PHARMACEUTICAL COMPOSITION AND ITS ADMINISTERING Russian patent published in 2023 - IPC A61K31/47 A61K47/02 A61K47/26 A61K47/32 A61K47/38 A61P11/00 

FIELD: medicine.

SUBSTANCE: claimed group of inventions discloses a pharmaceutical composition for the treatment of cystic fibrosis in pediatric patients in a single dosage form, including one or a plurality of granules or mini-tablets, where the composition contains the following: (a) a solid dispersion in an amount of 30 to 40 wt.% by weight of the composition, where the dispersion contains the following: (i) 80 wt.% essentially amorphous or amorphous N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro- 4-oxoquinoline-3-carboxamide (Compound 1) by weight dispersion, (ii) 19.5 wt% hydroxypropyl methylcellulose acetate succinate (HPMCAS) by weight dispersion and (iii) 0.5 wt% sodium lauryl sulfate (SLS) by weight dispersion; (b) a two-component filler containing mannitol and lactose in a ratio of 1:3 mannitol to lactose; (c) a sweetener which is sucralose; (d) a disintegrant; (e) sliding agent; and (f) a lubricant; where the unit dosage form contains from 1 to 250 mg essentially amorphous or amorphous Compound 1 and where essentially amorphous Compound 1 has less than 15% crystallinity. The group of inventions also relates to a method of treating or reducing the severity of cystic fibrosis in a pediatric patient.

EFFECT: increasing the palatability of the pharmaceutical composition, improvement of the technological properties while maintaining the required bioavailability.

27 cl, 22 tbl, 2 dwg, 22 ex