FIELD: chemistry; pharmaceutics.
SUBSTANCE: invention relates to chemical-pharmaceutical industry, namely, a pharmaceutical composition is disclosed in the form of a solid dispersion with analgesic activity, which contains a compound - methyl-2-(7-nitro-2-oxo-5-phenyl-3-propoxy-2,3-dihydro-1H-benzo[e][1,4]diazepin-1-yl)acetate of formula I in an effective amount and at least one pharmaceutically acceptable polymer selected from polymers and copolymers of vinylpyrrolidone, vinyl acetate and ethylene glycol. Also disclosed is a method of producing such a pharmaceutical composition by dissolving a compound of formula I and at least one pharmaceutically acceptable polymer in a solvent or a combination of solvents, followed by evaporation of the solvent from the obtained solution, as well as a method of producing a pharmaceutical composition, characterized in that the solid dispersion is obtained by hot melt extrusion at an extrusion temperature of 120 °C to 200 °C. I.
EFFECT: invention provides higher solubility of the compound of formula I in an aqueous solution and its bioavailability when administered orally.
8 cl, 2 tbl, 4 ex.
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Authors
Dates
2024-12-13—Published
2023-05-24—Filed