Oral dosage forms comprising fenofibrate

Details Oral dosage forms comprising fenofibrate Oral dosage forms comprising fenofibrate

A - Human Necessities

61

K

A61K 9/20 (2006.01) A61K 9/16 (2006.01) A61K 9/28 (2006.01) A61K 31/216 (2006.01)

Patent

CA 2484375

Disclosed is a pharmaceutically acceptable oral dosage form comprising fenofibrate, phospholipid, a buffer salt, a water-soluble bulking agent selected from maltodextrin, mannitol, and combinations thereof, a cellulosic additive, beads or crystals of a pharmaceutically acceptable water-soluble excipient support material, a polyvinylpyrrolidone or crospovidone, croscarmellose sodium, granular mannitol, sodium dodecyl sulfate, silicon dioxide, and a stearate, wherein the fenofibrate is in the form of microparticles, and wherein at least a portion of the phospholipid is coated on the surfaces of the fenofibrate microparticles, 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 the matrix is coated on up to 100% of the surfaces of the beads or crystals of the excipient support material.

L'invention concerne une forme dosifiée orale acceptable pharmaceutiquement renfermant du fénofibrate, un phospholipide, un sel tampon, un agent gonflant soluble dans l'eau sélectionné parmi la maltodextrine, le mannitol, et des mélanges correspondants, un additif cellulosique, des perles ou des cristaux d'une matière de support d'excipient soluble dans l'eau acceptable pharmaceutiquement, un polyvinylpyrrolidone ou un crospovidone, du sodium de croscarmellose, du mannitol granulaire, du dodécyl sulfate de sodium, du dioxyde de silicium et un stéarate. Ledit fénofibrate se présente sous forme de microparticules, et au moins une partie du phospholipide est recouverte en surface de microparticules de fénofibrate, les microparticules recouvertes du phospholipide sont comprises dans un matrice renfermant l'agent de gonflage soluble dans l'eau, le phospholipide qui ne recouvre pas les microparticules, le sel de tampon et l'additif cellulosique, et la matrice est revêtue jusqu'à 100 % en surface de perles ou de cristaux de la matière de support d'excipient.

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