Sustained release antihistamine and decongestant composition

A - Human Necessities – 61 – K

Patent

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A61K 31/135 (2006.01) A61K 9/24 (2006.01)

Patent

CA 2618702

A controlled-release, non-sedating antihistamine and decongestant composition which provides a 24-hour decongestant dissolution profile using standard ungranulated xanthan gum as the sole controlled-release agent and a process for preparing the same is provided. The pharmaceutical composition of the present invention typically includes: a compressed extended-release core comprising a pharmaceutically effective amount of decongestant, ungranulated xanthan gum, one or more binders, a flow agent, and a lubricant. An immediate- release coating composition is disposed on the core that typically includes a non-sedating antihistamine and at least one coating agent.

L'invention concerne une composition antihistaminique et décongestionnante non sédative, à libération contrôlée, présentant un profil de dissolution produisant un effet décongestionnant pendant 24 heures, et contenant de la gomme de xanthane comme unique agent régulateur de libération, ainsi qu'un procédé permettant de préparer cette composition. La composition pharmaceutique décrite comprend généralement un noyau comprimé à libération prolongée lequel contient une dose pharmaceutiquement efficace de décongestionnant, de la gomme de xanthane non granulée, un ou plusieurs liants, un fluidifiant, et un lubrifiant. Le noyau est recouvert d'une composition d'enrobage à libération immédiate, qui contient généralement un antihistaminique non sédatif, et au moins un agent d'enrobage.

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