FIELD: medicine; pharmaceutics.
SUBSTANCE: group of inventions relates to a dosage form of botulinum toxin. Lyophilized composition of botulinum toxin containing a complex of botulinum toxin and protamine sulphate; from 5% to 20 (wt./vol.)% of hydroxypropyl-beta-cyclodextrin; from 0.35% to 0.5 (wt./vol.)% of human serum albumin; from 0.1% to 8 (wt./vol.)% of mannitol; from 0.7% to 0.95 (wt./vol.)% of an isotonic agent; buffer agent, where botulinum toxin and protamine sulphate form a complex in weight ratio from 1:5 to 1:20, where the buffer agent has pH of 6.0 to 7.0 and concentration of 10 to 35 mM. Also disclosed is a method of producing a lyophilised composition of botulinum toxin.
EFFECT: group of inventions provides higher stability of the lyophilised composition of botulinum toxin and increased homogeneity of the botulinum toxin particles in the composition.
5 cl, 5 tbl, 5 ex
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