The active ingredient in PREVACID (lansoprazole) Delayed-Release Capsules, PREVACID (lansoprazole) for Delayed-Release Oral Suspension and PREVACID (lansoprazole) SoluTab Delayed-Release Orally Disintegrating Tablets is a substituted benzimidazole, 2-[[[ 3-methyl-4-( 2, 2, 2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369. 37.
Lansoprazole is a white to brownish-white odorless crystalline 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.
PREVACID is supplied in delayed-release capsules, in delayed-release orally disintegrating tablets for oral administration and in a packet for delayed-release oral suspension. The delayed-release capsules contain the active ingredient, lansoprazole, in the form of enteric-coated granules and are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule.
Each delayed-release capsule contains enteric-coated granules consisting of lansoprazole, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, colloidal silicon dioxide, magnesium carbonate, methacrylic acid copolymer, starch, talc, sugar sphere, sucrose, polyethylene glycol, polysorbate 80, and titanium dioxide. Components of the gelatin capsule include gelatin, titanium dioxide, D& C Red No. 28, FD& C Blue No. 1, FD& C Green No. 3*, and FD& C Red No. 40.
PREVACID for Delayed-Release Orally Disintegrating Tablets contain the active ingredient, lansoprazole in the form of enteric-coated microgranules. The tablets are available in 15 mg and 30 mg dosage strengths. Each tablet contains lansoprazole and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium carbonate, hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, mannitol, methacrylic acid, polyacrylate, polyethylene glycol, glyceryl monostearate, polysorbate 80, triethyl citrate, ferric oxide, citric acid, crospovidone, aspartame**, strawberry flavor and magnesium stearate.