PHARMACEUTICAL COMPOSITION OF CYCLOBENZAPRINE AND ITS USE Russian patent published in 2023 - IPC A61K31/135 A61K9/20 A61P21/02 

FIELD: medicine.

SUBSTANCE: group of inventions relates to the field of medicine and discloses a pharmaceutical composition with a muscle relaxant effect in the form of a tablet, which includes the active substance Cyclobenzaprine hydrochloride in a therapeutically effective amount, croscarmellose sodium or a combination of croscarmellose sodium and colloidal silicon dioxide as a stabilizing agent and an excipient, while the particle size of Cyclobenzaprine hydrochloride is characterized by the following distribution — the lower limit of the particle size range that 90% of the particles of Cyclobenzaprine hydrochloride (d10) have is at least 1 µm, and d90 (size of 90% particles of Cyclobenzaprine hydrochloride) does not exceed 150 microns, the ingredients are contained in the following ratio, parts by weight: cyclobenzaprine hydrochloride — 1; stabilizing agent — 0.1–5.0; filler — 5.0–30.0; and the composition does not contain a calcium salt with phosphoric acid. The group of inventions also relates to a method for obtaining a composition and to the use of the composition.

EFFECT: technical result of the claimed group of inventions is the high therapeutic activity of the medicinal product based on Cyclobenzaprine, storage stability (at least 2 years without the use of inorganic phosphates), high values of the active substance release rate (at least 85 wt.% after 30 minutes).

13 cl, 2 tbl, 8 ex