Systems and methods for the delivery of corticosteroids having an increased lung deposition
First Claim
1. An inhalable composition comprising an effective amount of a single corticosteroid, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a nebulizer, the composition achieves at least about 35% lung deposition based on the amount of corticosteroid in the composition prior to administration, and wherein the composition is substantially free of active pharmaceutical agents other than the corticosteroid.
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Accused Products
Abstract
The present invention relates to methods and systems for the delivery of a corticosteroid comprising (1) an inhalable aqueous mixture comprising a corticosteroid and a solubility enhancer and (2) an inhalable nebulizer, wherein the delivery of the aqueous mixture comprising the corticosteroid by the nebulizer results in an enhanced pharmacokinetic profile of the corticosteroid as compared to conventional inhalable therapies.
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Citations
99 Claims
- 1. An inhalable composition comprising an effective amount of a single corticosteroid, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a nebulizer, the composition achieves at least about 35% lung deposition based on the amount of corticosteroid in the composition prior to administration, and wherein the composition is substantially free of active pharmaceutical agents other than the corticosteroid.
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12. A method of generating fine particles from an inhalable composition comprising:
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adding a solvent and a solubility enhancer to an effective amount of corticosteroid, and operating a nebulizer to produce fine particles of said composition, wherein upon administration of the composition to a subject through the nebulizer, the method achieves at least about 35% lung deposition based on the amount of corticosteroid in the composition prior to administration, and wherein the composition is substantially free of active pharmaceutical agents other than the corticosteroid. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. An inhalation system for delivering a therapeutically effective dose of a single corticosteroid to a patient comprising:
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(a) an aqueous inhalation mixture comprising the corticosteroid and a solubility enhancer, and (b) a nebulizer whereby upon administration of the composition to a subject through said nebulizer, the system achieves at least about 35% lung deposition based on the amount of corticosteroid in the mixture prior to administration, and wherein the composition is substantially free of active pharmaceutical agents other than the corticosteroid. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30)
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31. A method for the treatment of a bronchoconstrictive disorder in a patient in need of treatment thereof, comprising:
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forming a mixture by adding a solvent and a solubility enhancer to an amount of a single corticosteroid and operating a nebulizer, wherein upon administration of the mixture to a subject through the nebulizer, the method achieves at least about 35% lung deposition based on the amount of corticosteroid in the mixture prior to administration, and wherein the composition is substantially free of active pharmaceutical agents other than the corticosteroid. - View Dependent Claims (32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47)
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- 48. An inhalable composition comprising an effective amount of budesonide, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a nebulizer, the composition achieves at least about 35% lung deposition based on the amount of budesonide in the composition prior to administration wherein the composition is substantially free of active pharmaceutical agents other than the budesonide.
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59. An inhalable composition comprising about 60 μ
- g budesonide, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a nebulizer, the composition achieves lung deposition of at least 20 μ
g of budesonide, wherein the composition is substantially free of active pharmaceutical agents other than the budesonide.
- g budesonide, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a nebulizer, the composition achieves lung deposition of at least 20 μ
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60. An inhalable composition comprising about 120 μ
- g budesonide, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a nebulizer, the composition achieves lung deposition of at least 40 μ
g of budesonide, wherein the composition is substantially free of active pharmaceutical agents other than the budesonide.
- g budesonide, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a nebulizer, the composition achieves lung deposition of at least 40 μ
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61. An inhalable composition comprising about 240 μ
- g budesonide, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a nebulizer, the composition achieves lung deposition of at least 80 μ
g of budesonide, wherein the composition is substantially free of active pharmaceutical agents other than the budesonide.
- g budesonide, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a nebulizer, the composition achieves lung deposition of at least 80 μ
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62. A method of generating fine particles from an inhalable composition comprising:
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adding a solvent and a solubility enhancer to an effective amount of budesonide, and operating a nebulizer to produce fine particles of said composition, wherein upon administration of the composition to a subject through the nebulizer, the method achieves at least about 35% lung deposition based on the amount of budesonide in the composition prior to administration, and wherein the composition is substantially free of active pharmaceutical agents other than budesonide. - View Dependent Claims (63, 64, 65, 66, 67, 68, 69, 70, 71)
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72. An inhalation system for delivering a therapeutically effective dose of budesonide to a patient comprising:
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(a) an aqueous inhalation comprising budesonide and a solubility enhancer, and (b) a nebulizer whereby upon administration of the composition to a subject through said nebulizer, the system achieves at least about 35% lung deposition based on the amount of budesonide in the mixture prior to administration, and wherein the mixture is substantially free of active pharmaceutical agents other than budesonide. - View Dependent Claims (73, 74, 75, 76, 77, 78, 79, 80)
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81. A method for the treatment of a bronchoconstrictive disorder in a patient in need of treatment thereof, comprising:
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forming a mixture by adding a solvent and a solubility enhancer to an amount of budesonide and operating a nebulizer, wherein upon administration of the mixture to a subject through the nebulizer, the method achieves at least about 35% lung deposition based on the amount of budesonide in the mixture prior to administration, and wherein the composition is substantially free of active pharmaceutical agents other than budesonide. - View Dependent Claims (82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99)
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Specification