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.
Claims11
A method of treating undesired and/or uncontrolled bronchoconstriction comprising the steps of:
- (a) adding to a nebulizer, from a propellant-free, sterile unit dose package 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) directly administering said composition to a subject in need thereof, without dilution or other modification of said prior to administration.
A method of treating undesired and/or uncontrolled bronchoconstriction comprising the steps of:
- (a) adding to a nebulizer from a propellant-free, sterile unit dose package 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.;
- and
- (b) directly administering said composition to a subject in need thereof, without dilution or other modification of said prior to administration.
A method of treating undesired and/or uncontrolled bronchoconstriction comprising the steps of:
- (a) adding from a propellant-free, sterile unit dose package to a nebulizer 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 citrate buffer at a concentration of from about 1 mM to about 20 mM, said composition having a pH of about 4.5 to 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.
Dependencies are inferred from the claim text.