SPL Set ID: 325acf27-4b2e-40e8-8344-bb6cc9959910

Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4- (2-nitrophenyl)-, dimethyl ester, C 17 H 18 N 2 O 6 , and has the structural formula: Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets are formulated as a once-a-day controlled-release tablet for oral administration designed to deliver 30, 60, or 90 mg of nifedipine. Inert ingredients in the nifedipine extended-release tablet formulation are lactose monohydrate, microcrystalline cellulose, hypromellose, hydroxyethyl cellulose, ethylcellulose, sodium lauryl sulfate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, polyethylene glycol, talc, polyvinyl alcohol, titanium dioxide(30mg and 60mg), iron oxide yellow, iron oxide red, lecithin (soya) (30 mg and 90 mg), iron oxide black (30 mg and 90 mg). System Components and Performance Nifedipine extended-release tablet is designed for once-a-day oral administration. The extended-release tablet uses two release-rate controlling mechanisms: a primary polymer matrix core composed of drug with excipients and a secondary enteric coating surrounding the core. Upon swallowing, water is taken up through the enteric coating membrane into the primary core matrix, and the enteric coating membrane will dissolve at rising gastrointestinal pH value, which in turn slowly releases the drug from the formulation. FDA approved dissolution test specifications differ from USP.