DILT-CD
(Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage) 120 mg, 180 mg, 240 mg and 300 mg
DESCRIPTION
Diltiazem hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)one,3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is:
Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, formic acid, methanol, and chloroform, sparingly soluble in dehydrated alcohol, and insoluble in ether. It has a molecular weight of 450.98. DILT-CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage) is formulated for oral administration as a once-a-day extended release capsule containing either 120 mg, 180 mg, 240 mg, or 300 mg diltiazem hydrochloride. In addition, each capsule also contains the following inactive ingredients: dibutyl phthalate, eudragit, methacrylic acid copolymer dispersion, methylcellulose, microcrystalline cellulose, polysorbate, talc, and triethyl citrate. Each capsule shell contains gelatin and titanium dioxide. The 180 mg and 240 mg capsule shells also contain FD&C blue #1; the 300 mg capsule shell also contains black iron oxide. The capsule imprinting ink contains ammonium hydroxide, black iron oxide, potassium hydroxide, propylene glycol and shellac.
USP Drug Release Test 3.
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