SPL Set ID: 8ffcb173-095a-4550-84f2-18959ad2aab8
1 drug(s) with this SPL Set ID
Fenofibric acid delayed-release capsules are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as delayed release capsules for oral administration. Fenofibric acid delayed-release capsules are a lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2-hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula: The empirical formula is C 22 H 28 ClNO 5 and the molecular weight is 421.91. Choline fenofibrate is freely soluble in water and methanol. The melting point is approximately 210°C. Choline fenofibrate is a white to off-white crystalline powder, which is stable under ordinary conditions. Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: colloidal silicon dioxide, hydroxylpropyl cellulose, hypromellose, methacrylic acid copolymer, povidone, sodium stearyl fumarate, talc, triethyl citrate, water. The capsule shell of the 45 mg capsule contains the following inactive ingredients: gelatin, iron oxide red, iron oxide yellow and titanium dioxide. The capsule shell of the 135 mg capsule contains the following inactive ingredients: FD&C Blue #2, gelatin, iron oxide yellow and titanium dioxide. The capsule shells are printed with edible black ink and white ink. The edible white ink contains potassium hydroxide, propylene glycol, shellac and titanium dioxide and the edible black ink contains iron oxide black, potassium hydroxide, propylene glycol and shellac. structure