Amneal Pharmaceuticals. has been granted a patent for an oral solid formulation containing levodopa. The formulation features a multiparticulate controlled release system with a muco-adhesive and enteric polymer coating, designed to enhance drug delivery without a decarboxylase inhibitor, containing 90 to 500 mg of levodopa. 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 July 2024 was 46%. Grant share is based on the ratio of number of grants to total number of patents.
Controlled release oral formulation of levodopa
The granted patent US12064521B2 describes a multiparticulate controlled release oral solid formulation designed to deliver levodopa, its esters, or salts effectively. The formulation consists of controlled release particles that include a core made of levodopa, which is free from decarboxylase inhibitors, and is encapsulated in a rate-controlling coating. This coating is made from polymers such as cellulose acetate or ethyl cellulose. Additionally, a mucoadhesive coating surrounds the rate-controlling layer, enhancing the formulation's retention in the gastrointestinal tract. The core can take the form of pellets, beads, or granules, with specific size and retention characteristics outlined in the claims. The formulation is designed to contain between 90 to 500 mg of levodopa.
Further claims detail the composition of the mucoadhesive coating, which may include cationic polymers like amino methacrylate copolymers, and additional polymers such as polycarbophil and chitosan. The patent also specifies that the controlled release component should release less than 20% of levodopa within the first two hours, while an immediate release component containing levodopa and carbidopa is included to ensure rapid therapeutic effects. The immediate release component is designed to release 75% to 100% of carbidopa within 30 minutes. Overall, the formulation aims to provide a controlled and effective delivery of levodopa, addressing the needs of patients requiring consistent therapeutic levels of the medication.
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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
