IP Library Patent Application 13160009
Patent Application
App. No. 13/160,009

ALBUTEROL AND IPRATROPIUM INHALATION SOLUTION, SYSTEM, KIT AND METHOD FOR RELIEVING SYMPTOMS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE

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Patent No.
US None
App. No.
13/160,009
Abstract

The present invention relates to a dual bronchodilator inhalation solution, system, kit and method for relieving bronchospasm in patients suffering from chronic obstructive pulmonary disease (COPD). In one alternative embodiment, the solution of the present invention is a prepackaged, sterile, premixed, premeasured single unit dose of albuterol and ipratropium bromide for patients suffering from COPD. The present solution may be free of antimicrobial preservatives, such as benzalkonium chloride. In another alternative embodiment, the solution of the present invention comprises about 2.50 mg albuterol and about 0.50 mg ipratropium bromide in a 0.5 ml volume.

Claims (20)

1 . A system for inducing bronchodilation or providing relief of bronchospasm in an individual suffering from chronic obstructive pulmonary disease, said system comprising:

(a) one or more single dispensing containers; and

(b) an aqueous inhalation solution comprising a therapeutically effective amount of albuterol and a therapeutically effective amount of about 0.001 mg to about 1.0 mg of ipratropium bromide;

wherein the aqueous inhalation solution is prefilled in each of the one or more dispensing containers as a premixed, premeasured, single unit dose of about 0.1 ml to about 0.5 ml, the aqueous inhalation solution administered to the individual from a nebulizer chamber such that the mist is removed from the nebulizer chamber in less than 12 minutes when said aqueous inhalation solution is introduced into a high performance nebulizer.

2 . The system of claim 1 , wherein each of the one or more containers is prefilled with about 0.5 ml of the inhalation solution.

3 . The system of claim 1 , wherein said amount of albuterol ranges from about 2.0 mg to about 3.0 mg.

4 . The system of claim 1 , wherein the albuterol is albuterol base, and said amount of albuterol base is about 2.5 mg and the amount of ipratropium is about 0.5 mg.

5 . The system of claim 1 , wherein the inhalation solution in each of the one or more containers is sterile.

6 . The system of claim 1 , wherein the inhalation solution in each of the one or more containers is free of benzalkonium chloride.

7 . The system of claim 1 , wherein the system further comprises a label which indicates that the inhalation solution can be used to relieve bronchospasm associated with chronic obstructive pulmonary disease.

8 . The system of claim 7 , wherein said label comprises instructions for using the solution to relieve said bronchospasm.

9 . The system of claim 7 , wherein said label comprises prescribing information comprising efficacy, dosage, administration, contraindication and adverse reaction information pertaining to the inhalation solution in the container.

10 . The system of claim 1 , wherein the mist is removed from the nebulizer chamber in less than 10 minutes when said formulation is introduced into a high performance nebulizer.

11 . The system of claim 1 , wherein the mist is removed from the nebulizer chamber in less than 8 minutes when said formulation is introduced into a high performance nebulizer.

12 . The system of claim 1 , wherein the mist is removed from the nebulizer chamber in less than 6 minutes when said formulation is introduced into a high performance nebulizer.

13 . The system of claim 1 , wherein the mist is removed from the nebulizer chamber in less than 4 minutes when said formulation is introduced into a high performance nebulizer.

14 . A system for inducing bronchodilation or providing relief of bronchospasm in an individual suffering from chronic obstructive pulmonary disease, said system comprising:

(a) one or more single dispensing containers; and

(b) an aqueous inhalation solution comprising a therapeutically effective amount of albuterol and a therapeutically effective amount of about 0.001 mg to about 1.0 mg of ipratropium bromide;

wherein the aqueous inhalation solution is prefilled in each of the one or more dispensing containers as a premixed, premeasured, single unit dose of about 0.1 ml to about 0.5 ml, the aqueous inhalation solution administered to the individual from the one or more dispensing containers.

Assignments (7)
ADDRESS CHANGE Recorded Mar 15, 2022
From: MYLAN SPECIALTY L.P.
To: MYLAN SPECIALTY L.P.
Reel/Frame 059366/0851 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 24, 2013
From: DEY PHARMA, L.P.
To: MYLAN SPECIALTY L.P.
Reel/Frame 030482/0242 →
PATENT RELEASE Recorded Dec 10, 2012
From: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
To: DEY PHARMA L.P. (F/K/A DEY, L.P.); MYLAN PHARMACEUTICALS, INC.; MYLAN BERTEK PHARMACEUTICALS INC.; MYLAN TECHNOLOGIES, INC.; SOMERSET PHARMACEUTICALS, INC.; MYLAN INSTITUTIONAL INC. (F/K/A UDL LABORATORIES, INC.); MYLAN INC.
Reel/Frame 029440/0967 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2011
From: CHAUDRY, IMTIAZ; BANERJEE, PARTHA
To: DEY, L.P.
Reel/Frame 027369/0991 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 9, 2011
From: CHAUDRY, IMTIAZ; BANERJEE, PARTHA; RICE, CHARLES
To: DEY, L.P.
Reel/Frame 027359/0548 →
CHANGE OF NAME Recorded Dec 9, 2011
From: DEY, L.P.
To: DEY PHARMA, L.P.
Reel/Frame 027360/0090 →
SECURITY AGREEMENT Recorded Nov 21, 2011
From: MYLAN PHARMACEUTICALS, INC.; MYLAN BERTEK PHARMACEUTICALS INC.; MYLAN TECHNOLOGIES, INC.; MYLAN INSTITUTIONAL INC. (F/K/A UDL LABORATORIES, INC.); SOMERSET PHARMACEUTICALS, INC.; DEY PHARMA, L.P. (F/K/A DEY L.P.)
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 027270/0799 →