Intra-Cellular Therapies has developed a new patent for stable amorphous solid dispersions of ITI-007 tosylate salt, with stabilizing excipients like cellulose acetate phthalate. This innovation opens up possibilities for new pharmaceutical compositions. 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 January 2024 was 34%. Grant share is based on the ratio of number of grants to total number of patents.
Amorphous solid dispersion of iti-007 tosylate salt
The 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 including cellulose acetate phthalate, hydroxypropyl methyl cellulose acetate succinate, and polyvinyl acetate among others. The dispersion may also include an anti-oxidant like tocopherol or a surfactant, and is x-ray amorphous to ensure stability.
Furthermore, the patent covers the manufacturing method of the dispersion, involving 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 resulting dispersion can be used in a pharmaceutical composition with a pharmaceutically acceptable diluent or carrier, in forms like tablets, capsules for oral administration, or depot formulations for long-acting injectables (LAI). The composition's X-ray diffraction pattern is devoid of peaks characteristic of the excipient, ensuring the purity and stability of the dispersion for pharmaceutical applications.
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