Acantha Description

Sitagliptin (Acantha) tablets contain Sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5- trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C₁₆H₁₅F₆N₅O.H₃PO₄ and the molecular weight is 505.32.
Sitagliptin phosphate is a white to off-white powder. Each tablet of Sitagliptin (Acantha) contains 31.015, 62.031, or 124.061 mg of Sitagliptin phosphate, which is equivalent to 25, 50, or 100 mg, respectively, of free base.
Each tablet contains: Sitagliptin (as phosphate) 50 mg.
Each tablet contains: Sitagliptin (as phosphate) 100 mg.
Excipients/Inactive Ingredients: Microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, and sodium stearyl fumarate.
In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.