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US 2019/0054095 A1Published application
Aqueous Nebulization Composition
AssigneeNephron Pharmaceuticals Corporation
InventorAshley Daugherty
Life of this patent
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Abstract
Compositions and methods for making and using stable, homogeneous budesonide compositions are disclosed.
Claims20
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 no more than 4:1, relative to the weight of budesonide in the composition;
- and
- iii) at least 90 wt. % water.
1 more element
A homogeneous, pharmaceutical composition comprising:
- i) at least 0.01 wt. % budesonide;
- ii) no more than 0.1 wt. % polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer;
- iii) less than 0.1 wt. % polysorbate 80;
- iv) no more than 0.01 wt. % ethylenediaminetetraacetic acid;
- v) citric acid;
- vi) sodium citrate;
- and
- vii) sodium chloride,
- the pharmaceutical composition exclusive of preservatives.
6 more elements
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.
4 more elements
Dependencies are inferred from the claim text.