FIELD: medicine; pharmaceutics.
SUBSTANCE: object 1 is a pharmaceutical composition containing (a) a compound of formula , or a pharmaceutically acceptable salt thereof, and (b) a pharmaceutically acceptable excipient, where the pharmaceutically acceptable excipient is mannitol, sorbitol, sucrose, lactose or trehalose, where the composition has a pH value equal to approximately pH 2 - pH 5.5 and the weight ratio of the compound and the pharmaceutically acceptable excipient is approximately from 1:1 to 1:9. Object 2 is lyophilized pharmaceutical composition containing (a) said compound or its pharmaceutically acceptable salt and (b) mannitol, wherein the weight ratio of the compound to mannitol is from about 1:1.3 to 1:3.8, and the pH of the pharmaceutical composition has a value of about 4.5 after reconstitution with normal saline to concentration of 10 to 20 mg/ml.
EFFECT: stability of the pharmaceutical composition.
14 cl, 1 dwg, 12 tbl, 6 ex
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Authors
Dates
2024-09-02—Published
2020-09-24—Filed