HIGHLY CONCENTRATED IMMUNOGLOBULIN COMPOSITION FOR PHARMACEUTICAL USE Russian patent published in 2021 - IPC A61K9/00 A61K9/08 A61K47/18 A61K39/395 

FIELD: pharmaceuticals; medicine.

SUBSTANCE: present invention relates to a liquid composition for stabilizing immunoglobulins containing polyclonal immunoglobulins, a viscosity-modulating amino acid, and a stabilizing amino acid, wherein the viscosity-modulating amino acid is arginine, and the stabilizing amino acid is glycine, wherein the total concentration of the stabilizing amino acid and the modulating viscosity of the amino acid is in the range of 100-400 mM, and wherein the concentration of the stabilizing amino acid is in the range of 80-300 mM, wherein more than 90% of polyclonal immunoglobulins are in the form of monomers or dimers, and less than 5% are in the form of polymers, and where the concentration of immunoglobulin in the composition is higher than 160 g/l, and the pH is 5.5-5.9. The present invention also relates to the use of a liquid composition for the stabilization of immunoglobulins and to a method for making a liquid composition.

EFFECT: obtaining conformationally stable immunoglobulin preparations that are stable during long-term storage, as well as maintain the viscosity of drugs injected or injected as low as possible.

14 cl, 6 dwg, 7 ex, 11 tbl