Anti-migraine oral spray formulations and methods

A - Human Necessities – 61 – K

Patent

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A61K 31/4045 (2006.01) A61K 9/12 (2006.01)

Patent

CA 2659245

Formulations of an active pharmaceutical agent suitable for oral spray administration for absorption through the oral mucosa and related methods of preparation and administration are provided. Preferred embodiments provide sumatriptan succinate in a potassium phosphate buffer, wherein when a unit dose volume of about 50 to about 600 mcL of the oral spray composition is sprayed, a blood concentration of greater than about 5 ng/ml of sumatriptan is reached within about six minutes post dosing.

L'invention concerne des formulations d'un agent pharmaceutique actif conçu pour une administration par aérosol oral en vue de l'absorption par la muqueuse buccale et des procédés associés de préparation et d'administration. Les modes de réalisation préférés proposent le sumatriptan dans un tampon de phosphate de potassium, dans lequel lorsqu'un volume de dose unitaire d'environ 50 à environ 600 mcL de la composition d'aérosol oral est pulvérisé, une concentration sanguine supérieure à environ 5 ng/ml de sumatriptan est atteinte dans les six minutes suivant l'administration.

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