Bronchodilating beta-agonist compositions and methods
First Claim
Patent Images
1. A sterile unit dose, comprising:
- (a) between about 0.1 to about 3.0 mL of a pharmaceutical composition comprising (R) formoterol or a salt thereof at a concentration of from about 0.08 μ
g/mL to about 43 μ
g/mL based on formoterol free base, in a pharmacologically suitable solution, wherein the composition further comprises water and a buffer having a concentration of from about 1 mM to about 50 mM, said composition having a pH of about 4.0 to about 6.0, and having an estimated shelf life of greater than about 94% after 3 months storage at 25°
C. and greater than about 96% after 3 months storage at 5°
C.;
(b) packaged in a pharmaceutical packaging material.
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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. 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
19 Claims
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1. A sterile unit dose, comprising:
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(a) between about 0.1 to about 3.0 mL of a pharmaceutical composition comprising (R) formoterol or a salt thereof at a concentration of from about 0.08 μ
g/mL to about 43 μ
g/mL based on formoterol free base, in a pharmacologically suitable solution, wherein the composition further comprises water and a buffer having a concentration of from about 1 mM to about 50 mM, said composition having a pH of about 4.0 to about 6.0, and having an estimated shelf life of greater than about 94% after 3 months storage at 25°
C. and greater than about 96% after 3 months storage at 5°
C.;(b) packaged in a pharmaceutical packaging material. - View Dependent Claims (3, 4, 5, 6, 7, 8, 9, 10, 11)
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2. A sterile unit dose, comprising:
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(a) between about 0.1 to about 3.0 mL of a pharmaceutical composition comprising (R) formoterol or a salt thereof at a concentration of from about 0.08 μ
g/mL to about 43 μ
g/mL based on formoterol free base, in a pharmacologically suitable solution, wherein the composition further comprises water and a buffer having a concentration of from about 1 mM to about 50 mM, said composition having a pH of about 4.0 to about 6.0, and having an estimated shelf life of greater than 90% after 3 months storage at 25°
C. and after 3 years storage at 5°
C.;(b) packaged in a pharmaceutical packaging material.
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12. A sterile unit dose, comprising:
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(a) about 0.1 to about 3 mL of a pharmaceutical composition comprising (R) formoterol or a salt thereof at a concentration of from about 0.08 μ
g/mL to about 43 μ
g/mL based on formoterol free base, in a pharmacologically suitable solution, wherein the composition further comprises water and a buffer selected from the group consisting of citric acid/phosphate buffer, acetate buffer, citrate buffer or phosphate buffer at a concentration of from about 1 mM to about 50 mM, said composition having a pH of about 4.5 to about 5.5;(b) packaged in a pharmaceutical packaging material. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19)
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Specification