PHARMACEUTICAL COMPOSITION COMPRISING A SOLID DISPERSION OF TADALAFIL Russian patent published in 2018 - IPC A61K31/4985 A61K47/32 A61K47/00 A61K9/10 A61K9/16 A61K9/20 

FIELD: medicine; pharmaceuticals.

SUBSTANCE: present invention relates to a pharmaceutical composition comprising a tadalafil solid dispersion and at least two different types of polymers: at least one cationic methacrylate copolymer and at least one anionic copolymer of methacrylic acid. Cationic methacrylate copolymer is obtained based on dimethylaminoethyl methacrylate-butyl methacrylate-methyl methacrylate in a ratio of 2:1:1. Anionic copolymer of methacrylic acid is obtained based on a methacrylic acid-ethyl acrylate copolymer in a ratio of 1:1. Also described is a method for preparing a composition by wet granulation. Composition according to the invention exhibits a tadalafil dissolution rate of at least 85 wt% for 20 minutes when tested in 1,000 ml of phosphate buffer (pH 6.8) + 0.35 wt% sodium dodecyl sulphate (SDS) in a USP apparatus II (peak vessels) at 50 rpm.

EFFECT: disclosed is a pharmaceutical composition comprising a solid dispersion of tadalafil.

20 cl, 2 dwg, 1 tbl, 1 ex