Composition of and method for preparing orally...

A - Human Necessities – 61 – K

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A61K 9/16 (2006.01) A61K 9/20 (2006.01)

Patent

CA 2673458

The present invention is directed to improved compositions and methods for preparing orally disintegrating tablets (ODTs). In one aspect of the present invention, the ODT further contains at least one active pharmaceutical ingredient (API). In another aspect of the present invention, the ODT contains a high load of at least one API. Specifically, the ODTs described in this invention containing a high load of API can accommodate up to about 70% w/w of active pharmaceutical ingredient in a unit dosage, while exhibiting the desirable attributes of fast disintegration time, acceptable hardness and friability for push through blister and bottle packages, and acceptable mouth feel.

Compositions améliorées et procédés de fabrication pour comprimés à désintégration par voie orale (orally disintegrating tablet/ODT). Selon un aspect de l'invention, les ODT contiennent au moins un principe actif. Selon un autre aspect, ces ODT renferment une forte dose d'au moins un principe actif. Plus précisément, les ODT de l'invention à forte dose de principe actif peuvent recevoir jusqu'à 70 % en poids de principe actif par dose posologique et présentent les caractéristiques requises sous forme de désintégration rapide, dureté et friabilité acceptables pour blisters et conditionnement en flacons, ainsi qu'une sensation en bouche acceptable.

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