Controlled release pharmaceutical preparation and method for...

A - Human Necessities – 61 – K

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A61K 9/58 (2006.01) A61K 9/50 (2006.01)

Patent

CA 2033277

The present invention is directed to a controlled release pharmaceutical preparation comprising (a) a core containing a pharmaceutically active substance and an organic acid, and (b) a coating film formed on the surface of the core by aqueous coating of a water-insoluble and a slightly water-permeable acrylic polymer containing a trimethylammonium-ethyl group, which exhibits well controlled dissolution and release of the pharmaceutically active substance when administered and can maintain the desired blood level of the active substance for a long period of time. The invention is also directed to a method for producing the preparation.

L'invention porte sur une préparation pharmaceutique à libération-retard, composée (a) d'un noyau renfermant une substance pharmaceutique et un acide organique, (b) une pellicule d'enrobage, appliquée sur le noyau par revêtement aqueux d'un polymère acrylique insoluble dans l'eau, mais légèrement perméable à celle-ci, contenant un groupe triméthylammonium-éthyle qui possède une bonne capacité de dissolution et de libération de la substance pharmaceutique après administration, permettant ainsi de maintenir la concentration souhaitée de la substance dans le sang pendant une période prolongée. L'invention porte également sur une méthode pour produire la préparation.

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