Pediatric formulation of gatifloxacin

A - Human Necessities – 61 – K

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A61K 31/496 (2006.01) C07D 215/56 (2006.01) C07D 401/10 (2006.01)

Patent

CA 2450742

There is provided in accordance with the present invention the quinolone antibacterial gatifloxacin adequately taste-masked so that it can be utilized for pediatric formulations. A crystalline co-precipitate of gatifloxacin and one or both of stearic acid and palmitic acid in a narrow weight ratio has been found to effectively mask the bitter taste of gatifloxacin. The taste of gatifloxacin is effectively masked in the mouth and in aqueous suspension through a full dosage cycle, typically fourteen days. Gatifloxacin in the subject crystalline co-precipitates has been found to be readily available for absorption from the stomach.

L'invention concerne la gatifloxacine antibactérienne de la quinolone, dont le goût est adéquatement masqué afin que l'on puisse l'utiliser dans des formulations pédiatriques. Un co-précipité cristallin de la gatifloxacine et d'au moins un des deux acide stéarique et acide palmitique, dans un rapport de masse étroit, masque efficacement le goût amer de la gatifloxacine. Le goût de la gatifloxacine est efficacement masqué dans la bouche et en suspension aqueuse durant un cycle posologique complet, d'ordinaire quatorze jours. Dans ces co-précipités cristallins, la gatifloxacine s'est avérée d'absorption facilement assimilable de l'estomac.

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