Aqueous nebulization composition

1. A stable, homogeneous budesonide composition comprising:

i) 0.0125-0.15 wt. % budesonide;

ii) a polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, present at a weight ratio of less than 3:1, relative to the weight of budesonide in the composition; and

iii) at least 90 wt. % water.

2. The composition of claim 1 , further comprising: polysorbate 80 present at a weight ratio of less than 3:1, relative to the budesonide concentration.

3. The composition of claim 1 , wherein the composition is benzalkonium chloride-free.

4. The composition of claim 1 , wherein the composition is stable following storage in a polyethylene container for 24 months at a temperature of 25° C.

5. The composition of claim 1 , wherein the composition is a dispersion.

6. The composition of claim 1 , wherein the composition is a nanodispersion.

7. A drug product, comprising: a sterile volume of the composition of claim 1 in a single dose, blow-fill-seal container.

8. An aseptic process to form a drug product composition, comprising:

i) injecting a volume of the composition of claim 1 into a sterile blow-fill-seal container; and

ii) sealing the sterile blow-fill-seal container.

9. The process of claim 8 , further comprising: sterilizing the volume of the composition of claim 1 prior to the injecting.

10. The process of claim 8 , wherein the aseptic process is exclusive of sterilization following the sealing.

11. A method of treating, preventing, or ameliorating one or more symptoms of a bronchoconstriction-related disease or disorder, comprising:

nebulizing, by a nebulizer, a unit dose of the composition of claim 1 .

12. A homogeneous, pharmaceutical composition comprising:

i) at least 0.01 wt. % budesonide;

ii) less than 0.05 wt. % polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer;

iii) less than 1 wt. % polysorbate 80;

iv) less than 0.01 wt. % ethylenediaminetetraacetic acid;

v) citric acid;

vi) sodium citrate; and

vii) sodium chloride,

the pharmaceutical composition exclusive of preservatives.

13. A method to prepare a precipitate-free composition, comprising:

i) forming a budesonide-containing first liquid, comprising: dispersing a quantity of budesonide micronized powder in a volume of first liquid;

ii) forming a second liquid, comprising: dissolving a quantity of polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer in a volume of water; and

iii) mixing at least a portion of the budesonide-containing first liquid with a volume of the second liquid for at least 30 minutes to form the precipitate-free composition, the precipitate-free composition comprising at least 90 wt. % water,

wherein the method is exclusive of high shear mixing; and

wherein the precipitate-free composition comprises the composition of claim 1 .

14. The method of claim 13 , wherein the precipitate-free composition is a dispersion.

15. The method of claim 13 , wherein the precipitate-free composition is a nanodispersion.

16. The method of claim 13 , wherein the concentration of budesonide is in the range of 125-1500 mcg budesonide per 2 mL of the precipitate-free composition.

17. The method of claim 13 , wherein the first liquid comprises propylene glycol and/or ethanol.

18. The method of claim 13 , wherein the second liquid comprises polysorbate 80.