Nesina Description

NESINA 25 mg (Tablets): Each tablet contains alogliptin benzoate 34 mg equivalent to alogliptin 25 mg.
NESINA 12.5 mg (Tablets): Each tablet contains alogliptin benzoate 17 mg equivalent to alogliptin 12.5 mg.
NESINA 6.25 mg (Tablets): Each tablet contains alogliptin benzoate 8.5 mg equivalent to alogliptin 6.25 mg.
NESINA tablets contain the active ingredient alogliptin, which is a selective, orally bioavailable inhibitor of the enzymatic activity of dipeptidyl peptidase-4 (DPP-4).
Chemically, alogliptin is prepared as a benzoate salt, which is identified as 2-({6-[(3R)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile monobenzoate. It has a molecular formula of C₁₈H₂₁N₅O₂•C₇H₆O₂ and a molecular weight of 461.51 daltons.
Alogliptin benzoate is a white to off-white crystalline powder containing one asymmetric carbon in the aminopiperidine moiety. It is soluble in dimethylsulfoxide, sparingly soluble in water and methanol, slightly soluble in ethanol, and very slightly soluble in octanol and isopropyl acetate.
Each NESINA tablet contains 34 mg, 17 mg or 8.5 mg alogliptin benzoate, which is equivalent to 25 mg, 12.5 mg or 6.25 mg, respectively, of alogliptin.
Excipients/Inactive Ingredients: Mannitol, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: Hypromellose, titanium dioxide, ferric oxide (red or yellow) and polyethylene glycol, and is marked with printing ink (Gray F1).