EP2601973A1 — Dry powder formulation of azole derivative for inhalation

USPTO Abstract

A spray dried-powder composition for inhalation comprising particles (X) containing (a) between 5 and 50% by weight of at least one azole derivative in amorphous state but not in crystalline structure and (b) at least one matricial agent to the composition selected from a group consisting of polyol such as sorbitol, mannitol and xylitol; a monosaccharides such as glucose and arabinose; disaccharide such as lactose, maltose, saccharose and dextrose; cholesterol, and any mixture thereof, wherein the composition provides a dissolution rate of said azole derivative of at least, 5 % within 10 minutes, 10 % within 20 minutes and 40 % within 60 minutes when tested in the dissolution apparatus type 2 of the United States Pharmacopoeia at 50 rotation per minute, 37 °C in 900 milliters of an aqueous dissolution medium adjusted at pH 1.2 and containing 0.3 % of sodium laurylsulfate.