A solid pharmaceutical composition with a first fraction of...

A - Human Necessities – 61 – K

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A61K 9/28 (2006.01) A61K 31/57 (2006.01) A61K 38/23 (2006.01)

Patent

CA 2611081

A solid pharmaceutical composition in the form of a single dosage unit for oral use, the composition comprising a first and a second fraction, the first fraction comprises a therapeutically and/or prophylactically active substance dispersed in a dispersion medium that is sufficiently fluid at body temperature and the second fraction comprises a matrix comprising a substantially water soluble and/or crystalline polymer or a mixture of substantially water soluble and/or crystalline polymers, the first fraction being included in the composition in such a manner that at least a part of the second fraction is firstly exposed to the gastrointestinal fluids upon administration before the first fraction becomes exposed. The system is designed to release the active substance after a predetermined period of time after administration, and the release of the active substance at that point in time is relatively fast.

La présente invention concerne une composition pharmaceutique solide sous la forme d'une dose unique par voie orale, cette composition comprenant une première et une seconde fraction, la première fraction comprenant une substance thérapeutiquement et/ou prophylactiquement active dispersée dans un milieu de dispersion suffisamment fluide à température corporelle et la seconde fraction comprend une matrice, comprenant un polymère sensiblement soluble dans l'eau et/ou cristallin ou un mélange de polymères solubles dans l'eau et/ou cristallins, cette première fraction étant incluse dans la composition de sorte qu'au moins une partie de la seconde fraction est d'abord exposée aux fluides gastro-intestinaux lors de l'administration avant que la première fraction ne soit exposée. Ce système est conçu de façon à libérer la substance active après une durée prédéterminée suivant l'administration, et la libération de cette substance active à ce moment est relativement rapide.

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