saxagliptin - Generic Medications

Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1 S ,3 S ,5 S )-2-[(2 S )-2-Amino-2-(3-hydroxytricyclo[3.3.1.1 3,7 ]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1 S ,3 S ,5 S )-2-[(2 S )-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C 18 H 25 N 3 O 2 •H 2 O and the molecular weight is 333.43. The structural formula is: 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). 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 and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: iron oxides, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Saxagliptin Chemical Structure

Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1 S ,3 S ,5 S )-2-[(2 S )-2-Amino-2-(3- hydroxytricyclo[3.3.1.1 3,7 ]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1 S ,3 S ,5 S )-2-[(2 S )-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2- azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The molecular formula is C 18 H 25 N 3 O 2 •H 2 O and the molecular weight is 333.43. The structural formula is: Saxagliptin monohydrate is a white to off-white, 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). Each film-coated tablet of saxagliptin 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 and the following inactive ingredients: ascorbic acid, crospovidone, glyceryl monostearate, hydroxypropyl cellulose, iron oxide yellow, magnesium sterate, mannitol, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulphate, talc and titanium dioxide. In addition, the 2.5 mg tablets contain FD&C yellow#5/Tartrazine aluminium lake and iron oxide black. The 5 mg tablets contain FD&C yellow#6/Sunset yellow FCF aluminium lake and iron oxide red. Saxagliptin Monohydrate Chemical Structure

Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin hydrochloride dihydrate is described chemically as (1S,3S,5S)-2-[(2S)-Amino-(3-hydroxytricyclo [3.3.1.1 3,7 ]dec-1-yl)acetyl]-2-azabicyclo[3.1.0] hexane-3-carbonitrile hydrochloride dihydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo [3.1.0] hexane-3-carbonitrile hydrochloride dihydrate. The empirical formula is C 18 H 25 N 3 O 2 •HCl•2H 2 O and the molecular weight is 387.92. The structural formula is: Saxagliptin hydrochloride dihydrate is a white to off-white, 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). Each film-coated tablet of saxagliptin for oral use contains either 3.075 mg saxagliptin hydrochloride dihydrate equivalent to 2.5 mg saxagliptin or 6.149 mg saxagliptin hydrochloride dihydrate equivalent to 5 mg saxagliptin and the following inactive ingredients: croscarmellose sodium, hydrochloric acid, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium hydroxide, talc and titanium dioxide. The 2.5 mg tablets also contain yellow iron oxide. The imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. Saxagliptin Hydrochloride Structural Formula

Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1 S ,3 S ,5 S )-2-[(2 S )-2-Amino-2-(3-hydroxytricyclo[3.3.1.1 3,7 ]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1 S ,3 S ,5 S )-2-[(2 S )-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C 18 H 25 N 3 O 2 •H 2 O and the molecular weight is 333.43. The structural formula is: Saxagliptin monohydrate is a white to off-white powder. It is soluble in methanol, ethanol; sparingly soluble in water. Each film-coated tablet of saxagliptin for oral use contains either 2.79 mg saxagliptin hydrochloride equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride equivalent to 5 mg saxagliptin and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: hypromellose, iron oxide yellow (2.5 mg tablet only), iron oxide red (5 mg tablet only), polyethylene glycol and titanium dioxide. The imprinting ink contains the following: ammonium hydroxide, n-butyl alcohol, FD&C blue #2, isopropyl alcohol, propylene glycol and shellac. saxagliptistructure