Dry granulated formulations of azithromycin

A - Human Necessities – 61 – K

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A61K 9/20 (2006.01) A61K 31/70 (2006.01)

Patent

CA 2474809

This invention relates to a pharmaceutical formulation, in the form of a tablet, sachet or powder for suspension dosage form, which comprises dry granulated particles of a non-dihydrate form of azithromycin and, optionally, one or more pharmaceutically acceptable excipients. Preferably, the pharmaceutical formulation is a tablet containing between about 40%, by weight, to about 85% , by weight, non-dihydrate azithromycin. More preferably, the pharmaceutical formulation contains non-dihydrate azithromycin selected from the forms B, D, E, F, G, H, J, M, N, 0, P, Q, R, or mixtures thereof. Even more preferably, the invention relates to a pharmaceutical formulation wherein the dosage of azithromycin is 250 mgA, 500 mgA, 600 mgA or 1000 mgA. The present invention further relates to a dry granulated azithromycin particle, comprising a form of azithromycin, selected from forms D, E, F, G, H, J, M, N, 0, P, Q, R and mixtures of non-dihydrate forms, and at least one pharmaceutically acceptable excipient.

L'invention porte sur une préparation pharmaceutique sous forme de comprimé, de sachet ou de poudre pour forme posologique en suspension comportant des particules granulaires azithromycine (pas sous forme de dihydrate) et facultativement un ou plusieurs excipients pharmacocompatibles. La préparation pharmaceutique se présente de préférence en comprimés contenant d'environ 40 % à environ 85 % en poids d'azithromycine (pas sous forme de dihydrate), ou mieux d'azithromycine sous une forme choisie parmi B, D, E, F, G, H, J, M, N, 0, P, Q, R, ou leur mélange, ou encore mieux sous des formes où son dosage est de 250 mgA, 500 mgA, 600 mgA ou 1000 mgA. L'invention porte également sur une particule granulaire d'azithromycine (pas sous forme de dihydrate) se présentant sous une forme choisie parmi D, E, F, G, H, J, M, N, 0, P, Q, R ou leur mélange, associée à au moins un excipient pharmacocompatible.

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