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DEXILANT delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and inactive ingredients.
The active ingredient in DEXILANT (dexlansoprazole) delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl}sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R-enantiomer of lansoprazole (a racemic mixture of the R- and S-enantiomers). Its empirical formula is C16H14F3N3O2S, with a molecular weight of 369.36.
Dexlansoprazole is a white to nearly white crystalline powder which melts with decomposition at 140°C. Dexlansoprazole is freely soluble in dimethylformamide, methanol, dichloromethane, ethanol, and ethyl acetate; soluble in acetonitrile; slightly soluble in ether; very slightly soluble in water; and practically insoluble in hexane.
Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions.
Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see Pharmacology: Pharmacokinetics under Actions].
Excipients/Inactive Ingredients: sugar spheres, magnesium carbonate, sucrose, low-substituted hydroxypropyl cellulose, titanium dioxide, hydroxypropyl cellulose, hypromellose 2910, talc, methacrylic acid and ethyl acrylate copolymers dispersion, type A methacrylic acid copolymer, type B methacrylic acid copolymer, polyethylene glycol 8000, triethyl citrate, polysorbate 80, colloidal silicon dioxide.
The components of the capsule shell include the following inactive ingredients: hypromellose, FD&C Blue No. 2 aluminum lake, red ferric oxide, yellow ferric oxide, carnauba wax, bleached shellac, glycerol mono-oleate.
