Aerosol composition for administering drugs

Abstract

Described here are compositions and methods for the treatment of respiratory conditions using glucocorticosteroids delivered by a next generation nebulizer. The methods administer a therapeutic dose with nebulization time of 2 minutes or less. The faster nebulization time improves patient compliance.

What is claimed is: 
     
         1 . An aqueous dispersion or suspension of a drug wherein when a therapeutic dose is administered by a next generation nebulizer to generate an inhaled aerosol composition:
 said aerosol composition comprises drug particles having a mean diameter from about 1 micron to about 3 microns;   said aerosol composition has a fine particle fraction of at least about 25% to about 33.8%;   the nebulization time is in the range of about 15 seconds to about 120 seconds; and   about 39% or less of the drug particles are retained on the mesh after the nebulization time.   
     
     
         2 . An aqueous dispersion or suspension of a drug as described in  claim 1  wherein said drug has a concentration from about 0.01 milligrams/milliliter to about 50 milligrams/milliliter. 
     
     
         3 . An aqueous dispersion or suspension of a drug as described in  claim 1  further comprising a dispersion enhancer in a concentration from about 0.001 w/w % to about 10 w/w %. 
     
     
         4 . An aqueous dispersion or suspension of a drug as described in  claim 1  wherein said drug comprises a compound selected from the group consisting of 21-acetoxypregnenolone, alclometasone, algestone, amcinonide, beclomethasone, betamethasone, budesonide, chloroprednisone, ciclesonide, clobetasol, clobetasone, clocortolone, cloprednol, corticosterone, cortisone, cortivazol, deflazacort, desciclesonide, desonide, desoximetasone, dexamethasone, diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort, flucloronide, flumethasone, flunisolide, fluocinolone acetonide, fluocinonide, fluocortin butyl, fluocortolone, fluorometholone, fluperolone acetate, fluprednidene acetate, fluprednisolone, flurandrenolide, fluticasone propionate, formocortal, halcinonide, halobetasol propionate, halometasone, halopredone acetate, hydrocortamate, hydrocortisone, loteprednol etabonate, mazipredone, medrysone, meprednisone, methylprednisolone, mometasone furoate, paramethasone, prednicarbate, prednisolone, prednisolone 25-diethylamino-acetate, prednisolone sodium phosphate, prednisone, prednival, prednylidene, rimexolone, tixocortol, triamcinolone, triamcinolone acetonide, triamcinolone benetonide, triamcinolone hexacetonide, (11b,16a)-16,17-[butylidenebisbis(oxy)]-11,21-dihydroxy-16-methylpregna-1,4-diene-3,20-dione 21-[(4′-nitrooxymethyl)benzoate] and derivatives, analogues, enantiomer forms, stereoisomers, anhydrides, acid addition salts, base salts, solvates, and combinations thereof. 
     
     
         5 . An aqueous dispersion or suspension of a drug as described in  claim 1  wherein said drug is budesonide. 
     
     
         6 . An aqueous dispersion or suspension of a drug as described in  claim 1  wherein said drug is selected from the group consisting of mometesone furoate, (11b,16a)-16,17-[butylidenebisbis(oxy)]-11,21-dihydroxy-16-methylpregna-1,4-diene-3,20-dione 21-[(4′-nitrooxymethyl)benzoate], and ciclesonide. 
     
     
         7 . An aqueous dispersion or suspension of a drug as described in  claim 1  wherein said aerosol composition further comprises a dispersion enhancer selected from the group consisting of polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, lecithin, polyethylene glycol, polyvinylpyrrolidone and poloxamer. 
     
     
         8 . An aqueous dispersion or suspension of a drug as described in  claim 7  wherein the dispersion enhancer is polysorbate 80. 
     
     
         9 . An aqueous dispersion or suspension of a drug as described in  claim 8  wherein said polysorbate 80 is present in a concentration in the range of about 50 micrograms per milliliter to about 200 micrograms per milliliter. 
     
     
         10 . An aqueous dispersion or suspension of a drug as described in  claim 8  wherein said polysorbate 80 is present in a concentration in the range of about 100 micrograms per milliliter to about 200 micrograms per milliliter. 
     
     
         11 . An aqueous dispersion or suspension of a drug as described in  claim 8  wherein said polysorbate 80 is present in a concentration in the range of about 120 micrograms per milliliter to about 130 micrograms per milliliter. 
     
     
         12 . An aqueous dispersion or suspension as described in  claim 1 , wherein the nebulization time for administering the therapeutic dose is about 60 seconds or less. 
     
     
         13 . An aqueous dispersion or suspension of a drug as described in  claim 1  wherein said drug is present at a concentration of about 0.2 milligrams/milliliter. 
     
     
         14 . An aqueous dispersion or suspension of a drug as described in  claim 1  wherein the aerosol composition has a fine particle fraction of least about 25%. 
     
     
         15 . A therapeutic dose comprising an aqueous dispersion or suspension of budesonide particles, wherein:
 said aqueous dispersion or suspension comprises polysorbate 80 at a concentration in range of about 120 micrograms per milliliter to about 130 micrograms per milliliter;   said budesonide particles have a mean diameter from about 1 microns to about 3 microns;   said therapeutic dose is administered by a next generation nebulizer to generate an inhaled aerosol composition; wherein   said aerosol composition has a fine particle fraction is at least 25%;   said therapeutic dose can be administered a period of about 15 seconds to about 120 seconds; and   wherein 39% or less of the budesonide particles retained on the mesh of the nebulizer.   
     
     
         16 . The therapeutic dose of  claim 15 , wherein the budesonide particles have a mean diameter of about 1.5 microns to about 2.5 microns. 
     
     
         17 . The therapeutic dose of  claim 15 , wherein the aerosol composition has a particle size that is about 5.0 microns or less.