Shilpa Medicare has been granted a patent for a stable oral liquid pharmaceutical composition containing vigabatrin, along with various excipients. The formulation maintains low impurity levels and is effective for up to three months at room temperature, with a pH range of 5 to 8. GlobalData’s report on Shilpa Medicare 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 Shilpa Medicare, Nanoparticle drug conjugates was a key innovation area identified from patents. Shilpa Medicare's grant share as of June 2024 was 21%. Grant share is based on the ratio of number of grants to total number of patents.
The granted patent US12016857B2 outlines a liquid pharmaceutical composition primarily containing vigabatrin, or its pharmaceutically acceptable salts, in concentrations ranging from 0.1 wt % to 20 wt %. The composition is designed to include various additional components such as preservatives, buffering agents, sweeteners, flavoring agents, and optional excipients like solubilizers, antioxidants, and coloring agents. Notably, the formulation is stable for up to three months at room temperature, maintaining total impurities below 0.06% during this period. The claims specify that the composition can be free of polyhydric alcohols with 2 to 6 carbon atoms, ensuring a tailored formulation for therapeutic efficacy.
Further claims detail specific ranges and types of ingredients, including a preferred vigabatrin concentration of 5 wt % to 15 wt %. The patent identifies methyl 4-hydroxy benzoate and propyl 4-hydroxy benzoate as suitable preservatives, while sweeteners like maltitol and sucralose are also specified. Flavoring agents can include a wide variety of natural and synthetic options, with particular emphasis on citrus and fruit essences. The composition is characterized by a pH range of 5 to 8, ensuring compatibility with various delivery methods. Overall, the patent presents a comprehensive formulation aimed at enhancing the stability and palatability of vigabatrin in liquid form, catering to patient needs in pharmaceutical applications.
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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
