ANTIBIOTIC FORMULATIONS, UNIT DOSES, KITS, AND METHODS

摘要

An aqueous or powder composition includes anti-gram-negative antibiotic or salt thereof being present at an amount ranging from about 100 mg/ml to about 200 mg/ml. Another aqueous or powder composition includes anti-gram-positive antibiotic or salt thereof being present at a concentration ranging from about 0.6 to about 0.9 of the water solubility limit, at 25° C. and 1.0 atmosphere, of the anti-gram-positive antibiotic or salt thereof. Other embodiments include unit doses, kits, and methods.

主权项

1. A method of producing a unit dose of an aqueous amikacin composition comprising:
a) preparing an amikacin solution by dissolving amikacin sulfate in preservative-free water by stirring; b) adjusting the pH of the amikacin solution, if necessary, until the pH of the solution is between about 5.5 and 6.3; and c) adding about 3 to 10 ml of the amikacin solution to a container in order to generate a unit dose; wherein the unit dose comprises a preservative-free liquid composition for aerosolization having a pH of about 5.5 to about 6.3 and a shelf life of at least two years at room temperature without the formation of precipitate, wherein the unit dose consists essentially of water and about 400 mg to about 750 mg amikacin, at a concentration of about 125 mg/ml; and wherein the unit dose has an osmolarity ranging from about 90 mOsmol/kg to about 500 mOsmol/kg and a potency of amikacin, from about 500 μg/mg to about 1100 μg/mg.