NEW COMPOSITION OF LAPATINIB AS A SOLID DOSAGE FORM FOR ORAL USE AND A METHOD OF ITS MANUFACTURE Russian patent published in 2024 - IPC A61K31/517 A61K9/20 A61P35/00 

FIELD: pharmaceutical industry.

SUBSTANCE: invention relates to the composition of lapatinib as an oral solid dosage form. A pharmaceutical composition of lapatinib as an oral solid dosage form that comprises lapatinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients selected from diluents/fillers that are lactose monohydrate, mannitol, Soluplus® polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, lactose Flowlac® 100, Pharmaburst® 500, dicalcium phosphate, hydroxylpropyl methylcellulose, disintegrant, which is croscarmellose sodium, binder, which is povidone K30, lubricant, which is magnesium stearate, coating agents, but not limited to, while the composition does not contain any excipients including microcrystalline cellulose and sodium starch glycolate, where the composition includes: 25–50 wt./wt.% lapatinib or its pharmaceutically acceptable salt, 35–50 wt./wt%. diluent/filler, 2–10% wt./wt. binder, 2–10% wt./wt. baking powder, 0.25–1.5% wt./wt. lubricant, 2–4% wt./wt. coatings, purified water as needed.

EFFECT: above composition shows the desired dissolution profile and higher stability with minimal use of excipients, and also has fewer side effects.

4 cl, 1 dwg, 11 tbl, 9 ex