SPL Set ID: 3f9699b5-7614-41cb-bd1d-ff02930e98f3

The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is 2-[( R )-[[3-methyl-4-(2,2,2-trifluoroethoxy)-2- pyridinyl]methyl]sulfinyl]-1 H -benzimidazole Sesquihydrate, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R -enantiomer of lansoprazole (a racemic mixture of the R - and S -enantiomers). Dexlansoprazole sesquihydrate’s molecular formula is: C 16 H 14 F 3 N 3 O 2 S•1½ H 2 O, with a molecular weight of 396.39. Dexlansoprazole sesquihydrate has the following chemical structure: Dexlansoprazole sesquihydrate is a white to brown color powder which melts with decomposition at 85.5°C. Dexlansoprazole sesquihydrate is freely soluble in N,N-dimethylformamide and practically insoluble in water. Dexlansoprazole sesquihydrate is not stable when exposed to light. Dexlansoprazole sesquihydrate is not stable in alkaline or acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole sesquihydrate in a single type of enteric-coated pellets [see Clinical Pharmacology (12.3) ] . Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated pellets consisting of dexlansoprazole sesquihydrate (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose dispersion type B, hypromellose, methacrylic acid - ethyl acrylate copolymer (1:1) type A, mono- and di-glycerides, polysorbate 80, potassium hydroxide, povidone, sucrose, sugar spheres (corn starch and sucrose), talc and triethyl citrate. The components of the capsule shells include the following inactive ingredients: carrageenan, FD&C Blue No. 2, hypromellose, potassium chloride and titanium dioxide. The black imprinting ink contains black iron oxide, potassium hydroxide and shellac. Dexlansoprazole Structural Formula