FIELD: medicine; pharmaceutics.
SUBSTANCE: group of inventions relates to pharmaceutical preparations containing an antibody-drug conjugate, and use thereof as an anticancer drug. Disclosed are pharmaceutical compositions for the treatment of cancer associated with the expression of HER2, containing from 10 mg/ml to 30 mg/ml of an antibody-drug conjugate of the following structure:
where n is a decimal or integer from 1 to 10, polysorbate 80 at concentration of 0.05 mg/ml to 0.5 mg/ml, sucrose at concentration of 60 mg/ml to 90 mg/ml and succinic acid-sodium succinate buffer at concentration of 5 mM to 20 mM. Pharmaceutical compositions have pH from 4.5 to 5.2. Invention also discloses a method of producing a lyophilised preparation and a method of treating cancer associated with expression of HER2.
EFFECT: invention enables to obtain a stable conjugate preparation in which there are no significant changes during storage at temperatures of 2–8 °C and 25 °C for at least 3 months.
12 cl, 8 dwg, 16 tbl, 69 ex
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|---|---|---|---|
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