STABILISED AMORPHOUS FORM OF AGOMELATINE, PROCESS FOR PREPARATION THEREOF AND PHARMACEUTICAL COMPOSITIONS CONTAINING SAME Russian patent published in 2018 - IPC A61K9/10 A61K31/85 A61K31/165 A61K47/32 A61K47/38 A61P25/00 

FIELD: medicine; pharmaceuticals.

SUBSTANCE: group of inventions relates to the pharmaceutical industry, in particular to the stabilised amorphous form of agomelatine and a method for its preparation. Agomelatine is dispersed in a matrix as follows: 30, 40 or 50 % by weight of agomelatine in poly(methacrylic acid-methyl methacrylate) in a 1:1 ratio, 30, 35, 40 or 50 % by weight of agomelatine in poly(methacrylic acid-ethyl acrylate) in a 1:1 ratio, 30, 35 or 40 % by weight of agomelatine in a vinylpyrrolidone-vinyl acetate copolymer, 30, 35 or 40 % by weight of agomelatine in a crosslinked polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol copolymer, 30 or 40 % by weight of agomelatine in polyvinyl acetate phthalate, 30 % by weight of agomelatine in a linear random copolymer of N-vinyl-2-pyrrolidone and vinyl acetate in a ratio of 60:40 or 30 % by weight of agomelatine in HPMC acetyl succinate. Also disclosed is a method for the preparation of a stabilised amorphous form of agomelatine and the use of a stabilised amorphous form of agomelatine for the treatment of disorders of the melatonergic system.

EFFECT: group of inventions provides a storage-stable amorphous form of agomelatine for the treatment of disorders of the melatonergic system.

8 cl, 7 dwg, 3 tbl, 44 ex