BRONCHODILATING BETA-AGONIST COMPOSITIONS AND METHODS

• US 20070166236A1
• Filed: 03/20/2007
• Published: 07/19/2007
• Est. Priority Date: 07/10/2003
• Status: Active Grant

• Current Assignee: Dey Pharma LP (Pfizer Inc.)
• Original Assignee: Dey LP (Pfizer Inc.)
• Inventors: Banerjee, Partha, Pham, Stephen, Chaudry, Imtiaz
• Granted Patent: US 7,541,385 B2
• Time in Patent Office: Days
• US Class Current: 424/44
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/205 Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
• CPC Class Codes: A61K 31/46 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
• CPC Class Codes: A61K 9/0078 for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 11/08 Bronchodilators

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.

Claims

1. 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 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) directly administering said composition to a subject in need thereof, without dilution or other modification of said prior to administration.

4. The method of treating undesired and/or uncontrolled bronchoconstriction as in any one of claims 1, 2 and 3 wherein said undesired and/or uncontrolled bronchoconstriction is a symptom or condition of asthma.

5. The method of treating undesired and/or uncontrolled bronchoconstriction as in any one of claims 1, 2 and 3 wherein said undesired and/or uncontrolled bronchoconstriction is a symptom or condition of chronic obstructive pulmonary disease.

6. The method of treating undesired and/or uncontrolled bronchoconstriction as in any one of claims 1, 2 and 3 wherein said buffer is present at a concentration of between about 1 mM and about 50 mM.

7. The method of treating undesired and/or uncontrolled bronchoconstriction as in any one of claims 1 and 2 wherein said buffer is present at a concentration of between about 1 mM and about 20 mM.

8. The method of treating undesired and/or uncontrolled bronchoconstriction as in any one of claims 1, 2 and 3 wherein said composition has a pH of about 5.

9. The method of treating undesired and/or uncontrolled bronchoconstriction of claim 8 wherein said buffer has a pH of about 5.

10. The method of treating undesired and/or uncontrolled bronchoconstriction as in any one of claims 1 and 2, wherein about 2.0 mL of the composition is nebulized.

11. The method of treating undesired and/or uncontrolled bronchoconstriction as in any of claims 1, 2 or 3, wherein said (R) formoterol or a salt thereof is (R) formoterol tartrate.

2. 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 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 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 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.