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.
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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