SPL Set ID: 20ff347c-ca18-497b-948d-1145035f2ffc
1 drug(s) with this SPL Set ID
The active ingredient in lansoprazole delayed-release orally disintegrating tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoro-ethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 16 H 14 F 3 N 3 O 2 S with a molecular weight of 369.37. Lansoprazole has the following structure: Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release orally disintegrating tablets for oral administration. Lansoprazole delayed-release orally disintegrating tablets are available in two dosage strengths: 15 and 30 mg of lansoprazole per tablet. Each delayed-release orally disintegrating tablet contains enteric-coated pellets consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: artificial strawberry flavor, aspartame 1 , citric acid monohydrate, crospovidone, hydroxypropyl cellulose, magnesium carbonate, magnesium stearate, mannitol, methacrylic acid copolymer type C, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium bicarbonate, sodium hydroxide, sodium lauryl sulfate, sodium starch glycolate (potato), sugar spheres (corn starch and sucrose), talc, triethyl citrate and yellow iron oxide. 1 Phenylketonurics: Lansoprazole delayed-release orally disintegrating tablets contain phenylalanine 3.37 mg per 15 mg tablet and 6.74 mg per 30 mg tablet. Lansoprazole Structural Formula