Opioid dosage forms having dose proportional steady state...

A - Human Necessities – 61 – K

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Details

A61K 9/22 (2006.01) A61K 9/30 (2006.01) A61K 9/52 (2006.01) A61K 31/485 (2006.01)

Patent

CA 2578540

The present invention relates to a plurality of dosage forms comprising a first dosage form and second dosage form each comprising a therapeutic agent, such as an opioid; wherein the dosage strength of the second dosage form is greater than that of the first dosage form; and wherein the steady state Cave and the steady state AUC of the first and second dosage forms are dose proportional and the single dose Cmax of the second dosage form is less than the minimum level for dose proportionality with respect to the first dosage form. The present invention also relates to methods of administering such dosage forms to a patient, as well as to kits comprising such dosage forms and instructions for administration of the dosage forms to a patient. The inventors believe that the dosage forms and methods of the present invention will lead to improved safety and patient acceptance.

La présente invention a trait à une pluralité de posologies comportant une première posologie et une deuxième posologie chacune comprenant un agent thérapeutique, tel qu'un opioïde, dans laquelle le degré de dosage de la deuxième posologie est supérieur à celui de la première posologie; et dans laquelle l'état stationnaire Cave et la surface sous la courbe de l'état stationnaire de la deuxième posologie est inférieure au niveau minimal pour la proportionnalité de la dose par rapport à la première posologie. La présente invention a également trait à des procédés d'administration de telles posologies à un patient, ainsi qu'à des trousses comportant de telles posologies et des instructions pour l'administration des posologies à un patient. Les auteurs de l'invention sont d'avis que les posologies et procédés de la présente invention vont entraîner une sécurité et une acceptation de patient améliorées.

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