CONCENTRATE OF THERAPEUTIC SOLUTION Russian patent published in 2016 - IPC A61K31/25 B01F3/00 

FIELD: medicine.

SUBSTANCE: group deals with methods for stabilisation of active pharmaceutical ingredient in concentrated solution for oral introduction, which includes 42-52 wt % of water, 47-57 wt % of polyethyleneglycol, which has average molecular weight 3015-3685 Dalton; 0.05-0.36% of sodium benzoate and pharmaceutically acceptable acid. Described methods include stages, at which (a) quantity of pharmaceutically acceptable acid is corrected for pH value to be in the range 3.0-5.0 at temperature 25^oC; and (b) concentrated solution is packed into hermetic container, which has rate of oxygen penetration into dry container not higher than 0.1 cm³/container/day from air at pressure of one atmosphere (0.1 MPa) and temperature 25°C, measured in accordance with ASTM F-1307-02 standard; or (b) concentrated solution is packed into hermetic bottle, made of polymer resin, which has oxygen permeability higher than 100 cm³-mil/100 inch²atm-day (39.4 cm³·mm/m²-24 h-atm), being measured in form of film, or (B) concentrated solution is packed into hermetic container, made of polymer, which has oxygen permeability lower than 100 cm³-mil/100 inch²atm-day (39.4 cm³·mm/m²-24 h-atm),being measured in form of film.

EFFECT: obtaining concentrated polyethyleneglycol solution, which has good long storage stability, with minimised accumulation of degradation products.

41 cl, 8 ex, 8 tbl