Albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease

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.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. application Ser. No. 11 / 037,574 filed Jan. 18, 2005, that is a continuation-in-part of U.S. application Ser. No. 10 / 417,723, now abandoned, filed Apr. 15, 2003, and is also a continuation-in-part of International Application PCT / US04 / 011705 filed Apr. 15, 2004. The latter two applications are continuations-in-part of U.S. application Ser. No. 10 / 162,460, now U.S. Pat. No. 6,632,842, filed Jun. 3, 2002, which is a continuation-in-part of U.S. application Ser. No. 10 / 034,657, now abandoned, filed Dec. 28, 2001, and International Application PCT / US02 / 33353 filed Oct. 18, 2002, which both claim priority under 35 U.S.C. §119 from U.S. Provisional Application Ser. No. 60 / 346,078 filed Oct. 26, 2001. The entire disclosure of each of these prior applications is incorporated herein by reference in its entirety. Both above-identified international applications were published in English under PCT Article 2(...

AI Technical Summary

Benefits of technology

The present invention provides a dual bronchodilator inhalation solution for the relief of bronchospasm in patients suffering from COPD. This solution contains a combination of albuterol and ipratropium, which are administered through a pre-measured, pre-packaged, sterile, and BAC-free formulation. The invention also provides a method for administering the solution, a kit or system for use in relieving bronchospasm associated with COPD, and a process for making the solution. The technical effects of the invention include improved bronchospasm relief, improved patient outcomes, and improved quality of life for patients with COPD.

Problems solved by technology

COPD is clearly a major and growing health care threat in the U.S. and throughout the rest of the world.

However, case reports suggest that repeated use of COPD treatments with BAC may result in paradoxic bronchoconstriction.

When inhaled by COPD subjects, BAC may also cause dose-dependent bronchoconstriction.

This poses several problems.

For instance, COPD treatments requiring administration of a single dose unit from multiple dosage units sometimes lack proper mixing or diluting instructions, or the instructions for preparing and using the COPD treatment may be hard to follow or can be easily lost.

Of even greater import is haphazard diluting or mixing of COPD medications, which can result in administering the wrong dosage.

This could be especially harmful for patients less tolerant to higher dosages of asthma medications.

Incorrect mixing can also result in treatment failure such that additional medical attention is required, thereby increasing the time, expense and personnel costs associated with therapy.

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