NAPROXEN DELAYED-RELEASE TABLETS
DESCRIPTION
Naproxen is a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (+)-6-Methoxy-a-methyl-2-naphthaleneacetic acid. Naproxen has the following structural formula.
Molecular Formula: C14H14O3
Molecular Weight: 230.26
Naproxen is practically odourless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.
Naproxen delayed-release tablets are enteric-coated tablets containing 375 mg or 500 mg of naproxen and croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains sodium hydroxide, methacrylic acid copolymer, talc, polyethylene glycol, titanium dioxide, simethicone emulsion and purified water. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4.
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