INJECTION PHARMACEUTICAL COMPOSITION COMPRISING TRABECTEDIN FOR USE OUTSIDE THE GASTROINTESTINAL TRACT AND A METHOD FOR PREPARING IT Russian patent published in 2020 - IPC A61K9/19 A61K31/4995 A61K47/10 A61K47/26 A61P35/00 

FIELD: pharmaceuticals.

SUBSTANCE: group of inventions refers to an injectable pharmaceutical composition containing trabectedin for use outside the gastrointestinal tract and a method for preparing it. Injectable parenteral pharmaceutical composition of trabectedin contains the first excipient and the second excipient. First excipient represents one or more substances selected from a group consisting of a monosaccharide and a polyol. Second excipient is one or more substances selected from a group, consisting of albumin, dextran, hydroxyethyl starch, sodium carboxymethyl cellulose, hydroxypropyl-beta-cyclodextrin, maltodextrin and polyethylene glycol. Injectable composition of trabectedin can be obtained by reconstitution of a lyophilized composition. Another embodiment is a method of producing said composition, involving the following steps: 1) trabectedin is dissolved in acidic buffer salt solution to obtain a buffer solution of trabectedin; 2) dissolving required first excipient and second excipient in buffer salt solution and bringing pH to preset value; 3) two solutions are thoroughly mixed from step 1) and step 2), and pH is then adjusted to a predetermined value.

EFFECT: use of group of inventions improves stability of composition.

17 cl, 2 dwg, 17 tbl, 10 ex