BRONCHODILATING BETA-AGONIST COMPOSITIONS AND METHODS
First Claim
Patent Images
1. A method of oral administration 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 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.; and
(b) directly administering said composition to a subject in need thereof, without dilution or other modification of said prior to administration.
7 Assignments
0 Petitions
Accused Products
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.
-
Citations
11 Claims
-
1. A method of oral administration 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 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.; and
(b) directly administering said composition to a subject in need thereof, without dilution or other modification of said prior to administration. - View Dependent Claims (4, 5, 6, 7, 8, 9, 10, 11)
-
-
2. A method of oral administration 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 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.; and
(b) directly administering said composition to a subject in need thereof, without dilution or other modification of said prior to administration.
-
-
3. A method of oral administration 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 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 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.
-
Specification