Amneal Pharmaceuticals. has been granted a patent for a floating gastroretentive tablet dosage form designed to enhance gastric residence time. The formulation includes pyridostigmine bromide, a swellable polymer, and a gas-generating agent, coated with a permeable elastic membrane for controlled drug release. GlobalData’s report on Amneal Pharmaceuticals gives a 360-degree view of the company including its patenting strategy. Buy the report here.
According to GlobalData’s company profile on Amneal Pharmaceuticals, was a key innovation area identified from patents. Amneal Pharmaceuticals's grant share as of June 2024 was 46%. Grant share is based on the ratio of number of grants to total number of patents.
Gastroretentive tablet for targeted drug release
The granted patent US12042559B2 describes a gastroretentive tablet dosage form designed to enhance the bioavailability of drugs with a narrow absorption window in the proximal gastrointestinal (GI) tract. The core of the tablet comprises pyridostigmine bromide, a swellable water-soluble hydrophilic polymer, and a gas-generating agent. This core is enveloped by a water-insoluble permeable elastic membrane that features an orifice, which is formulated with a plasticizer and a specific copolymer. The patent outlines various formulations, including the selection of plasticizers such as triethyl citrate and polyethylene glycol, and specifies the proportions of these components to optimize the tablet's performance.
Additionally, the patent claims that the gastroretentive dosage form can provide extended release of pyridostigmine bromide for at least 12 hours, as measured in a specific buffer solution. The tablet core may also include various acids and superdisintegrants to further enhance its efficacy. The claims extend to a version of the dosage form that includes an immediate release layer surrounding the elastic membrane, which also contains pyridostigmine bromide. This innovative design aims to improve the therapeutic outcomes for patients requiring sustained drug delivery in the upper GI tract, addressing the challenges associated with drugs that have limited absorption capabilities.
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