SOLID PREPARATIONS CONTAINING TOFOGLIFLOZIN, AND METHOD FOR PRODUCTION THEREOF Russian patent published in 2019 - IPC A61K31/7048 A61K9/20 A61K47/02 A61K47/10 A61K47/12 A61K47/14 A61K47/26 A61K47/32 A61K47/36 A61K47/38 A61J3/10 

FIELD: medicine; pharmaceuticals.

SUBSTANCE: present invention provides a method for preparing a pharmaceutical composition which is a tablet and contains a crystalline form of the tofogliflozin monohydrate as an active ingredient. Method involves mixing an auxiliary substance and a tofogliflozin monohydrate for preparing a powdered mixture and preparing the tablet from the powder mixture by direct pressing. Adjuvant contains filler, a disintegrating agent and a sliding agent. Crystalline form of tofogliflozin monohydrate includes crystalline form I, crystalline form II or mixture thereof. Composition practically does not contain calcium silicate. Preferably, the pharmaceutical composition, which is a tablet obtained using the described method, includes lactose hydrate, crystalline cellulose, sodium croscarmellose and hydrogenated oil and/or magnesium stearate as auxiliary components.

EFFECT: tofogliflozin monohydrate tablet obtained by direct pressing is characterized by improved disintegration and solubility properties.

10 cl, 4 dwg, 17 tbl, 12 ex