Amneal Pharmaceuticals has been granted a patent for extended-release pyridostigmine dosage forms, including gastroretentive tablets with a unique copolymer membrane. These forms aim to maintain stable plasma concentrations with controlled drug release, improving patient compliance. The dosage form floats in 40 minutes or less in a specific dissolution medium. 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 February 2024 was 47%. Grant share is based on the ratio of number of grants to total number of patents.

Gastroretentive dosage form for extended release of pyridostigmine

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

A recently granted patent (Publication Number: US11911515B2) discloses a gastroretentive dosage form designed to float in a dissolution medium within 40 minutes. The dosage form comprises a core containing pyridostigmine or its salt, a gas generating agent, and a permeable elastic membrane made of a copolymer based on ethyl acrylate, methyl methacrylate, and trimethylammonioethyl methacrylate chloride. The gas generating agent, which includes carbonate and bicarbonate salts of alkali and alkaline earth metals, aids in the floating mechanism. Additionally, the core may contain an acid, a wicking agent, a glidant, and a swellable water-soluble hydrophilic polymer to enhance drug release and performance.

Furthermore, the patent describes variations of the gastroretentive dosage form, including different compositions and functionalities. For instance, some forms exhibit controlled release properties, providing therapeutic plasma concentrations of pyridostigmine for extended periods. These variations may include additional components such as acids, gas generating agents, and swellable water-soluble hydrophilic polymers to achieve specific drug release profiles. The patent highlights the use of specific copolymers in the permeable elastic membrane to ensure optimal performance and drug delivery. Overall, the patent showcases innovative formulations and design strategies for gastroretentive dosage forms, offering potential advancements in drug delivery technology.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

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