BORTEZOMIB LYOPHILIZATE PRODUCTION METHOD AND THE BORTEZOMIB CONTAINING PHARMACEUTICAL COMPOSITION IN THE FORM OF STABLE LYOPHILIZATED PRODUCT PRODUCED BY SAID METHOD Russian patent published in 2018 - IPC A61K9/19 A61K38/05 A61K31/4965 A61K31/69 A61K47/26 A61K9/08 A61P35/00 

FIELD: technological processes.

SUBSTANCE: invention relates to the bortezomib lyophilizate (bortezomib substance) production process. Bortezomib lyophilizate is produced by successive production first of the mannitol aqueous solution with its concentration in the solution of 10–20 mg/ml; then the bortezomib aqueous solution production in the resulting mannitol aqueous solution with the bortezomib concentration of 1.0–2.5 mg/ml. Next, performing the product lyophilic drying in the freeze-drying chamber in several steps under certain temperature conditions, with the freeze drying steps certain duration. Producing the stable bortezomib lyophilizate with the product high purity of up to 99.85 wt.%. Also disclosed is the pharmaceutical composition containing, as an active ingredient, the freeze-dried bortezomib lyophilizate, and purified water or physiological saline as the pharmaceutically acceptable carriers.

EFFECT: process according to the invention enables production of the stable and highly purified target product – bortezomib lyophilizate, as well as ability to control all the process stages and their implementation conditions.

5 cl, 2 ex