Sidapvia Description

SIDAPVIA 10 mg/100 mg tablets are yellow, oval shaped, approximately 8 mm x 15 mm, biconvex, film-coated tablets with "F M" debossed on one side and plain on the other side.
Each film-coated tablet contains 10 mg dapagliflozin as dapagliflozin propanediol monohydrate and 100 mg sitagliptin as sitagliptin phosphate monohydrate.
Physicochemical Properties: Dapagliflozin: Chemical name: (1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-D-glucitol, (S)-propylene glycol, monohydrate.
Molecular formula: C₂₁H₂₅ClO₆·C₃H₈O₂·H₂O.
Molecular weight: 502.98.
Physicochemical characteristics: Dapagliflozin drug substance is a white to off-white powder, is non-hygroscopic, crystalline. Dapagliflozin is non-ionizable; thus, its aqueous solubility and partition coefficient are not affected by changes in pH.
Dapagliflozin is a Biopharmaceutical Classification System (BCS) Class III drug.
Sitagliptin: Chemical name: 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.
Molecular formula: C₁₆H₁₅F₆N₅O·H₃PO₄·H₂O.
Molecular weight: 523.32.
Physicochemical characteristics: Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. The pH of a saturated water solution of sitagliptin phosphate monohydrate is 4.4. The partition coefficient is 1.8, and the pKa is 7.7.
Excipients/Inactive Ingredients: Core tablet: croscarmellose sodium, crospovidone, microcrystalline cellulose, mannitol, magnesium stearate, calcium hydrogen phosphate, and sodium stearyl fumarate.
Film coating: polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, and iron oxide yellow.