Lipocine has been granted a patent for a stable pharmaceutical composition containing (17-ß)-3-Oxoandrost-4-en-17-yl tridecanoate and a pharmaceutically acceptable carrier. The composition is suitable for administration to humans and remains free of impurities when stored for at least 1 month at specific temperature and humidity conditions. GlobalData’s report on Lipocine 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 Lipocine, Nanoparticle drug conjugates was a key innovation area identified from patents. Lipocine's grant share as of September 2023 was 47%. Grant share is based on the ratio of number of grants to total number of patents.
Patent granted for stable pharmaceutical composition of (17-ß)-3-oxoandrost-4-en-17-yl tridecanoate
A recently granted patent (Publication Number: US11707467B2) discloses a stable pharmaceutical composition for the treatment of (17-ß)-hydroxy androst-4-en-3-one deficiency in human subjects. The composition comprises (17-ß)-3-Oxoandrost-4-en-17-yl tridecanoate and a pharmaceutically acceptable carrier. The carrier includes oleic acid, ascorbyl palmitate, polyoxyl 40 hydrogenated castor oil, and glyceryl palmitostearate.
One of the key features of this composition is its stability. When stored for at least 1 month at a temperature of no less than 25°C and a relative humidity of no less than 60%, the composition remains substantially free of (17-ß)-3-Oxoandrost-4-en-17-yl tridecanoate impurities. This ensures the integrity and effectiveness of the pharmaceutical product over an extended period.
The (17-ß)-3-Oxoandrost-4-en-17-yl tridecanoate in the composition has a maximum of 10% total impurities, which includes both known and unknown impurities. Additionally, the composition contains 10% or less of any single known impurity, specifically beta-hydroxy androst-4-en-3-one. The presence of impurities is minimized to maintain the purity and safety of the pharmaceutical product.
Furthermore, the composition comprises less than 50,000 parts per million (PPM) of organic solvent, ensuring that the product is free from excessive solvent content, which can be harmful to the human body.
In an alternative embodiment, the composition is stored at a higher temperature of no less than 40°C and a relative humidity of no less than 75%. Even under these more extreme storage conditions, the composition remains substantially free of (17-ß)-3-Oxoandrost-4-en-17-yl tridecanoate impurities.
The pharmaceutical composition is suitable for administration to male subjects, particularly those with hypogonadal conditions. By providing a stable and pure form of (17-ß)-hydroxy androst-4-en-3-one, this composition offers a promising solution for addressing hormonal deficiencies in male patients.
Overall, this granted patent presents a stable pharmaceutical composition that effectively delivers (17-ß)-hydroxy androst-4-en-3-one to human subjects in need. Its unique formulation and storage conditions ensure the purity, stability, and safety of the product, making it a valuable addition to the field of hormone replacement therapy.
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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
