Formoterol/steroid bronchodilating compositions and methods of use thereof
First Claim
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1. A method for treating or ameliorting one or more symptoms of a bronchoconstrictive disorder comprising:
- providing a pharmaceutical composition packaged for single dosage administration, the composition including (i) formoterol, or a pharmaceutically acceptable salt or hydrate thereof in solution; and
(ii) a steroidal anti-inflammatory agent, or a pharmaceutically acceptable salt thereof in suspension;
in a pharmacologically suitable fluid comprising water that is propellant-free;
the composition as formulated has an estimated shelf-life of greater than 1 month usage time at 25°
C. and greater than or equal to 1 year storage time when stored at 5°
C., whereby greater than 90% of the initial amount of formoterol in the compositions remains at such time; and
the formoterol free base concentration is about 5 μ
g/mL to about 200 μ
g/mL, whereby the composition is formulated for direct administration to a subject in need thereof; and
without dilution, directly administering an effective amount of the composition as provided to a subject in need of such treatment.
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Abstract
Bronchodilating compositions and methods are provided. The compositions are intended for administration as a nebulized aerosol. In certain embodiments, the compositions contain formoterol, or a derivative thereof, and a steroidal anti-inflammatory agent. Methods for treatment, prevention, or amelioration of one or more symptoms of bronchoconstrictive disorders using the compositions provided herein are also provided.
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Citations
89 Claims
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1. A method for treating or ameliorting one or more symptoms of a bronchoconstrictive disorder comprising:
- providing a pharmaceutical composition packaged for single dosage administration, the composition including (i) formoterol, or a pharmaceutically acceptable salt or hydrate thereof in solution; and
(ii) a steroidal anti-inflammatory agent, or a pharmaceutically acceptable salt thereof in suspension;
in a pharmacologically suitable fluid comprising water that is propellant-free;
the composition as formulated has an estimated shelf-life of greater than 1 month usage time at 25°
C. and greater than or equal to 1 year storage time when stored at 5°
C., whereby greater than 90% of the initial amount of formoterol in the compositions remains at such time; and
the formoterol free base concentration is about 5 μ
g/mL to about 200 μ
g/mL, whereby the composition is formulated for direct administration to a subject in need thereof; and
without dilution, directly administering an effective amount of the composition as provided to a subject in need of such treatment. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81)
- providing a pharmaceutical composition packaged for single dosage administration, the composition including (i) formoterol, or a pharmaceutically acceptable salt or hydrate thereof in solution; and
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82. A method for the treatment or amelioration of one or more symptoms of bronchoconstrictive disorders, comprising:
- (i) providing a packaged pharmaceutical composition comprising formoterol, or a pharmaceutically acceptable salt or hydrate thereof in solution, the pharmaceutical composition being in a pharmacologically suitable fluid comprising water that is propellant-free, wherein;
the composition has an estimated shelf-life of greater than 1 month usage time at 25°
C. and greater than or equal to 1 year storage time when stored at 5°
C. whereby greater than 90% of the initial amount of formoterol in the compositions remains at such time;
the formoterol free base concentration is about 5 μ
g/mL to about 200 μ
g/mL, whereby the composition is formulated at a concentration for direct administration to a human in need thereof;
(ii) without dilution, directly administering an effective amount of the composition as provided to a human; and
(ii) simultaneously with, prior to, or subsequent to administering the formoterol composition, administering an effective amount of a pharmaceutical composition comprising a steroidal anti-inflammatory agent, or a pharmaceutically acceptable salt thereof in suspension, in a pharmacologically acceptable carrier. - View Dependent Claims (83, 84, 85, 86, 87)
- (i) providing a packaged pharmaceutical composition comprising formoterol, or a pharmaceutically acceptable salt or hydrate thereof in solution, the pharmaceutical composition being in a pharmacologically suitable fluid comprising water that is propellant-free, wherein;
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88. A method for the treatment or amelioration of one or more symptoms of bronchoconstrictive disorders, comprising:
- providing a pharmaceutical composition formulated and packaged for single dosage administration, wherein;
the composition contains;
(i) formoterol, or a pharmaceutically acceptable salt or hydrate thereof in solution; and
(ii) a steroidal anti-inflammatory agent, or a pharmaceutically acceptable salt thereof in suspension;
in a pharmacologically suitable fluid comprising water that is propellant-free;
the composition as formulated has an estimated shelf-life of greater than 1 month usage time at 25°
C. and greater than or equal to 1 year storage time when stored at 5°
C. whereby greater than 90% of the initial amount of formoterol in the compositions remains at such time; and
the formoterol free base concentration is about 5 μ
g/mL to about 200 μ
g/mL, whereby the composition is formulated for direct administration to a human in need thereof; and
without dilution, directly administering via nebulization an effective amount of the composition as provided to a subject in need of such treatment. - View Dependent Claims (89)
- providing a pharmaceutical composition formulated and packaged for single dosage administration, wherein;
Specification