FIELD: chemistry.
SUBSTANCE: group of inventions relates to vortioxetine pamoate powder for injections. Vortioxetine pamoate powder for injections consists of vortioxetine pamoate and pharmaceutically acceptable excipients; where pharmaceutically acceptable excipients include a suspending agent, where the suspending agent is sodium carboxymethyl cellulose, where the suspending agent is from 2.3 to 13.8 wt.%, preferably from 6.9 to 10.8 wt.%, of the total weight of the powder for injections, where pharmaceutically acceptable excipients additionally include mannitol as a lyoprotector and an osmotic pressure regulator, where mannitol is from 20.7 to 32.5 wt.% of the total weight of the powder for injections; and wherein the weight fraction of vortioxetine pamoate ranges from 54.0% to 72.4% in terms of the total weight of the powder for injections. Also disclosed is a method of producing vortioxetine pamoate powder for injections.
EFFECT: group of inventions provides stability of the composition with respect to particle sedimentation and delamination.
8 cl, 2 dwg, 5 ex
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