Controlled release pharmaceutical compositions containing...

A - Human Necessities – 61 – K

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A61K 31/4535 (2006.01) A61K 9/20 (2006.01) A61K 9/26 (2006.01)

Patent

CA 2299464

Controlled release oral pharmaceutical preparations are provided which comprise a therapeutically effective amount of tiagabine or a pharmaceutically acceptable salt thereof dispersed in a rate controlling polymeric matrix comprising at least one rate controlling polymer. The preparation can be formulated into oral dosage forms such as tablets or multiparticulates which provide therapeutically effective plasma levels of tiagabine for a period of at least 12 hours, preferably 24 hours or more. The preparation can provide tiagabine mean plasma concentrations equal to or greater than 50 % of the maximum plasma concentration for at least 10 hours, preferably 14 hours, most preferably 16 hours or more.

L'invention concerne des préparations pharmaceutiques orales à libération lente, qui comprennent une dose thérapeutiquement efficace de tiagabine ou un sel pharmaceutiquement acceptable de celui-ci, dispersé(e) dans une matrice polymère de régulation de vitesse comprenant au moins un polymère de régulation de vitesse. La préparation peut être formulée sous forme de formes galéniques orales, tels que des comprimés ou des multiparticules qui produisent des taux de plasma thérapeutiquement efficaces de tiagabine pendant une période d'au moins 12 heures, de préférence 24 heures ou plus. La préparation peut produire des concentrations de plasma moyennes de tiagabine supérieures ou égales à 50 % de la concentration de plasma maximum, pendant au moins 10 heures, de préférence 14 heures, idéalement 16 heures ou plus.

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