FIELD: pharmaceutics; medicine.
SUBSTANCE: object 1 is a pharmaceutical composition for the treatment of a disease or a condition related to SOST, containing from 80 to 100 mg/ml of an antibody to SOST (a gene encoding protein sclerostin), from 10 to 30 mM of an acetate buffer, from 45 to 95 mg/ml of trehalose or sucrose, from 0.3 to 0.6 mg/ml of polysorbate 80, from 4.5 to 20 mM of calcium salt, pH is from 5.0 to 5.5. Objects 2 and 3 are a production method a lyophilized preparation containing an antibody to SOST. Objects 4 and 5 are a production method and a reduced solution containing an antibody to SOST. Objects 6 and 7 are the use of a pharmaceutical composition, or a lyophilized preparation, or a reduced solution in the manufacture of a drug for the treatment of a disease or a condition selected from osteoporosis, osteopenia or osteoarthritis, rheumatoid arthritis, periodontal disease, and multiple myeloma, and a method for the treatment of a disease or a condition. Object 8 is a container for the treatment of a disease or a condition related to SOST.
EFFECT: stability during storage of pharmaceutical compositions and preparations containing an antibody to SOST.
39 cl, 11 tbl, 9 ex
Authors
Dates
2022-09-07—Published
2018-07-26—Filed