LYOPHILISED FORMULATIONS OF BENDAMUSTINE HYDROCHLORIDE Russian patent published in 2019 - IPC A61K9/19 A61K31/41 A61K31/4184 A61K31/02 A61K47/00 A61P35/02 

FIELD: medicine; pharmaceuticals.

SUBSTANCE: group of inventions relates to the chemical and pharmaceutical industry and provides a method of obtaining a lyophilised drug and the bendamustine hydrochloride drug itself for the treatment of chronic lymphocytic leukemia and non-Hodgkin's lymphoma, lyophilised from an aqueous solution containing mannitol and free of organic solvents, where said bendamustine hydrochloride has a purity determined by HPLC analysis above 99 % and where the ratio of mannitol to bendamustine hydrochloride ranges from 4.25 to 0.545. Inventions also include a clear and colourless solution reconstituted with water for injection from said drug.

EFFECT: group of inventions enables to obtain a drug with minimal bendamustine decomposition, where the amount of impurities associated with the decomposition of the active substance will not exceed 1 %; wherein the addition of a smaller amount of mannitol compared with the prior art reduces the risk of cracking of vials as a result of uncontrolled crystallisation of mannitol.

10 cl, 8 dwg, 13 ex