AU2013201071A1 — Improved medicinal aerosol formulations

USPTO Abstract

The present invention provides a medicinal aerosol suspension formulation for MDI administration, comprising: a) micronized 2-agonist; b) micronized corticosteroid; c) a sub-therapeutic quantity of a moisture-scavenger excipient; and d) a HFA propellant; wherein (a), (b) and (c) and their respective relative amounts are selected such that they associate to form floccules having a density substantially the same as that of the HFA propellant. Figure 1: Aerodynamic particle size distribution of Fluticasone/formoterol formulation batches 2028/1 0AI01 (solid symbols) and 7 (clear symbols) as determined by ACI at 28.3 L/min flow rate, 4 L volume, n=5. Upper graph: fluticasone results; lower graph: formoterol results. - 25.0 ..... ii.... .. ... .. .. ................ ..... ..... .. . . S2 E E E E E E E E 0 10.0 - -R I V V V V V V V (D 0 j 0, 0) a) a .................... .. . . . 6 5 E E E E E E S E 0 8 0 0 2 2 2 PE~ 0 0) Ln) ~ ~ (D V V V V V V V o oo9 ot o0 o0 I 0 N 9v (D M C tM CD) M)