Each of the pull layer and the push layer comprises a swellable water-soluble hydrophilic polymer. The composition further comprises a permeable elastic membrane covering at least a portion of the multilayer core and containing at least one orifice facing the pull layer. The permeable elastic membrane comprises a copolymer of ethyl acrylate, methyl methacrylate, and trimethylammonioethyl methacrylate chloride. The composition provides sustained release of liothyronine or a pharmaceutically acceptable salt thereof.
Type:
Application
Filed:
June 20, 2023
Publication date:
October 19, 2023
Applicant:
Amneal Complex Products Rearch LLC
Inventors:
Jaydeep Vaghashiya, Dipen Desai, Navnit H. Shah, Prajakta Bagul, Wantanee Phuapradit, Kanji Meghpara
Abstract: The present disclosure provides floating gastroretentive compositions comprising a multilayer core comprising 1) a pull layer containing liothyronine or a pharmaceutically acceptable salt thereof, an acid, and a gas-generating agent; and 2) a push layer. Each of the pull layer and the push layer comprises a swellable water-soluble hydrophilic polymer. 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 permeable elastic membrane comprises a copolymer of ethyl acrylate, methyl methacrylate, and trimethylammonioethyl methacrylate chloride. The composition provides sustained release of liothyronine or a pharmaceutically acceptable salt thereof.
Type:
Application
Filed:
June 9, 2021
Publication date:
June 23, 2022
Applicant:
Amneal Complex Products Rearch LLC
Inventors:
Jaydeep Vaghashiya, Dipen Desai, Navnit H. Shah