A stable pharmaceutical composition comprising a fixed dose...

A - Human Necessities – 61 – K

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A61K 31/216 (2006.01) A61K 9/16 (2006.01) A61K 9/24 (2006.01) A61K 9/26 (2006.01) A61K 31/366 (2006.01) A61K 31/40 (2006.01)

Patent

CA 2597492

A pharmaceutical composition for oral administration comprising a fixed dose combination of a first solid pharmaceutical composition containing fenofibrate as the active substance and second solid pharmaceutical composition containing an HMG-CoA reductase inhibitor such as a statin as the active substance, wherein the first and the second pharmaceutical compositions are present in separate entities in a single solid dosage form. For example a multilayer tablet, a two-layer tablet, or capsules or sachets containing the active ingredients in separate granulates or beads, either granulate or bead optionally being coated with a protective coating or an entero-coating.

L'invention porte sur une préparation pharmaceutique à administration orale comprenant une première composition solide dont le principe actif est du fénofibrate et une deuxième composition solide dont le principe actif est un inhibiteur de la HMG-CoA réductase tel qu'une statine, les deux compositions étant des entités séparées réunies en une seule forme posologique, qui peut être un comprimé multicouche, un comprimé bicouche, une capsule ou un sachet contenant les principes actifs dans des granulés ou des grains séparés éventuellement enrobés d'un revêtement protecteur ou gastrorésistant.

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