Stable anti-nausea oral spray formulations and methods

A - Human Necessities – 61 – K

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A61K 9/12 (2006.01) A61K 31/4178 (2006.01) A61P 1/08 (2006.01)

Patent

CA 2673049

Stable formulations of selective 5-hydroxytryptamine receptor antagonists for oral spray administration for absorption by the oral mucosa and related methods of preparation and administration are provided. A preferred embodiment includes ondansetron in a concentration of about 5.1 to about 5.2% w/w; propylene glycol in a concentration of about 60.1 to about 60.3% w/w; water in a concentration of about 5.3 to about 5.4% w/w; and ethanol in a concentration of about 27.1 to about 27.3% w/w. Additional preferred embodiments are preservative free and/or non-aqueous or primarily non-aqueous.

L'invention concerne des préparations stables à base d'antagonistes sélectifs des récepteurs de la 5-hydroxytryptamine, à pulvériser, à usage oral, destinées à être absorbées par la muqueuse orale, ainsi que des méthodes de préparation et d'administration associées. Dans un mode de réalisation préféré, la préparation comprend entre 5,1 et 5,2% en poids environ d'ondansétron, entre 60,1 et 60,3% en poids environ de propylène glycol, entre 5,3 et 5,4% en poids environ d'eau, et entre 27,1 et 27,3% en poids environ d'éthanol. Dans d'autres modes de réalisation préférés, les préparations sont exemptes d'agents conservateurs et/ou non aqueuses ou principalement non aqueuses.

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