PREPARATIONS OF POLYALKYLENE OXIDE-ASPARAGINASE AND METHODS FOR THEIR PREPARATION AND APPLICATION Russian patent published in 2021 - IPC A61K9/19 C12N9/82 C12N9/96 

FIELD: medicine.

SUBSTANCE: invention relates to medicine; it can be used for the treatment of a tumor condition in a subject. A reduced lyophilized composition for deamination of asparagine is claimed, which contains polyalkylene oxide-asparaginase at a concentration from 100 to 5000 IU/ml of the specified composition, sodium dibasic phosphate at a concentration from 0.1 to 0.8 wt. % , monobasic sodium phosphate in a concentration from 0.01 to 0.5 wt. % , salt in a concentration from 0.05 to 1 wt. % and sugar in a concentration from 0.1 to 25 wt. %, where polyalkylene oxide-asparaginase contains asparaginase covalently bound to a polyalkylene oxide group. A lyophilized storage-stable composition for deamination of asparagine is stable during storage and is capable of forming a reduced lyophilized storage-stable composition, when reduced with water for injection (WFI). A method for preparing a lyophilized composition of polyalkylene oxide-asparaginase includes lyophilization of an aqueous concentrate of a composition containing: (I) polyalkylene oxide-asparaginase containing a polyalkylene oxide group covalently bound to asparaginase by a linker; (II) a buffer containing sodium dibasic phosphate and sodium monobasic phosphate; (III) salt and (III) sugar. An asparagine deamination kit contains one or more containers with single doses, each containing a lyophilized storage-stable composition.

EFFECT: compositions are used for various applications, for example, for the treatment of a tumor condition in a subject.

18 cl, 32 tbl, 16 dwg, 3 ex