| abstract |
FIELD: medicine, pharmacy. SUBSTANCE: invention relates to a stable isotonic composition comprising protein and suitable solvent diluting the lyophilized mixture of protein and lyoprotecting agent. The composition is used for preparing active composition with high protein concentration being without significant loss of protein stability. The concentration of protein in the composition is at least 50 mg/ml. The mole ratio of lyoprotecting agent to protein in the lyophilized mixture = (100-600):1, respectively. The protein concentration in the diluted active composition is by 20-40-fold higher as compared with the protein concentration in mixture before lyophilization. Compositions comprise, for example, anti-IgG and anti-HER2 antibody and there are prepared by lyophilization of these antibodies in the presence of lyoprotecting agent. Sucrose or trehalose is used as a lyoprotecting agent. The composition is a component of a medicinal agent for subcutaneous administration used in treatment of mammals with disturbances characterizing with superexpression of HR2 receptor, among the, cancer. The lyophilized protein composition is stable in storage and administration. EFFECT: valuable biological and medicinal properties of composition. 47 cl, 19 dwg, 10 tbl, 2 ex |