FIELD: pharmaceuticals.
SUBSTANCE: group of inventions relates to the field of pharmaceuticals and relates to a dosage form for oral administration for immediate release of a therapeutically effective amount of 5-azacytidine. Said dosage form releases 5-azacytidine in the stomach after oral administration to the subject. The dosage form constitutes an immediate release form without an enteric coating and comprises a central part of a medicinal product, containing 5-azacytidine, and additionally comprises a coating of the central part of the medicinal product, produced by coating the central part of the medicinal product using a solvent including an aqueous solvent or a non-aqueous solvent. Also proposed are variants of said dosage form are presented, as well as a method for treating a subject with a disease associated with abnormal cell proliferation, including administration of said dosage form.
EFFECT: use of the group of inventions ensures immediate release of 5-azacytidine in the gastric environment and allows for a significant systemic exposure after oral administration.
68 cl, 20 dwg, 12 tbl, 12 ex
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Authors
Dates
2022-01-25—Published
2018-03-15—Filed