Intranasal formulations for promoting sleep and method of...

A - Human Necessities – 61 – F

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A61F 13/02 (2006.01) A61K 9/00 (2006.01) A61K 31/4402 (2006.01) A61K 47/20 (2006.01)

Patent

CA 2266898

Intranasal dosage units for promoting sleep in a mammal are disclosed. The dosage units are in the form of an aqueous buffered solution having a pH greater than 7.0, a sleep-promoting amount of Doxylamine, and an effective amount of an anionic surfactant. The anionic sufactant amount is an amount effective to provide a peak plasma concentration of Doxylamine to be reached within 30 minutes of administering the dosage unit to the nasal mucosa of a mammal. The dosage units are particularly suitable for administration to humans.

L'invention concerne des unités posologiques intranasales destinées à favoriser le sommeil chez un mammifère. Les unités posologies ont la forme d'une solution aqueuse tamponée au pH supérieur à 7.0, possédant une dose de Doxylamine favorisant le sommeil, et une dose efficace de surfactant anionique. La dose de surfactant anionique est une dose efficace pour atteindre une concentration maximum de Doxylamine dans le plasma au cours des trente minutes qui suivent l'administration de l'unité posologique dans la muqueuse nasale d'un mammifère. Les unités posologiques sont particulièrement adaptées à l'administration aux humains.

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