Isosorbide mononitrate compositions and methods of their use

A - Human Necessities – 61 – K

Patent

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Details

A61K 31/34 (2006.01) A61K 9/14 (2006.01) A61P 9/00 (2006.01) A61P 9/10 (2006.01)

Patent

CA 2495071

The present invention relates to delayed onset, extended release formulations of isosorbide mononitrates (ISMNs), and methods of their use in treating, preventing, reducing, reversing, and/or managing nitrate tolerance and/or cardiovascular conditions. In particular, the present invention is directed to once-daily delayed onset, extended release formulations that (1) provide a subject with a therapeutically effective amount of ISMNs during the early morning hours prior to and after awakening, (2) continue to provide therapeutically effective amounts of ISMN throughout the waking hours of the day, and (3) provide a reduction, or washout, of ISMN plasma levels to treat, prevent, reduce, reverse, and/or manage nitrate tolerance.

La présente invention concerne des formulations de monotritates d'isosorbide (ISMN) à libération prolongée et à délai d'action et des procédés d'utilisation de ces dernières pour traiter, prévenir, réduire, inverser et/ou gérer la tolérance aux nitrates et/ou les états cardiovasculaires. En particulier, l'invention concerne des formulations à libération prolongée et à délai d'action à dose quotidienne unique qui (1) fournissent à un sujet une quantité thérapeutiquement efficace d'ISMN dans les premières heures de la matinée qui précèdent ou qui suivent le réveil ; (2) continuent à fournir au sujet des quantités thérapeutiquement efficaces d'ISMN au cours des heures d'éveil de la journée ; et (3) permettent une réduction, ou une élimination, des niveaux plasmiques d'ISMN dans le but de traiter, prévenir, réduire, inverser et/ou gérer la tolérance aux nitrates.

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