METHOD OF PRODUCING A STABLE, READY-TO-USE INFUSION BAG FOR AN OXIDATION-SENSITIVE COMPOSITION Russian patent published in 2020 - IPC A61J1/10 A61L2/07 A61K31/167 

FIELD: pharmaceuticals.

SUBSTANCE: group of inventions relates to production of pharmaceutical products. Disclosed is a method of producing a pharmaceutically acceptable product comprising acetaminophen, which can be sterilized in wet heat conditions in a container sterilized under wet heat conditions, said method comprising sterilizing a drug solution, containing acetaminophen dissolved in water. Said drug solution is contained in container sterilized under conditions of moist heat, wherein said sterilization under wet heat conditions is carried out at excess air pressure from 0.2 bar to 1.2 bar (0.02–0.12 MPa), to obtain a parenteral dosage form with a degradation degree of less than 0.1 % by weight of said amount of said acetaminophen, wherein said container sterilized under wet heat conditions is a flexible infusion bag made of plastic material, wherein said container sterilized under wet heat conditions is contained inside one or more coating covers and said one or more coating covers include one or more oxygen scavengers and moisture absorbers, and wherein water is not deoxygenated, and protective nitrogen atmosphere is not used during composition or storage of composition in ambient conditions in polymer bag before autoclaving. Also disclosed is a parenteral dosage form and a method of producing a stable, ready-to-use parenteral dosage form.

EFFECT: group of inventions provides a stable, ready-to-use oxidation-sensitive dosage form in a flexible infusion bag, without using an inert gas during or after production of the composition, or without introduction of an inert gas into the composition.

15 cl, 7 tbl, 4 ex