JARDIANCE film-coated tablets contain 10 mg or 25 mg empagliflozin.
Physicochemical properties: Chemical Structure: Empagliflozin is a white to yellowish powder. It is very slightly soluble in water, slightly soluble in acetonitrile and ethanol, sparingly soluble in methanol and practically insoluble in toluene. Empagliflozin is not hygroscopic and no polymorphism has been observed. It is neither a hydrate nor a solvate. Partition coefficient: log P = log D (pH 7.4): 1.7.
Chemical name: (1S)-1,5-anhydro-1-(4-chloro-3-{4-[(3S)-tetrahydrofuran-3-yloxy]benzyl}phenyl)-D-glucitol.
Molecular formula: C23H27ClO7.
Molecular weight: 450.91.
CAS number: 864070-44-0.
Excipients with known effect: The JARDIANCE 10 mg and 25 mg tablets contain 162.5 mg and 113 mg of lactose monohydrate per tablet, respectively.
Excipients/Inactive Ingredients: Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide, purified talc, macrogol 400, iron oxide yellow.