INPEFA Tablet Ref.[107315] Active ingredients: Sotagliflozin

INPEFA tablets for oral administration contain sotagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor.

The chemical name of sotagliflozin is (2S,3R,4R,5S,6R)2(4-chloro-3-(4-ethoxybenzyl)phenyl)6(methylthio)tetrahydro-2H-pyran-3,4,5-triol.

Its molecular formula is C₂₁H₂₅ClO₅S and the molecular weight is 424.94.

The structural formula is:

Sotagliflozin is a white to off-white solid. It is practically insoluble in water.

Each film-coated tablet of INPEFA contains 200 mg or 400 mg of sotagliflozin and the following inactive ingredients. The core of the tablet contains colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and talc. The film coating for the 200 mg tablet contains: indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol (partly hydrolyzed), talc, and titanium dioxide. The film coating for the 400 mg tablet contains: hypromellose, lactose monohydrate, titanium dioxide, triacetin, and yellow iron oxide.