PARTICLES CONTAINING AMORPHOUS EMPAGLIFLOZIN, A METHOD FOR PREPARING THEM AND A MEDICINAL AGENT CONTAINING THEM Russian patent published in 2020 - IPC A61K9/14 A61K9/16 A61K31/351 A61K31/7048 A61K47/30 A61K47/32 A61P3/10 

FIELD: medicine; pharmaceuticals.

SUBSTANCE: group of inventions relates to pharmaceutical industry, namely: to particles of spherical shape; to a method for production thereof; to a drug preparation in a solid dosage form for treating or preventing type 2 diabetes mellitus, containing said particles and at least one pharmaceutically acceptable excipient. Disclosed particles have size of 1–100 mcm (defined with D (0.9)), contain amorphous empagliflozin and a pharmaceutically acceptable polymer selected from a homopolymer of polyvinylpyrrolidone and a copolymer of vinylpyrrolidone and vinyl acetate, and obtained by spray drying under certain conditions. According to the proposed method, empagliflozin is mixed with a polymer and a solvent, then obtained solution is dried by spraying at drying gas flow rate of 5–7 l/min, dissolved solid substances content of 15–40 mg/ml, using two-phase nozzle with diameter of 0.6–0.8 mm, at temperature of drying gas at inlet 90–110 °C, outlet temperature of 60–65 °C and rate of sprayed solution introduction is 5–7 ml/min.

EFFECT: group of inventions provides spherical particles with narrow size distribution and excellent physical properties for making solid dosage forms (flowability, tableting).

11 cl, 5 ex, 2 tbl, 6 dwg