AQUEOUS OPHTHALMIC FORMULATIONS BASED ON AZITHROMYCIN

摘要

The invention concerns topical ophthalmic preparations in the form of eye-drops in aqueous solution, containing azithromycin (or a pharmacologically acceptable salt thereof) as active ingredient, wherein the azithromycin is solubilized and stabilized by means of β-cyclodextrins, and in particular by means of the β-cyclodextrin called sulfobutyl ether β-cyclodextrin (SBE-β-CD).;The proposed preparations have a remarkably high stability, both physical and chemical, which enables its storage at room temperature for the envisaged period of validity for a commercial pharmaceutical product.

主权项

1. A topic ophthalmic preparation in aqueous solution containing azithromycin as active ingredient, solubilized and stabilized with a sulfoalkyl ether β-cyclodextrin (SAE-β-CD), said preparation having a pH comprised between 6.0 and 7.6 and a concentration of azithromycin, or of a pharmacologically acceptable salt or hydrate thereof, comprised between 0.5 and 2.5% by weight.