Bronchodilating β-agonist compositions and methods
DC CAFCFirst Claim
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1. A sterile unit dose, comprising:
- (a) about 0.1 mL to about 3.0 mL of a pharmaceutical composition comprising formoterol or a salt thereof at a concentration of from about 0.08 μ
g/mL to about 34 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 and phosphate buffer at a concentration of from about 1 mM to about 20 mM, said composition having a pH of between about 4.5 and about 5.5 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 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
18 Claims
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1. A sterile unit dose, comprising:
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(a) about 0.1 mL to about 3.0 mL of a pharmaceutical composition comprising formoterol or a salt thereof at a concentration of from about 0.08 μ
g/mL to about 34 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 and phosphate buffer at a concentration of from about 1 mM to about 20 mM, said composition having a pH of between about 4.5 and about 5.5 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 pharmaceutical packaging material. - View Dependent Claims (5, 6, 7, 16, 17, 18)
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2. A sterile unit dose, comprising:
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(a) about 0.1 mL to about 3.0 mL of a pharmaceutical composition comprising formoterol or a salt thereof at a concentration of from about 0.08 μ
g/mL to about 34 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 and phosphate buffer at a concentration of from about 5 mM to about 20 mM, said composition having a pH of between about 4.5 and about 5.5 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 pharmaceutical packaging material.
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3. A sterile unit dose, comprising:
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(a) about 2 mL of a pharmaceutical composition comprising formoterol or a salt thereof at a concentration of from about 0.08 μ
g/mL to about 26 μ
g/mL based on formoterol free base, in a pharmacologically suitable solution, wherein the composition further comprises water and a citrate buffer at a concentration of from about 1 mM to about 20 mM, said composition having a pH of about 5, 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 vial over wrapped with a laminate.
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4. A sterile unit dose, comprising:
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(a) about 2 mL of a pharmaceutical composition comprising formoterol or a salt thereof at a concentration of from about 0.08 μ
g/mL to about 26 μ
g/mL based on formoterol free base, in a pharmacologically suitable solution, wherein the composition further comprises water and a citrate buffer at a concentration of from about 1 mM to about 50 mM, said composition having a pH of about 5;(b) packaged in a vial over wrapped with a laminate.
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8. A method of oral administration comprising the steps of:
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(a) adding to a nebulizer, from a propellant-free, sterile unit dose package about 1 to about 3 mL of a pharmaceutical composition comprising formoterol or a salt thereof at a concentration of from about 0.08 μ
g/mL to about 34 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 and phosphate buffer at a concentration of from about 1 mM to about 50 mM, said composition having a pH of between about 4.5 and about 5.5; and(b) directly administering said composition to a subject in need thereof, without dilution or other modification of said composition prior to administration.
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9. A method of oral administration comprising the steps of:
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(a) adding to a nebulizer from a propellant-free, sterile unit dose package about 1 to about 3 mL of a pharmaceutical composition comprising formoterol or a salt thereof at a concentration of from about 0.08 μ
g/mL to about 34 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 and phosphate buffer at a concentration of from about 1 mM to about 50 mM, said composition having a pH of between about 4.5 and about 5.5 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.; and(b) directly administering said composition to a subject in need thereof, without dilution or other modification of said composition prior to administration.
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10. A method of oral administration comprising the steps of:
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(a) adding from a propellant-free, sterile unit dose package to a nebulizer about 2 mL of a pharmaceutical composition comprising formoterol or a salt thereof at a concentration of from about 0.08 μ
g/mL to about 26 μ
g/mL based on formoterol free base, in a pharmacologically suitable solution, wherein the composition further comprises water and a citrate buffer at a concentration of from about 1 mM to about 20 mM, said composition having a pH of about 5 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.; and(b) directly administering said composition to a subject in need thereof, without dilution or other modification of said composition prior to administration. - View Dependent Claims (11, 12, 13, 14, 15)
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Specification