US 9,808,471 B2
Nasal pharmaceutical formulations and methods of using the same
Imtiaz Chaudry, Napa, CA (US)
Assigned to Mylan Specialty LP, Canonsburg, PA (US)
Filed by Imtiaz Chaudry, Napa, CA (US)
Filed on Apr. 16, 2003, as Appl. No. 10/414,682.
Prior Publication US 2004/0208830 A1, Oct. 21, 2004
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/14 (2006.01); A61K 9/12 (2006.01); A61K 31/56 (2006.01); A61K 31/573 (2006.01); A61K 9/00 (2006.01); A61K 31/57 (2006.01); A61K 31/7048 (2006.01); A61L 2/00 (2006.01); A61K 9/10 (2006.01)
CPC A61K 31/573 (2013.01) [A61K 9/0043 (2013.01); A61K 31/56 (2013.01); A61K 31/57 (2013.01); A61K 31/7048 (2013.01); A61L 2/0035 (2013.01); A61K 9/10 (2013.01)] 17 Claims
 
1. A nasal pharmaceutical formulation comprising an aqueous suspension of a therapeutically effective amount of fluticasone propionate, wherein the aqueous suspension comprises 0.04% to 0.06% by weight of suspended solid fluticasone propionate particles having the following particle size distribution profile:
about 10% of the solid fluticasone particles have a particle size of less than 0.4 microns;
about 25% of the solid fluticasone particles have a particle size of less than 0.75 microns;
about 50% of the solid fluticasone particles have a particle size of less than 1.5 microns;
about 75% of the solid fluticasone particles have a particle size of less than 3.0 microns; and
about 90% of the solid fluticasone particles have a particle size of less than 5.3 microns;
wherein the fluticasone is suitable for administration to an individual intranasally,
wherein the formulation further comprises a complexing agent selected from the group consisting of ethylenediaminetetraacetic acid (EDTA), citric acid, nitrilotriacetic acid, and salts thereof,
and wherein greater than 95% of the fluticasone originally present in the formulation remains in the formulation after storage for 12 months at a temperature between 15 to 30° C.; and
wherein the formulation further comprises the following compounds:
(a) microcrystalline cellulose;
(b) carboxymethyl cellulose sodium;
(c) dextrose;
(d) benzalkonium chloride;
(e) polysorbate 80; and
(f) phenylethyl alcohol;
wherein the formulation further comprises zinc chloride; and
wherein the formulation is sterile.