Spray drying process and compositions of fenofibrate

Details Spray drying process and compositions of fenofibrate Spray drying process and compositions of fenofibrate

A - Human Necessities

61

K

A61K 9/16 (2006.01) A61K 9/14 (2006.01) A61K 31/216 (2006.01) A61K 31/22 (2006.01) A61K 31/365 (2006.01) A61K 31/40 (2006.01) A61K 31/405 (2006.01) A61K 31/44 (2006.01) A61K 31/505 (2006.01) A61K 31/66 (2006.01) A61K 45/06 (2006.01) A61P 3/06 (2006.01)

Patent

CA 2423335

The present invention relates to a novel spray drying process for the preparation of pharmaceutical compositions containing small particles of phospholipid-stabilized fenofibrate. This invention also relates to spray dried powdered compositions prepared according to this process and to dosage forms of fenofibrate (capsules, tablets, powders, granules, and dispersions) prepared from these powdered compositions. The powdered compositions and dosage forms are useful in the treatment of dyslipidemia and dyslipoproteinemia and have the advantage that they provide reduced in vivo variability in the bioavailability of fenofibrate active species among fed and fasted patients when administered orally.

Cette invention se rapporte à un nouveau procédé de séchage par atomisation qui sert à préparer des compositions pharmaceutiques contenant de petites particules de fénofibrate stabilisé par phospholipides. Cette invention concerne également des compositions pulvérulentes séchées par atomisation, préparées selon ledit procédé, et des formes posologiques de fénofibrate (capsules, comprimés, poudres, granulés et dispersions) préparées à partir de ces compositions pulvérulentes. Ces compositions pulvérulentes et ces formes posologiques sont utiles dans le traitement de la dyslipidémie et de la dyslipoprotéinémie et elles ont l'avantage de réduire la variabilité in vivo de la biodisponibilité des espèces actives de fénofibrate chez des patients nourris et à jeun, lorsqu'elles sont administrées par voie buccale.

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