Osmotic device containing pseudoephedrine and an h1 antagonist

A - Human Necessities – 61 – K

Patent

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Details

A61K 31/445 (2006.01) A61K 9/22 (2006.01) A61K 9/24 (2006.01) A61K 31/137 (2006.01) A61P 11/02 (2006.01)

Patent

CA 2396145

The present invention provides an osmotic device containing controlled release pseudoephedrine in the core in combi-nation with a rapid release H1 antagonist in an external coat. A wide range of H1 antagonist antihistamines, especially fexofenadine, can be used in this device. Particular embodiments of the invention provide osmotic devices having predetermined release profiles. One embodiment of the osmotic device includes an external coat that has been spray coated rather than compression coated onto the device. The device with spray coated external core is smaller and easier to swallow than the similar device having a compression coated external coat. The device is useful for the treatment of respiratory congestion related disorders and allergy related disorders. The present devices provide PS and an H1 antagonist according to specific release profiles in combination with specific formulations.

L'invention concerne un dispositif osmotique comprenant un noyau qui renferme de la pseudoéphédrine à libération contrôlée associé à un enrobage extérieur qui libère rapidement un antagoniste de H1. Dans ce dispositif, on utilise une grande variété d'antihistamines antagonistes de H1, notamment du fexofenadine. Selon des modes de réalisation particuliers, l'invention concerne des dispositifs osmotiques présentant des profils de libération prédéterminés. Selon un autre mode de réalisation, le dispositif osmotique comprend un enrobage extérieur pulvérisé plutôt que comprimé sur ledit dispositif. Le dispositif à noyau extérieur enrobé par pulvérisation est plus petit et plus facile à avaler qu'un dispositif similaire à enrobage extérieur comprimé. Ce dispositif est utile pour traiter des troubles associés une congestion respiratoire et des troubles associés à une allergie. Le dispositif comprend de la pseudoéphrédine et un antagoniste de H1 conformément aux profils de libération spécifiques associés à des formulations spécifiques.

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