Inhalant Formulation Containing Sulfoalkyl Ether Cyclodextrin and Corticosteroid
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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.
66 Citations
111 Claims
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1-42. -42. (canceled)
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46-70. -70. (canceled)
- 71. A method of treating a disease or disorder of the airways, in a subject in need thereof, comprising administering or delivering, via inhalation, to the subject an aqueous liquid formulation comprising an aqueous liquid carrier, a sulfoalkyl ether cyclodextrin, and a dose of corticosteroid dissolved therein, wherein the formulation provides an enhanced pharmacokinetic profile over a suspension based formulation administered under similar conditions.
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72. A method of administering or delivering a dose of corticosteroid to the air passageways of a subject in need thereof, the method comprising administering or delivering the corticosteroid with a nebulizer comprising a charge of an aqueous liquid formulation, the formulation comprising an aqueous liquid carrier, sulfoalkyl ether cyclodextrin, and the corticosteroid dissolved therein, wherein, during operation, the system provides enhanced drug delivery, increased rate of drug administration, reduced treatment time, reduced toxicity, improved stability, enhanced bioabsorption, increased output rate, increased total output, enhanced pharmacokinetic profile, reduced corticosteroid-related side effects, enhanced pulmonary deposition, reduced oropharyngeal deposition, and/or improved nebulization performance over another system comprising the nebulizer and a suspension based formulation of the corticosteroid.
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101. A system comprising:
- a nebulizer equipped with a reservoir; and
an aqueous liquid formulation comprising an aqueous liquid carrier, solubility enhancer, and a dose of corticosteroid, wherein, during nebulization of the formulation, the nebulizer provides a percentage decrease in the rate of increasing concentration of corticosteroid in the formulation in the reservoir as compared to the rate of increasing concentration of a suspension-based formulation nebulized with the nebulizer under similar conditions. - View Dependent Claims (43, 44, 45, 102, 103, 108, 109, 110, 111)
- a nebulizer equipped with a reservoir; and
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104. A method of treating a disease or disorder of the airways, in a subject in need thereof, comprising administering via inhalation to the subject a liquid formulation comprising an aqueous liquid carrier, a sulfoalkyl ether cyclodextrin, and a dose of corticosteroid dissolved therein, wherein the dose of corticosteroid is present in an amount sufficient to provide a mean plasma AUCt of 160-1600 pg*h/ml, and wherein the molar ratio of SAE-CD to corticosteroid is greater than 10:
- 1.
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105. A method of providing a corticosteroid to a subject, the method comprising:
- administering to the subject, via nebulization, 25-400 μ
g of a corticosteroid dissolved in an aqueous liquid carrier comprising sulfoalkyl ether cyclodextrin to provide a plasma AUCt of 150-1600 pg*h/ml for the corticosteroid.
- administering to the subject, via nebulization, 25-400 μ
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106. A method of providing in a subject a plasma AUCt, normalized for dose of corticosteroid, of at least 6 (pg*h/ml)/μ
- g of corticosteroid, comprising;
administering to the subject, via nebulization, a dose of at least 25 μ
g of corticosteroid dissolved in an aqueous liquid carrier comprising sulfoalkyl ether cyclodextrin.
- g of corticosteroid, comprising;
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107. A method of providing in a subject an AUCi, normalized for dose of corticosteroid, of at least 8 (pg*h/ml)/μ
- g of corticosteroid, comprising;
administering to the subject, via nebulization, a dose of at least 25 μ
g of corticosteroid dissolved in an aqueous liquid carrier comprising sulfoalkyl ether cyclodextrin.
- g of corticosteroid, comprising;
Specification