FIELD: chemistry; pharmaceutics.
SUBSTANCE: one object is a pharmaceutical composition containing 0.1 to 1.0 mg/ml of active ingredient 4-amino-N-[N2-[N-[N-[N-((R)-2-phenylpropyl)glycyl]-D-phenylalanyl]-D-leucyl]-D-lysyl]piperidine-4-carboxylic acid or a pharmaceutically acceptable salt thereof, and 1–150 mM buffer solution, which is an acetate buffer solution, wherein the pH of the pharmaceutical composition ranges from 2.0 to 6.0. Second object is a pharmaceutical composition containing from 0.1 to 1.0 mg/ml of said active ingredient and 1–150 mM acetic acid and sodium acetate buffer. Third object is a method of producing said pharmaceutical compositions. Fourth object is the use of said pharmaceutical compositions for preparing a drug for treating or preventing a disease or condition associated with a KOR (kappa-opioid receptor) receptor in mammals.
EFFECT: storage stability of a pharmaceutical composition containing 4-amino-N-[N2-[N-[N-[N-((R)-2-phenylpropyl)glycyl]-D-phenylalanyl]-D-leucyl]-D-lysyl]piperidine-4-carboxylic acid or its salt.
20 cl, 8 tbl, 10 ex
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