An improved modified release preparation

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/24 (2006.01) A61K 9/20 (2006.01) A61K 9/32 (2006.01) A61K 9/36 (2006.01) A61K 9/50 (2006.01) A61K 31/65 (2006.01)

Patent

CA 2480783

A modified release preparation having one or more coated core elements. Each core element includes an active ingredient and has a modified release coating. A stablising coat is provided between each core element and its modified release coating so that, upon in vitro dissolution testing, the amount of active ingredient released at any time on a post-storage dissolution profile is within 40 percentage points of the amount of active ingredient released at any time on a pre-storage dissolution profile. The invention also provides a method of administering an active ingredient that, upon administration in an immediate release form, normally causes nausea and gastric irritation, the method including administering a modified release preparation of the invention.

Cette invention se rapporte à une préparation à libération modifiée comportant un ou plusieurs éléments noyaux enrobés. Chaque élément noyau contient un principe actif et possède un enrobage à libération modifiée. Un enrobage de stabilisation est prévu entre chaque élément noyau et son enrobage à libération modifiée, pour que, lors d'un test de dissolution in vitro, la quantité de principe actif libérée à n'importe quel moment sur une courbe de dissolution après stockage est inférieure ou égale à 40 points de pourcentage de la quantité de principe actif libérée à n'importe quel moment sur une courbe de dissolution avant stockage. Cette invention concerne également un procédé permettant d'administrer un principe actif qui, lors de son administration sous une forme à libération immédiate, provoque normalement des nausées et des irritations gastriques, ce procédé consistant à administrer une telle préparation à libération modifiée faisant l'objet de cette invention.

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