Orodispersible tablet having high homogeneity and the...

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/20 (2006.01) A61J 3/10 (2006.01) A61K 9/00 (2006.01) A61K 9/26 (2006.01) A61K 9/50 (2006.01) A61K 31/167 (2006.01) A61K 47/00 (2006.01)

Patent

CA 2465753

The invention relates to a rapid-disintegrating tablet of the type which is intended to disintegrate in the mouth on contact with the saliva in less than 40 seconds, preferably in under 30 seconds, and which forms an easy-to-swallow suspension. The inventive tablet is made from at least one active material which takes the form of coated microcrystals or microgranules and a mixture of excipients in the form of grains. The aforementioned mixture of excipients has the following composition: between 60 and 85 % of a diluent; between 3 and 20 % of a decomposing agent; between 1 and 8 % of a sweetening agent; between 0 and 5 % of a gliding agent; between 0 and 10 % of a binder; and between 0 and 10 % of a permeabilising agent, a swelling agent and/or a lubricant. The above-mentioned percentages are weight percentages in relation to the total weight of the grains of the excipients. Said excipient grains have a median particle size of between +30 and -30 %, and preferably between +10 and -10 %, in relation to the dimension of the coated microcrystals or microgranules.

La présente invention porte sur un comprimé à délitement rapide du genre de ceux qui sont destinés à se désintégrer dans la bouche au contact de la salive en moins de 40 secondes, de préférence en moins de 30 secondes, et en formant une suspension facile à avaler, qui est à base d'au moins une matière active sous forme de microcristaux ou de microgranules enrobés et d'un mélange d'excipients mélange se présentant sous forme de grains, ledit mélange d'excipients présentant la composition suivante: de 60 à 85% d'un diluant, de 3% à 20% d'un agent de désagrégation; de 1% à 8% d'un édulcorant; de 0% à 5% d'un agent d'écoulement; de 0% à 10% d'un liant; de 0% à 10% d'un agent perméabilisant, un agent gonflant et/ou d'un agent lubrifiant; les pourcentages étant des pourcentages en poids par rapport au poids total des grains d'excipients, les grains d'excipients ayant une granulométrie médiane comprise entre +30 et -30%, de préférence entre +10 et -10%, par rapport à la dimension des microcristaux ou microgranules enrobés.

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