CONCENTRATED AQUEOUS AZALIDE FORMULATIONS

摘要

Provided is concentrated aqueous azithromycin formulation from about from about 2%-20%, and a method of making a concentrated aqueous azithromycin formulation which includes preparing and sterilizing a first solution comprising a strong base to form a sterilized solution, dissolving the azithromycin in an aqueous solution comprising an acid consisting essentially of a strong acid, and adding the aqueous solution comprising the strong acid to the sterilized solution comprising the strong base. The strong acid has a pKa less than about −1.74 and the method is carried out without addition or use of a weak acid.

主权项

1. A method of making a concentrated aqueous azithromycin formulation comprising from about 2% to 20% azithromycin, said method comprising the steps of:
(a) preparing and sterilizing a first solution comprising a polymeric suspending agent the pH of which is adjusted with a strong base to form the first solution, (b) dissolving the azithromycin in an aqueous solution comprising an acid consisting essentially of a strong acid to form a second solution, and (c) adding the second solution comprising the strong acid to the first solution adjusted with the strong base, wherein the strong acid has a pKa less than about −1.74 and the method is carried out without addition or use of a weak acid.