FIELD: medicine.
SUBSTANCE: group of inventions discloses a ready-to-use pharmaceutical composition in the form of an aqueous solution for sublingual and buccal administration, the said composition containing: 0.0075 wt./vol.% buprenorphine hydrochloride based on the base, 1.5 wt./vol.% about. hydroxyethylcellulose or 6.0 wt./vol.% sodium carboxymethyl cellulose, 0.12 wt./vol.% anhydrous citric acid, 1.13 wt./vol.% anhydrous sodium citrate, water for injection. The group of inventions also relates to a method for preparing a composition ready for use, to a syringe pre-filled with the composition, and to a package containing the composition.
EFFECT: safety and effectiveness of the composition for sublingual administration to newborns, which has a sufficient shelf life for storage and use. However, the composition has sufficient viscosity to hold it under the tongue of a newborn or an individual in need of treatment, and in close contact with the mucous membrane, avoiding ingestion and absorption through the gastrointestinal tract.
12 cl, 5 tbl, 2 dwg, 5 ex
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Authors
Dates
2023-04-28—Published
2018-10-17—Filed