Inhalant formulation containing sulfoalkyl ether cyclodextrin and corticosteroid
First Claim
1. An aqueous liquid formulation comprising a therapeutically effective amount of corticosteroid dissolved therein, SAE-CD, and an aqueous liquid carrier, wherein the molar ratio of SAE-CD to corticosteroid is greater than 10:
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Accused Products
Abstract
An inhalable formulation containing SAE-CD and corticosteroid is provided. The formulation is adapted for administration to a subject by nebulization with any known nebulizer. The formulation can be included in a kit. The formulation is administered as an aqueous solution, however, it can be stored as a dry powder, ready-to-use solution, or concentrated composition. The formulation is employed in an improved nebulization system for administering corticosteroid by inhalation. SAE-CD present in the formulation significantly enhances the chemical stability of budesonide. A method of administering the formulation by inhalation is provided. The formulation can also be administered by conventional nasal delivery apparatus.
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Citations
71 Claims
- 1. An aqueous liquid formulation comprising a therapeutically effective amount of corticosteroid dissolved therein, SAE-CD, and an aqueous liquid carrier, wherein the molar ratio of SAE-CD to corticosteroid is greater than 10:
- 48. A method of treating a disease or disorder of the airways, in a subject in need thereof, comprising administering via inhalation a liquid formulation comprising an aqueous liquid carrier, a sulfoalkyl ether cyclodextrin, and a therapeutically effective amount of corticosteroid dissolved therein, the corticosteroid being present in an amount sufficient to provide a mean plasma AUCt of 160-1600 pg*h/ml, wherein the molar ratio of SAE-CD to corticosteroid is greater than 10:
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56. A method of providing a mean plasma AUCt of 150-1600 pg*h/ml for the corticosteroid in an individual subject comprising:
- administering to the subject, via nebulization, 48-220 μ
g, as dose to subject, of a corticosteroid dissolved in an aqueous liquid carrier comprising sulfoalkyl ether cyclodextrin. - View Dependent Claims (57, 58)
- administering to the subject, via nebulization, 48-220 μ
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59. A method of providing in a subject a mean plasma AUCt, normalized for dose of corticosteroid to subject, of at least 6 (pg*h/ml)/μ
- g of corticosteroid delivered, as dose to subject, comprising;
administering to the subject, via nebulization, at least 45 μ
g of corticosteroid dissolved in an aqueous liquid carrier comprising sulfoalkyl ether cyclodextrin. - View Dependent Claims (60, 61, 62, 67, 68)
- g of corticosteroid delivered, as dose to subject, comprising;
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63. A method of providing in a subject a mean AUCi, normalized for dose of corticosteroid to subject, of at least 8 (pg*h/ml)/μ
- g of corticosteroid delivered, as dose to subject, comprising;
administering to the subject, via nebulization, at least 45 μ
g of corticosteroid dissolved in an aqueous liquid carrier comprising sulfoalkyl ether cyclodextrin. - View Dependent Claims (64, 65, 66, 69, 70)
- g of corticosteroid delivered, as dose to subject, comprising;
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71. A method of reducing the amount of time required to provide a therapeutically effective amount of corticosteroid to a subject by inhalation of an corticosteroid-containing composition with a nebulizer, the method comprising the steps of:
- including SAE-CD in the composition in an amount sufficient to solubilize the corticosteroid to form an inhalable aqueous corticosteroid-containing solution; and
administering the solution to the subject by inhalation with a nebulizer, wherein the amount of time required to provide a therapeutically effective amount of corticosteroid to the subject with the solution is reduced as compared to the amount of time required to provide a therapeutically effective amount of corticosteroid to the subject with a corticosteroid-containing suspension comprising the same amount or concentration of corticosteroid when the suspension and solution are administered under otherwise similar nebulization conditions.
- including SAE-CD in the composition in an amount sufficient to solubilize the corticosteroid to form an inhalable aqueous corticosteroid-containing solution; and
Specification