Each film-coated tablet of ONGLYZA for oral use contains either 2.79 mg saxagliptin hydrochloride (anhydrous) equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin.
Saxagliptin is an orally-active inhibitor of the DPP4 enzyme.
Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2- [(2S)-2-Amino-2-(3-hydroxytricyclo [22.214.171.124,7] dec-1-yl) acetyl] -2-azabicyclo [3.1.0] hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2- [(2S)-2-Amino 2-(3-hydroxyadamantan-1-yl) acetyl] -2-azabicyclo [3.1.0] hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2·H2O and the molecular weight is 333.43.
Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropyl alcohol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400).
ONGLYZA (saxagliptin) tablets have markings on both sides and are available in the strengths and packages listed in Table 1. (See Table 1.)
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Excipients/Inactive Ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, and iron oxides.