Stable hydroalcoholic oral spray formulations and methods

Details Stable hydroalcoholic oral spray formulations and methods Stable hydroalcoholic oral spray formulations and methods

A - Human Necessities

61

K

A61K 9/12 (2006.01) A61K 31/5415 (2006.01) A61K 47/10 (2006.01) A61P 29/00 (2006.01)

Patent

CA 2649895

Stable formulations of an active pharmaceutical agent suitable for oral spray administration for absorption by the oral mucosa and related methods of preparation and administration of active pharmaceutical agent formulations are provided. Preferred embodiments of the invention provide formulations comprising an active pharmaceutical agent, a solvent, a buffer, and a viscosity modifying agent, wherein when a unit dose volume of about 25 to 400 mcL of the oral spray composition is sprayed, the spray has a median particle size diameter of about 40 to about 100 microns.

Cette invention concerne des formulations stables d'un agent pharmaceutique actif pouvant être administrées par pulvérisation dans la cavité buccale en vue de son absorption par la muqueuse buccale et concerne également des méthodes associées de préparation et d'administration de formulations d'agent pharmaceutique actif. Des modes de réalisation préférés de cette invention concernent des formulations contenant un agent pharmaceutique actif, un solvant, un tampon et agent modificateur de la viscosité. Selon cette invention, lorsqu'on pulvérise un volume de dose unitaire d'environ 25 à 400 mcL de la composition à pulvériser dans la cavité buccale, la composition présente un diamètre moyen de la taille des particules compris entre 40 et 100 microns environ.

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