Prilosec

[Omeprazole]

Drug Description
DESCRIPTION

The active ingredient in PRILOSEC (omeprazole) Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[( 4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42.

Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155° C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. PRILOSEC is supplied as delayed-release capsules for oral administration.

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Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: cellulose, disodium hydrogen phosphate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose, mannitol, sodium lauryl sulfate and other ingredients. The capsule shells have the following inactive ingredients: gelatin-NF, FD& C Blue #1, FD& C Red #40, D& C Red #28, titanium dioxide, synthetic black iron oxide, isopropanol, butyl alcohol, FD& C Blue #2, D& C Red #7 Calcium Lake, and, in addition, the 10 mg and 40 mg capsule shells also contain D& C Yellow #10. 1