PRILOSEC® (OMEPRAZOLE)
DELAYED-RELEASE CAPSULES
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]-1Hbenzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is
C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:
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. Each delayedrelease
capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of entericcoated
granules with the following inactive ingredients: cellulose, disodium hydrogen
phosphate, hydroxypropyl cellulose, hypromellose, 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.
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