SPL Set ID: 9ad201de-fa62-4c49-bc61-ee09b9ba434c
1 drug(s) with this SPL Set ID
Fenofibric acid is a peroxisome proliferator-activated receptor (PPAR) alpha agonist 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 molecular 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, hydroxypropyl cellulose, hypromellose, methacrylic acid and ethyl acrylate copolymer dispersion (contains polymer substance based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), povidone, sodium stearyl fumarate, talc and triethyl citrate. The empty hard gelatin capsule shells contain gelatin, iron oxide yellow and titanium dioxide. In addition 45 mg contain iron oxide black, and iron oxide red and 135 mg contain FD & C Blue 1, FD & C Red 3 and FD & C Red 40. In addition, the black imprinting ink contains black iron oxide, potassium hydroxide and shellac. Chemical Structure