Intra-Cellular Therapies has been granted a patent for stable amorphous solid dispersions of ITI-007 tosylate salt, a potential pharmaceutical compound. The patent covers methods of production, use, and compositions containing stabilizing excipients like cellulose acetate phthalate and polyvinyl pyrrolidone. GlobalData’s report on Intra-Cellular Therapies 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 Intra-Cellular Therapies, Peptide pharmacophores was a key innovation area identified from patents. Intra-Cellular Therapies's grant share as of February 2024 was 52%. Grant share is based on the ratio of number of grants to total number of patents.

Patent granted for amorphous solid dispersion of iti-007 tosylate salt

Source: United States Patent and Trademark Office (USPTO). Credit: Intra-Cellular Therapies Inc

A recently granted patent (Publication Number: US11872223B2) discloses an amorphous solid dispersion containing 1-(4-fluoro-phenyl)-4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H,7H-pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxalin-8-yl)-butan-1-one (ITI-007) tosylate salt along with a stabilizing excipient. The stabilizing excipient can be selected from various options such as cellulose acetate phthalate, hydroxypropyl methyl cellulose acetate succinate, and polyvinyl acetate, among others. Additionally, the dispersion may include an anti-oxidant like tocopherol or a surfactant, and it is x-ray amorphous, ensuring a specific structure.

Moreover, the patent also covers a pharmaceutical composition incorporating the aforementioned dispersion along with a pharmaceutically acceptable diluent or carrier. This composition can be in the form of a tablet or capsule for oral administration, providing a convenient dosage form for patients. The manufacturing process involves dissolving ITI-007 tosylate salt and the stabilizing excipient in suitable solvents like dioxane, methanol, or their mixtures, followed by solvent removal to obtain the amorphous solid dispersion. The patent also extends to depot formulations suitable for long-acting injectable (LAI) use, expanding the potential applications of the disclosed technology in the pharmaceutical industry.

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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