Aqueous compositions containing corticosteroids for nasal and pulmonary delivery
First Claim
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1. An aerosolized composition for administering a therapeutic dose of a corticosteroid to respiratory tract, consisting essentially of:
- (a) from 5 μ
g/mL to about 5 mg/mL of a dissolved corticosteroid;
(b) from about 0.1 to about 20 percent by weight of a pharmaceutically acceptable, high-HLB surfactant component containing one or more surfactants having an HLB of greater than 10, wherein The high-HLB surfactant component comprises at least 50% by weight of an ethoxylated derivative of vitamin E; and
(c) at least about 70 weight percent aqueous phase.
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Abstract
The present invention provides compositions containing corticosteroid compounds as active agents for the treatment of ailments and diseases of the respiratory tract, particularly the lungs, by way of nasal and pulmonary administration. The corticosteroid compounds are present in a dissolved state in the compositions. The compositions can be formulated in a concentrated, essentially non-aqueous form for storage or in a diluted, aqueous-based form for ready delivery. In a preferred embodiment, the corticosteroid composition contains an ethoxylated derivative of vitamin E and/or a polyethylene glycol fatty acid ester as the high-HLB surfactant present in the formulation. The compositions are ideally suited for inhaled delivery with a nebulizer or for nasal delivery.
320 Citations
29 Claims
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1. An aerosolized composition for administering a therapeutic dose of a corticosteroid to respiratory tract, consisting essentially of:
-
(a) from 5 μ
g/mL to about 5 mg/mL of a dissolved corticosteroid;
(b) from about 0.1 to about 20 percent by weight of a pharmaceutically acceptable, high-HLB surfactant component containing one or more surfactants having an HLB of greater than 10, wherein The high-HLB surfactant component comprises at least 50% by weight of an ethoxylated derivative of vitamin E; and
(c) at least about 70 weight percent aqueous phase. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. An aerosolized composition for administering a therapeutic dose of a corticosteroid to respiratory tract, composing:
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(a) from 5 μ
g/mL to about 5 mg/mL of a dissolve corticosteroid;
(b) from about 0.1 to about 20 percent by weight of a pharmaceutically acceptable, high-HLB surfactant component containing one or more surfactants having an HLB of greater than 10, wherein the high-HLB surfactant component comprises at least 50% by weight of an ethoxylated derivative of vitamin E; and
(c) at least about 70 weight percent aqueous phase. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19)
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20. A method for administering a therapeutic dosage of an aerosolized corticosteroid to respiratory tract of a patient in need thereof, comprising:
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(a) providing a corticosteroid composition comprising;
(1) from 5 μ
g/mL to about 5 mg/mL of a dissolved corticosteroid;
(2) from about 0.1 to about 20 percent by weight of a pharmaceutically acceptable, high-HLB surfactant component containing one or more surfactants having an HLB of greater than 10, wherein the high-HLB surfactant component comprises at least 50% by weight of an ethoxylated derivative of vitamin E; and
(3) at least about 70 weight percent aqueous phase;
(b) aerosolizing the corticosteroid composition; and
(c) administering a therapeutically effective dosage of the aerosolized composition to said patient by inhalation. - View Dependent Claims (21, 22, 23)
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24. A method for administering a therapeutic dosage of an aerosolized corticosteroid composition to the nasal passage of a patient in need thereof, comprising:
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(a) providing a corticosteroid composition comprising;
(1) from 5 μ
g/mL to about 5 mg/L of a dissolved corticosteroid;
(2) from about 0.1 to about 20 percent by weight of a pharmaceutically acceptable, high-HLB surfactant component containing one or more surfactants, having an HLB of greater than 10, wherein high-HLB surfactant component comprises at least 50% by weight of an ethoxylated derivative of vitamin E; and
(3) at least about 70 weight percent aqueous phase, (b) administering a therapeutically effective dosage of the corticosteroid composition by nasal inhalation to said patient. - View Dependent Claims (25, 26)
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27. A method of preparing a diluted corticosteroid composition containing a dissolved corticosteroid, composing:
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(a) dissolving a corticosteroid compound into a molten pharmaceutically acceptable high-HLB surfactant component comprising one or more surfactants having an HLB greater than 10, and wherein the high-HLB surfactant component comprises at least 50 percent by weight of an etioxylated derivative of vitamin E;
(b) subsequently blending The molten high-HLB surfactant component containing the dissolved corticosteroid with an aqueous phase, wherein the aqueous phase is present in an amount of at least about 70 weight percent, and the high-HLB surfactant component is present in an amount of from about 0.1 to about 20 weight percent, of the diluted corticosteroid composition. - View Dependent Claims (28, 29)
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Specification
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Current AssigneeAthena Neurosciences Incorporated (Perrigo Company PLC)
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Original AssigneeElan Corporation PLC (Perrigo Company PLC)
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InventorsSaidi, Zahir, Klyashchitsky, Boris
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Primary Examiner(s)Moezie, T.
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Application NumberUS09/105,838Time in Patent Office1,075 DaysField of Search424/450, 424/45, 424/198.1, 514/179, 514/180US Class Current424/45CPC Class CodesA61K 31/56 Compounds containing cyclop...A61K 31/573 substituted in position 21,...A61K 31/58 containing heterocyclic rin...A61K 9/0043 NoseA61K 9/0078 for inhalation via a nebuli...A61P 11/00 Drugs for disorders of the ...
