Galenic formulations of organic compounds

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/14 (2006.01) A61K 9/00 (2006.01) A61K 9/20 (2006.01) A61K 9/28 (2006.01) A61K 9/48 (2006.01) A61K 31/165 (2006.01)

Patent

CA 2749531

The present application relates to a solid unit dosage form for oral administration in form of a tablet having a core and an outer coating, wherein - the core of said tablet comprises a therapeutically effective amount of Aliskiren, or a pharmaceutically acceptable salt thereof, and - the outer coating is in form of a film-coat which has taste masking properties and/or a controlled release functionality. Preferably, the core tablet is part of a multiparticulate system, particularly a minitablet. The solid oral dosage form is particularly suitable for pediatric use.

La présente invention concerne une forme de dosage unitaire solide pour administration orale sous la forme d'un comprimé, doté d'une partie centrale et d'un enrobage externe. Ladite partie centrale dudit comprimé comprend une quantité thérapeutiquement efficace d'Aliskiren, ou un sel pharmaceutiquement acceptable de celui-ci, et l'enrobage externe se présente sous la forme d'un revêtement de film qui possède des propriétés de masquage de goût et/ou une fonctionnalité de libération contrôlée. De préférence, le comprimé avec partie centrale fait partie d'un système multiparticulaire, et est en particulier un mini-comprimé. La forme de dosage oral solide est particulièrement adaptée à un usage pédiatrique.

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