Patent ID: 8586094
Filing Date: 2013-11-19
Classification: A61K

Abstract:
1. A pharmaceutically acceptable oral dosage form of fenofibrate comprising fenofibrate present in an amount of from about 15% w/w to about 20% w/w of the dosage form; phospholipid present in an amount of from about 1% w/w to about 8% w/w of the dosage form; a buffer salt present in an amount of from about 0.1% w/w to about 0.5% w/w of the dosage forth; one or more water-soluble bulking agent selected from maltodextrin and mannitol present in an amount of from about 7% w/w to about 20% w/w of the dosage form; a cellulosic additive present in an amount of from about 3% w/w to about 8% w/w of the dosage form; beads or crystals of a pharmaceutically acceptable water-soluble excipient support material present in an amount of from about 12% w/w to 16% w/w of the dosage form; a polyvinylpyrrolidone or crospovidone present in an amount of from about 5% w/w to about 30% w/w of the dosage form; croscarmellose sodium present in an amount of from about 1% w/w to about 6% w/w of the dosage form; granular mannitol present in an amount of from about 3% w/w to about 30% w/w of the dosage form; sodium dodecyl sulfate present in an amount of from about 1% w/w to about 4% of the dosage form; silicon dioxide present in an amount of up to about 1% w/w of the dosage form; and a stearate present in an amount of up to about 1% w/w of the dosage form; wherein the fenofibrate is in the form of microparticles coated with phospholipid, wherein the phospholipid coated microparticles are embedded in a matrix comprising the water-soluble bulking agent, phospholipid that is not coated on the microparticles, the buffer salt and the cellulosic additive, and wherein the surface of the beads or crystals of the pharmaceutically acceptable water-soluble excipient is coated with the matrix.