PHARMACEUTICAL COMPOSITION CONTAINING SOLID DISPERSIONS OF AMORPHOUS CLADRIBINE AND PHARMACEUTICALLY ACCEPTABLE WATER-SOLUBLE CARRIER Russian patent published in 2021 - IPC A61K31/7076 A61K9/10 A61K47/00 A61P35/00 

FIELD: medicine; pharmaceuticals.

SUBSTANCE: group of inventions relates to a pharmaceutical composition of cladribine. Cladribine pharmaceutical composition contains a solid dispersion of amorphous cladribine and a pharmaceutical acceptable water-soluble carrier, wherein the pharmaceutically acceptable water-soluble carrier used is maltodextrin spray dried maltodextrin from high amylose peas and wherein the weight ratio of cladribine and the pharmaceutically acceptable water-soluble carrier in the solid dispersion is not lower than 1:3. Also disclosed is a method of preparing the composition and a solid dispersion of amorphous cladribine and a pharmaceutically acceptable water-soluble carrier.

EFFECT: group of inventions provides high stability at low pH and high bioavailability of cladribine.

13 cl, 2 dwg, 1 tbl, 3 ex