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US 2007/0166240 A1Published application
Bronchodilating beta-agonist compositions and methods
AssigneeDey, L.P.
InventorsPartha Banerjee, Imtiaz Chaudry, Stephen Pham
Life of this patent
Estimating the term…
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.
Claims19
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 μg/mL to about 43 μg/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.
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 μg/mL to about 43 μg/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.
A sterile unit dose, comprising:
- (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 μg/mL to about 43 μg/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.
The sterile unit dose of claim 14, wherein said buffer has a concentration of from about 1 mM to about 20 mM.
Dependencies are inferred from the claim text.