Orodispersible tablets containing fexofenadine

A - Human Necessities – 61 – K

Patent

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Details

A61K 31/445 (2006.01) A61K 9/00 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/50 (2006.01) A61K 47/12 (2006.01) A61K 47/26 (2006.01) A61K 47/30 (2006.01) A61P 11/00 (2006.01)

Patent

CA 2466580

The present invention concerns orodispersible tablets, which are able to disintegrate in the buccal cavity upon contact with saliva by formation of an easy-to-swallow suspension, in less than 60 seconds, preferably in less than 40 seconds, containing fexofenadine in the form of coated granules, and a mixture of excipients comprising at least one disintegrating agent, a soluble diluent agent, a lubricant and optionally a swelling agent, a permeabilising agent, sweeteners, flavoring agents and colors; the process for obtaining such orodispersible tablets and the coated granules incorporated therein and the use of said orodispersible tablets in the treatment of seasonal allergic rhinitis.

L'invention concerne des comprimés orodispersibles, capables de se désintégrer dans la cavité buccale dès contact avec la salive, par formation d'une suspension facile à avaler en moins de 60 secondes, de préférence en moins de 40 secondes. Ces comprimés contiennent du fexofenadine sous forme de granules enrobés, et un mélange d'excipients comprenant au moins un agent de désintégration, un agent diluant soluble, un lubrifiant et éventuellement un agent de gonflement, un agent perméabilisant, des édulcorants, des aromatisants et des colorants. L'invention concerne également le procédé permettant d'obtenir de tels comprimés orodispersibles et les granulés enrobés incorporés dans ces comprimés, ainsi que l'utilisation de ces comprimés orodispersibles dans le traitement de la rhinite allergique saisonnière.

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