专利名称 | PARTICLES CONTAINING AMORPHOUS EMPAGLIFLOZIN, A METHOD FOR PREPARING THEM AND A MEDICINAL AGENT CONTAINING THEM | ||
申请号 | RU2019110795 | 申请日 | |
公开(公告)号 | RU2713428C1 | 公开(公告)日 | |
申请(专利权)人 | Зентива к с; Zentiva k s | 发明人 | КОВАЛЬЧИК Павел; КОВАЛЬЧИК ПавелKOVALCHIK Pavel |
专利来源 | 国家知识产权局 | 转化方式 | |
摘要 |
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 |
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