METHOD FOR PRODUCING MEDICAMENT INCLUDING BIOLOGICALLY ACTIVE PROTEIN, AND FINAL PRODUCT Russian patent published in 2018 - IPC A61K38/00 A61K47/26 A61K9/19 

FIELD: medicine.

SUBSTANCE: group of inventions relates to the field of technology for the preservation of biologically active proteins. Method for the preparation of a medicament comprising a biologically active protein comprises the steps of: providing an aqueous composition comprising a solvent, a biologically active protein and between 20 % by weight and 60 % by weight of non-polymeric sugar; freezing the composition to form at least one frozen substance comprising the solvent in a frozen form; placing frozen substance in the drying apparatus with being on the substrate, wherein the substrate includes one or more retention mechanisms that define one or more substrate boundaries, where as much as 30 % of the surface of the substance is in contact with one or more retention mechanisms; reducing the pressure in the dryer below atmospheric pressure; providing heating of the substance for the purpose of sublimation of the frozen solvent of the substance and obtaining a dried substance; where the biologically active protein is dispersed in a solid medium of non-polymeric sugar and wherein the substance is a spheroid that has a volume equal to or greater than 50 mcl. Also a product in the form of a substantially homogeneous freeze-dried substance is proposed having a volume between 50 and 1,000 mcl comprising a biologically active protein, where the substance is produced by the above method, and a medicament in the form of a substantially homogeneous freeze-dried substance having a volume between 50 and 1,000 mcl comprising a biologically active protein, wherein the protein is dispersed into a solid non-polymeric sugar medium, characterized in that the substance comprises between about 21 and 72 % w/v. of said sugar.

EFFECT: group of inventions ensures the preservation of biologically active proteins and the production of an easy-to-use final product that provides a wide range of applications.

19 cl, 8 tbl, 6 ex, 4 dwg