STABLE ISOTONIC LYOPHILISED PROTEIN COMPOSITION Russian patent published in 2013 - IPC A61K9/19 A61K38/00 A61K39/00 A61K39/395 A61K47/26 

FIELD: medicine, pharmaceutics.

SUBSTANCE: group of inventions refers to medicine and pharmaceutics, and concerns a stable isotonic active composition containing protein in the amount of min. 50 mg/ml and a solvent which is used to dissolve the composition prepared of a lyophilised mixture of protein and a lyoprotectant, wherein the molar ratio of the lyoprotectant and protein in the mixture makes 100-600 moles of the lyoprotectant per 1 mole of the protein with the protein concentration in the dissolved active composition is 2-40 times higher than the protein concentration in the mixture before lyophilisation. What is also declared is a composition containing an antibody, particularly an anti-lgE-antibody or an anti-HER2-antibody, and a drug for treating mammals with some disorders characterised by HER2-receptor overexpression, particularly for treating cancer. The methods for preparing the composition involve the stages of lyophilisation of the mixture of the protein and lyoprotectant which is succhrose or trehaloes, dissolving the lyophilised mixture with a solvent to the protein concentration of min. 50 mg/ml.

EFFECT: group of inventions provides preparing the active composition stable at the high concentrations of the protein.

42 cl, 2 ex, 10 tbl, 19 dwg