COMPOSITE FORMULATION FOR ORAL ADMINISTRATION COMPRISING EZETIMIBE AND ROSUVASTATIN Russian patent published in 2019 - IPC A61K9/16 A61K9/20 A61K9/48 A61K31/505 A61K31/397 A61K47/38 A61P3/06 

FIELD: medicine; pharmaceuticals.

SUBSTANCE: invention relates to a solid composite formulation for oral administration comprising: ezetimibe granules-part including ezetimibe, wherein said ezetimibe having a particle size distribution wherein the average particle size d_(0.9) for the bottom 90 % is about 10 mcm or less; and a rosuvastatin mixture-part including rosuvastatin or a pharmaceutically acceptable salt thereof, and a weakly basic stabilizer selected from the group consisting of sodium hydrogen carbonate, potassium hydrogen carbonate, magnesium hydrogen carbonate, ammonium hydrogen carbonate, and any combinations thereof, in an amount of about 0.05 parts to about 0.5 parts by weight based on 1 part by weight of rosuvastatin, and to a method of preparing the composite formulation.

EFFECT: present invention provides a solid composite formulation for oral administration having improved stability and dissolution rates of active ingredients including ezetimibe and rosuvastatin or a pharmaceutically acceptable salt thereof.

11 cl, 10 dwg, 21 tbl, 16 ex