Bronchodilating beta-agonist compositions and methods

• US 7,462,645 B2
• Filed: 03/20/2007
• Issued: 12/09/2008
• Est. Priority Date: 07/10/2003
• Status: Active Grant

• Current Assignee: Dey Pharma LP (Pfizer Inc.)
• Original Assignee: JP Morgan Chase Bank, N.A. (JP Morgan Chase & Co)
• Inventors: Pham, Stephen, Chaudry, Imtiaz A., Banerjee, Partha S.
• Primary Examiner(s): Henley, III; Raymond J
• Application Number:
  US11/688,429
• Publication Number:
  US 20070160541A1
• Time in Patent Office: 630 Days
• Field of Search: None
• US Class Current: 514/653
• 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 in pharmaceutical packaging material 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 43 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 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 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.

7. The method as in any one of claims 1, 2 and 3 wherein said Pharmaceutical packaging material is selected from the group consisting of blister packs, bottles, tubes, inhalers, pumps, bags, vials, containers and syringes.

8. The method of claim 7 wherein said pharmaceutical packaging material is a vial over wrapped with a laminate.

9. The method as in any one of claims 1 and 2, wherein about 2.0 mL of the composition is nebulized.

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 in pharmaceutical packaging material 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 43 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 prior to administration.

3. 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 in pharmaceutical packaging material 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 43 μ

g/mL based on formoterol free base, in a pharmacologically suitable solution, wherein the composition farther 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.