FIELD: chemistry.
SUBSTANCE: group of inventions relates to a solid composition of tofacitinib. Sustained release non-osmotic single-layer composition contains tofacitinib or a salt thereof; mixture of two or more polyethylene oxides; one or more pharmaceutically acceptable excipients selected from a group consisting of: a diluent, where the diluent is selected from a group consisting of lactose, microcrystalline cellulose, mannitol or a mixture thereof; binder, where binder is selected from the group consisting of povidone, hydroxypropyl cellulose or mixture thereof; solvent, where the solvent is selected from a group consisting of isopropyl alcohol, water or a mixture thereof; lubricant, where the lubricant is selected from magnesium stearate, where the molecular weight of the polyethylene oxide is in range of 800,000 g/mol to 3,000,000 g/mol, and where the composition contains a mixture of two polyethylene oxides in ratio of 1:0.1 to 1:10. Also disclosed is a method of producing a non-osmotic single-layer composition of sustained release.
EFFECT: group of inventions provides sustained release of tofacitinib.
8 cl, 9 tbl, 5 ex
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Authors
Dates
2025-04-29—Published
2021-05-17—Filed