Premier. has been granted a patent for stable parenteral compositions of phytonadione, featuring at least 97% of the (E) isomer and minimal (Z) isomer content. These formulations are designed to be sterile, particulate-free, and free of benzyl alcohol, reducing allergic reactions associated with certain excipients. GlobalData’s report on Premier 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 Premier, was a key innovation area identified from patents. Premier's grant share as of July 2024 was 60%. Grant share is based on the ratio of number of grants to total number of patents.

The granted patent US12070439B2 outlines a pharmaceutical composition primarily featuring phytonadione, specifically in its (E) isomer form, with a concentration ranging from 0.5 mg/ml to 10 mg/ml. The composition is characterized by a pH level between 3.5 and 8.0 and is designed to be substantially free of its (Z) isomer, which is limited to 3% w/w or less of the (E) isomer. Additionally, the formulation excludes benzyl alcohol and may include a pH adjuster, polysorbate in a specified ratio, and is free from other additives such as cremophor, propylene glycol, preservatives, antioxidants, and chelating agents. The composition is intended to be stored in non-reacting glass or polymeric containers, such as vials or pre-filled syringes, made from materials like polyethylene or polypropylene.

The patent also describes methods for administering the composition to mammals, including humans, with a focus on reducing the risk of anaphylactic reactions associated with phytonadione. Administration routes include intramuscular and subcutaneous methods. Furthermore, the patent details a manufacturing process for the composition, emphasizing the importance of filling the containers under vacuum or inert gas conditions to minimize oxygen exposure, ensuring that the headspace oxygen remains below 5%. This careful formulation and packaging aim to enhance the safety and efficacy of phytonadione administration in clinical settings.

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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