Patent ID: 8153601
Filing Date: 2012-04-10
Classification: A61K,A61P

Abstract:
1. An azithromycin-containing aqueous pharmaceutical composition, which comprises water, at least one member selected from the group consisting of azithromycin, and a pharmaceutically acceptable thereof in an amount of 0.1 to 5.0 w/v % as weight of azithromycin, and at least one additive for increasing heat stability of azithromycin in an aqueous solution selected from the group consisting of monoethanolamine, diethanolamine, triethanolamine, and a pharmaceutically acceptable salt thereof, and which does not comprise boric acid or pharmaceutically acceptable salts thereof, wherein: the composition further comprises citric acid in an amount of 0.02 to 1.0 w/v %; the composition has a pH of from 6.0 to 7.5; the composition is a clear solution, and the composition has a heat stability such that a weight ratio of azithromycin content remaining in the composition after packing in a glass vial, sealed and stored at 60° C. for one week to the initial content of azithromvcin in the composition is at least 70%.