Controlled-release pharmaceutical composition and method for...

A - Human Necessities – 61 – K

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A61K 31/4439 (2006.01) A61K 9/14 (2006.01) A61K 9/36 (2006.01) A61K 9/62 (2006.01) A61K 47/06 (2006.01) A61K 47/10 (2006.01) A61K 47/12 (2006.01) A61K 47/14 (2006.01) A61K 47/32 (2006.01) A61K 47/38 (2006.01) A61P 1/04 (2006.01) C07D 401/12 (2006.01)

Patent

CA 2557791

It is an object of the present invention, in the case of a controlled-release pharmaceutical composition, particularly a pulsed-release pharmaceutical composition, containing an acid-unstable physiologically active substance, to provide a pharmaceutical composition having little variation in dissolution lag time and high reliability of dissolution characteristics. The present invention discloses a controlled-release pharmaceutical composition comprising: 1) a core containing an acid-unstable physiologically active substance and a disintegrant; and 2) a release-controlling coating which covers the core, and which contains a water-insoluble polymer, an enteric polymer and a hydrophobic wax.

Préparations de lessivage maîtrisé contenant une substance active physiologiquement instable dans les acides, en particulier, préparations de lessivage pulsé de faible fluctuation de retard de phase et aux performances de lessivage plus fiables. Il est prévu des préparations de lessivage maîtrisé comprenant un noyau (1) contenant une substance active physiologiquement instable dans les acides et un désintégrant de même qu'un revêtement de lessivage maîtrisé (2) recouvrant le noyau et contenant un polymère insoluble dans l'eau, un polymère entérique et une cire soluble dans la graisse.

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