Systems and methods for the delivery of corticosteroids having an enhanced pharmacokinetic profile
First Claim
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1. A method for the treatment or prophylaxis of a bronchoconstrictive disorder in a patient in need thereof, the method comprising:
- (a) providing an aqueous inhalation mixture comprising a single corticosteroid and a solubility enhancer; and
(b) delivering the aqueous inhalation mixture with an inhalation nebulizer wherein the corticosteroid is administered at a nominal dosage of less than about 125 μ
g/dose, and wherein the inhalation mixture is substantially free of pharmaceutically active agents other than the single corticosteroid.
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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, and/or increased lung deposition.
78 Citations
90 Claims
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1. A method for the treatment or prophylaxis of a bronchoconstrictive disorder in a patient in need thereof, the method comprising:
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(a) providing an aqueous inhalation mixture comprising a single corticosteroid and a solubility enhancer; and
(b) delivering the aqueous inhalation mixture with an inhalation nebulizer wherein the corticosteroid is administered at a nominal dosage of less than about 125 μ
g/dose, and wherein the inhalation mixture is substantially free of pharmaceutically active agents other than the single corticosteroid. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. A method for the treatment or prophylaxis of a bronchoconstrictive disorder in a patient in need thereof, the method comprising:
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(a) providing an aqueous inhalation mixture comprising a nominal dosage of a single corticosteroid and a solubility enhancer; and
(b) delivering the aqueous inhalation mixture with an inhalation nebulizer whereby the method delivers at least a two-fold enhanced pharmacokinetic profile of the aqueous inhalation mixture comprising the nominal dosage of the single corticosteroid as compared to a pharmacokinetic profile of an inhalable suspension comprising a nominal dosage of the corticosteroid administered under the same conditions, and wherein the inhalation mixture is substantially free of pharmaceutically active agents other than said corticosteroid. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33)
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34. An inhalation system for the treatment or prophylaxis of a bronchoconstrictive disorder in a patient in need thereof, the system comprising:
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(a) an aqueous inhalation mixture comprising a nominal dosage of a single corticosteroid and a solubility enhancer; and
(b) an inhalation nebulizer for delivering the aqueous inhalation mixture whereupon administration of a nominal dosage of the single corticosteroid to the patient, the system delivers at least a two-fold enhanced pharmacokinetic profile of the aqueous inhalation mixture comprising a nominal dosage of the single corticosteroid as compared to a pharmacokinetic profile of an inhalable suspension comprising a nominal dosage of a corticosteroid administered under the same conditions, and wherein the inhalation mixture is substantially free of pharmaceutically active agents other than the single corticosteroid. - View Dependent Claims (35, 36, 37, 38, 39, 40, 41, 42, 43)
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44. A method for the treatment or prophylaxis of a bronchoconstrictive disorder in a patient in need thereof, the method comprising:
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(a) providing an aqueous inhalation mixture comprising budesonide and a solubility enhancer; and
(b) delivering the aqueous inhalation mixture with an inhalation nebulizer wherein budesonide is administered at a nominal dosage of less than about 250 μ
g/dose and wherein the inhalation mixture is substantially free of pharmaceutically active agents other than budesonide. - View Dependent Claims (45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62)
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63. A method for the treatment or prophylaxis of a bronchoconstrictive disorder in a patient in need thereof, the method comprising:
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(a) providing an aqueous inhalation mixture comprising a nominal dosage of budesonide and a solubility enhancer; and
(b) delivering the aqueous inhalation mixture with an inhalation nebulizer whereby the method delivers at least a two-fold enhanced pharmacokinetic profile of the aqueous mixture comprising the nominal dosage of budesonide, as compared to a pharmacokinetic profile of an inhalable suspension comprising budesonide administered under the same conditions and wherein the inhalation mixture is substantially free of pharmaceutically active agents other than budesonide. - View Dependent Claims (64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78)
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79. An inhalation system for the treatment or prophylaxis of a bronchoconstrictive disorder in a patient in need thereof, the system comprising:
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(a) an aqueous inhalation mixture comprising a nominal dosage of budesonide and a solubility enhancer; and
(b) an inhalation nebulizer for delivering the aqueous inhalation mixture, whereupon administration of a nominal dosage of the budesonide to the patient, the system delivers at least a two-fold enhanced pharmacokinetic profile of the aqueous inhalation mixture comprising a nominal dosage of the budesonide, as compared to a pharmacokinetic profile of an inhalable suspension comprising a nominal dosage of budesonide administered under the same conditions, and wherein the inhalation mixture is substantially free of pharmaceutically active agents other than said corticosteroid and wherein the inhalation mixture is substantially free of pharmaceutically active agents other than budesonide. - View Dependent Claims (80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90)
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Specification