BI-LAYER TABLET COMPOSITION Russian patent published in 2016 - IPC A61K31/7034 A61K31/155 A61K31/403 A61K9/20 A61K9/24 A61K47/00 A61P3/10 A61P3/00 

FIELD: medicine.

SUBSTANCE: what is described is a bi-layer tablet containing in its first layer a composition of metformin hydrochloride, in its second layer - a composition of the SGLT2 inhibitor dapagliflozin or dapagliflozin propylene glycol hydrate, and optionally a coating film. The first layer composition contains 40-87% of metformin hydrochloride; 1-10% of sodium carboxy-methylcellulose; 10-45% of hydroxypropyl methylcellulose; 0.1-1.5% of magnesium stearate and 0-2% of silicon dioxide or 0-1.5% of colloidal dioxide of the total weight of the first layer. The second layer composition contains 0.5-4% of dapagliflozin or dapagliflozin propylene glycol hydrate (S); 50-80% of microcrystalline cellulose, 14-18% of anhydrous lactose, 0-20% of pregelatinised starch, 0-20% of mannitol, 0-15% of hydroxypropyl cellulose; 2-6% of crospovidone as a disintegrating agent; 0.5-2.5% of silicon dioxide and 0.5-2% of magnesium stearate of the total weight of the second layer.

EFFECT: reducing cracking, splitting and cross-contamination of the two layers of the bi-layer tablet, while maintaining the content of the active substance, and the uniformity of the second layer.

13 cl, 13 tbl, 15 ex