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Lansoprazole
| DESCRIPTION |
| The active ingredient in lansoprazole delayed-release capsules is a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluroethoxy)-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 compound degrades in aqueous solution, the rate of degradation increasing with decreasing pH. At 25°C the t½ is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. |
| Prevacid is supplied in delayed-release capsules for oral administration. 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 (Prevacid 15 mg capsules only), and FD&C red no. 40. |