PROCESS FOR REDUCTION IN ENDOTOXIN CONTENT IN GELATIN Russian patent published in 2023 - IPC A61K47/42 A61K9/00 A61K9/19 

FIELD: pharmaceutical industry.

SUBSTANCE: group of inventions relates to the pharmaceutical industry, namely to a method for reduction in an endotoxin level in gelatin, as well as production of gelatin with a low endotoxin content, and its use. The method for reduction in an endotoxin level in gelatin includes: dissolution of salt in a gelatin solution containing gelatin and a solvent to form a gelatin-salt solution, wherein an endotoxin content in gelatin is at least 6000 EU/g, and a salt concentration in the gelatin-salt solution is 125-300 mM, and salt is sodium chloride; filtration of the gelatin-salt solution by means of an anion-exchange adsorber, as a result of which the endotoxin content in filtrate of the gelatin-salt solution is less than 2500 EU/g; and desalination of filtrate of the gelatin-salt solution to form a gelatin solution with a low endotoxin content, wherein the endotoxin content is less than 2500 EU/g. A gelatin solution with a low endotoxin content is also described. A method for the production of a lyophilized tablet for delivery of a pharmaceutically active ingredient is described. A lyophilized tablet for delivery of a pharmaceutically active ingredient is also described.

EFFECT: reduction in an endotoxin level in gelatin.

21 cl, 11 dwg, 6 tbl, 4 ex