SPL Set ID: 3d02a4d4-d312-80b4-05c4-691b8f0aa7aa
1 drug(s) with this SPL Set ID
JENTADUETO XR tablets for oral use contain: linagliptin and metformin HCl. Linagliptin Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]- The molecular formula is C 25 H 28 N 8 O 2 and the molecular weight is 472.54 g/mol. The structural formula is: Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Chemical Structure Metformin HCl Metformin HCl ( N,N -dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C 4 H 11 N 5 ∙HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is: JENTADUETO XR consists of an extended-release metformin core tablet that is coated with the immediate-release drug substance linagliptin. JENTADUETO XR is available for oral administration as tablets containing: 5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin) 2.5 mg linagliptin and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin) Each coated tablet of JENTADUETO XR contains the following inactive ingredients: Tablet core: hypromellose, magnesium stearate, and polyethylene oxide. Coating: arginine, carnauba wax, ferric oxide yellow (2.5 mg/1,000 mg), ferrosoferric oxide, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, polyethylene glycol, propylene glycol, talc, and titanium dioxide. Chemical Structure