Amneal Pharmaceuticals has been granted a patent for a floating gastroretentive composition that provides sustained release of liothyronine. The composition includes a multilayer core with specific components and a permeable elastic membrane. The innovative design ensures effective delivery of the drug. GlobalData’s report on Amneal Pharmaceuticals gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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According to GlobalData’s company profile on Amneal Pharmaceuticals, was a key innovation area identified from patents. Amneal Pharmaceuticals's grant share as of April 2024 was 47%. Grant share is based on the ratio of number of grants to total number of patents.

Patent granted for floating gastroretentive composition with sustained release

Source: United States Patent and Trademark Office (USPTO). Credit: Amneal Pharmaceuticals Inc

A recently granted patent (Publication Number: US11964048B2) discloses an innovative osmotic, floating, gastroretentive composition designed for the treatment of hypothyroidism. The composition comprises a multilayer core with a pull layer containing liothyronine or its salt, an acid, and a gas-generating agent, along with a push layer. The core is covered by a permeable, elastic membrane with at least one orifice, made of a specific copolymer and a plasticizer. Notably, the composition does not include a semipermeable membrane, ensuring its unique design for sustained release and maintaining plasma concentration of liothyronine within a therapeutic range for at least 6 hours.

The patent further details the specific components and ratios used in the composition, including the copolymer of the elastic membrane, plasticizer, acid, and swellable, water-soluble polymers in the layers. The method for making the composition involves creating a pull layer blend and a push layer blend, pressing them into a bilayered tablet core, coating it with the elastic membrane, and drilling orifices for controlled drug release. The method also includes the preparation of liothyronine granules using wet or dry granulation techniques. This patented composition and method offer a novel approach to treating hypothyroidism, providing a once-a-day administration option with sustained release properties, potentially improving patient compliance and therapeutic outcomes.

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GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies