Methods and systems for the delivery of corticosteroids
First Claim
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1. An inhalable composition comprising about 250 pg or less of a corticosteroid, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a device, the composition achieves a rate of increasing concentration of the corticosteroid inside the device of about 5 μ
- g/ml per minute or less over administration of the corticosteroid through the device.
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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 increase lung deposition.
106 Citations
104 Claims
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1. An inhalable composition comprising about 250 pg or less of a corticosteroid, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a device, the composition achieves a rate of increasing concentration of the corticosteroid inside the device of about 5 μ
- g/ml per minute or less over administration of the corticosteroid through the device.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- 12. An inhalable composition comprising an effective amount of a corticosteroid, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a device, the composition achieves a rate of increasing concentration of the corticosteroid inside the device of 60% or less of a rate of increasing concentration of the corticosteroid inside the device achieved by an inhalable suspension comprising the corticosteroid without a solubility enhancer administered under the same conditions.
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22. A method of generating fine particles from an inhalable composition comprising:
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forming the composition by adding a solvent and a solubility enhancer to an effective amount of a corticosteroid, and operating a nebulizer to produce fine particles of the composition, wherein upon administration of the composition to a subject through the nebulizer, the composition achieves a rate of increasing concentration of the corticosteroid inside the nebulizer of 60% or less of a rate of increasing concentration of the corticosteroid inside the nebulizer achieved by an inhalable suspension comprising the corticosteroid without a solubility enhancer administered under the same conditions. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31)
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32. An inhalation system for delivering a therapeutically effective dose of a corticosteroid to a patient comprising:
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(a) an aqueous inhalation mixture comprising the corticosteroid, a solvent and a solubility enhancer, and (b) a nebulizer wherein upon administration of the mixture to a subject through the nebulizer, the mixture achieves a rate of increasing concentration of the corticosteroid inside the nebulizer of 60% or less of a rate of increasing concentration of the corticosteroid inside the nebulizer achieved by an inhalable suspension comprising the corticosteroid without a solubility enhancer administered under the same conditions. - View Dependent Claims (33, 34, 35, 36, 37, 38, 39, 40)
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41. The system of claim 332, wherein the nebulizer is selected from jet nebulizers, ultrasonic nebulizers, pulsating membrane nebulizers, nebulizers with a vibrating mesh or plate with multiple apertures, and nebulizers comprising a vibration generator and an aqueous chamber.
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42. A method for the treatment of a bronchoconstrictive disorder in a patient in need of treatment thereof, comprising:
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forming a composition by adding a solvent and a solubility enhancer to an amount of a corticosteroid and operating a nebulizer, wherein upon administration of the composition to a subject through the nebulizer;
the composition achieves a rate of increasing concentration of the corticosteroid inside the nebulizer of 60% or less of a rate of increasing concentration of the corticosteroid inside the nebulizer achieved by an inhalable suspension comprising the corticosteroid without a solubility enhancer administered under the same conditions. - View Dependent Claims (43, 44, 45, 46, 47, 48, 49, 50, 51, 52)
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53. An inhalable composition comprising about 250 μ
- g or less of budesonide, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a device, the composition achieves a rate of increasing concentration of budesonide inside the device of about 5 μ
g/ml per minute or less over administration of the budesonide through the device. - View Dependent Claims (54, 55, 56, 57, 58, 59, 60, 61, 62, 63)
- g or less of budesonide, a solvent and a solubility enhancer, wherein upon administration of the composition to a subject through a device, the composition achieves a rate of increasing concentration of budesonide inside the device of about 5 μ
- 64. 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 device, the composition achieves a rate of increasing concentration of budesonide inside the device of 60% or less of a rate of increasing concentration of budesonide inside the device achieved by an inhalable suspension comprising budesonide without a solubility enhancer administered under the same conditions.
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74. A method of generating fine particles from an inhalable composition comprising:
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forming the composition by adding a solubility enhancer to an effective amount of budesonide, and operating a nebulizer to produce fine particles of the composition, wherein upon administration of the composition to a subject through the nebulizer, the composition achieves a rate of increasing concentration of budesonide inside the nebulizer of 60% or less of a rate of increasing concentration of budesonide inside the nebulizer achieved by an inhalable suspension comprising budesonide without a solubility enhancer administered under the same conditions. - View Dependent Claims (75, 76, 77, 78, 79, 80, 81, 82, 83)
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84. An inhalation system for delivering a therapeutically effective dose of budesonide to a patient comprising:
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(a) an aqueous inhalation mixture comprising budesonide and a solubility enhancer, and (b) a nebulizer wherein upon administration of the mixture to a subject through the nebulizer, the mixture achieves a rate of increasing concentration of budesonide inside the nebulizer of 60% or less of a rate of increasing concentration of budesonide inside the nebulizer achieved by an inhalable suspension comprising budesonide without a solubility enhancer administered under the same conditions. - View Dependent Claims (85, 86, 87, 88, 89, 90, 91, 92, 93)
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94. A method for the treatment of a bronchoconstrictive disorder in a patient in need of treatment thereof, comprising:
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forming a composition by adding a solubility enhancer to an amount of budesonide and operating a nebulizer, wherein upon administration of the composition to a subject through the nebulizer, the composition achieves a rate of increasing concentration of budesonide inside the nebulizer of 60% or less of a rate of increasing concentration of budesonide inside the nebulizer achieved by an inhalable suspension comprising budesonide without a solubility enhancer administered under the same conditions. - View Dependent Claims (95, 96, 97, 98, 99, 100, 101, 102, 103, 104)
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Specification
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Current AssigneeTika Lakemedel AB
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Original AssigneeVerus Pharmaceuticals, Inc.
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InventorsHill, Malcolm
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Application NumberUS11/642,992Publication NumberTime in Patent OfficeDaysField of SearchUS Class Current514/169CPC Class CodesA61K 31/56 Compounds containing cyclop...A61K 47/40 Cyclodextrins; Derivatives ...A61K 9/0078 for inhalation via a nebuli...
