FIELD: medicine; pharmaceutics.
SUBSTANCE: group of inventions relates to the field of pharmaceutics, namely to a pharmaceutical composition of a tricyclic compound of a dual PDE3/PDE4 inhibitor, a method for its preparation and use thereof, and more specifically to a pharmaceutical composition of a compound of formula (I) or a pharmaceutically acceptable salt thereof, a method for production and use thereof.
Pharmaceutical composition for preventing or treating a condition associated with PDE3 and/or PDE4, containing: a therapeutically effective amount of a compound of formula (I) or a pharmaceutically acceptable salt thereof and a surfactant, where said surfactant is a polyoxyethylene sorbitan fatty acid ester or a sorbitan fatty acid ester, and wherein the weight ratio of the compound of formula (I) or a pharmaceutically acceptable salt thereof to the surfactant is from 1:200 to 100:1, and the weight of the compound of formula (I) or a pharmaceutically acceptable salt thereof is given based on the compound of formula (I). Method of producing said composition, comprising mixing a surfactant, a compound of formula (I) or a pharmaceutically acceptable salt thereof and at least one selected from a group consisting of a metal chelating agent, a buffer agent, a diluent and an osmotic pressure regulator. Method for preventing or treating a condition associated with PDE3 and/or PDE4 in a mammal, comprising administering to the mammal a therapeutically effective amount of said composition. Use of said composition for preparing a drug for preventing or treating a condition associated with PDE3 and/or PDE4.
EFFECT: said group of inventions enables to obtain and use a stable pharmaceutical composition with an acceptable level of impurities, good dispersibility, suitable for effective delivery of inhalation products used to prevent or treat a condition associated with PDE3 and/or PDE4.
35 cl, 6 dwg, 9 tbl, 9 ex
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