S-NITROSOTHIOL STERILIZATION Russian patent published in 2021 - IPC A61L2/08 A61K41/00 A61K31/95 

FIELD: medicine; veterinary medicine.

SUBSTANCE: group of inventions relates to sterile S-nitrosothiols and sterile pharmaceutical precursors containing S-nitrosothiols, from which sterile pharmaceutical compositions can be prepared with one or more sterile pharmaceutical diluents, excipients, carriers, additional active agents or any combination thereof, if desired, for pharmaceutical or veterinary use. A method for producing sterile dry solid S-nitrosothiol with a degree of purity of S-nitrosothiol of at least approximately 95.0% and a sterility assured level (SAL) of 10-6 or lower involves exposing dry solid S-nitrosothiol to a sterilizing dose of ionizing radiation in an environment protected from external contamination, where the temperature of the dry solid during the sterilizing effect of ionizing radiation is maintained no higher than approximately 40°C. A method for obtaining a sterile dry solid precursor of a pharmaceutical composition, sterile dry solid S-nitrosothiol, a sterile dry solid precursor of a pharmaceutical composition, a method for obtaining a sterile pharmaceutical composition for use in humans or in veterinary medicine, a pharmaceutical composition containing S-nitrosothiol for the treatment or prevention of a condition, disease or disorder that respond to therapy with S-nitrosothiol or NO, a set for obtaining a pharmaceutical composition containing S-nitrosothiol are also disclosed.

EFFECT: group of inventions provides the preparation of sterile S-nitrosothiol with a degree of purity suitable for clinical use.

57 cl, 5 dwg, 4 tbl, 2 ex