Gatifloxacin-containing aqueous liquid preparation, its...

Details Gatifloxacin-containing aqueous liquid preparation, its... Gatifloxacin-containing aqueous liquid preparation, its...

A - Human Necessities

61

K

A61K 31/496 (2006.01) A61P 27/02 (2006.01) A61P 31/04 (2006.01)

Patent

CA 2718641

There is provided an aqueous liquid preparation comprising 0.65 to 2 w/v% of Gatifloxacin or a pharmacologically acceptable salt thereof or a hydrate thereof as free Gatifloxacin, and at least 0.5 w/v% of at least one of the ingredient selected from the group consisting of phosphoric acid, malonic acid, nicotinamide and a salt thereof, wherein a pH thereof is 5.8 to 6.9. In the aqueous liquid preparation, the solubility of Gatifloxacin is increased and the formation of a precipitate during storage at a lower temperature and at the time of freezing and thawing of the aqueous liquid preparation is suppressed by incorporating at least one of the ingredient selected from the group consisting of nicotinamide, caffeine, methylglucamine and Methyl parahydroxybenzoate into the aqueous liquid preparation.

L'invention concerne un liquide aqueux contenant de la gatifloxacine, un sel de celle-ci pharmacologiquement acceptable ou un hydrate de gatifloxacine ou un sel de celui-ci pharmacologiquement acceptable en quantité comprise entre 0,65 et 2 % en p/v en terme de teneur en gatifloxacine libre et au moins un élément sélectionné parmi l'acide phosphorique, l'acide malonique, l'amide d'acide nicotinique ou leurs sels en quantité équivalant à au moins 0,5 % en p/v et à valeur de pH comprise entre 5,8 et 6,9. Dans le liquide aqueux, la solubilité de la gatifloxacine est augmentée. Lorsqu'au moins un élément sélectionné parmi l'amide d'acide nicotinique, la caféine, la méthylglucamine, le paraoxybenzoate de méthyle et leurs sels, est ajouté au liquide aqueux, la production de précipités dans ledit liquide durant le stockage de celui-ci à basse température ou durant sa congélation/décongélation peut être évitée.

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