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

A chronic obstructive, salbutamol technology, applied in the direction of respiratory diseases, inhalers, nervous system diseases, etc., can solve the problems of lack of mixing or dilution instructions, easy loss, treatment failure, etc.

Inactive Publication Date: 2007-04-04
德艾公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example, COPD treatment requires administration of single dosage units divided from multiple dosage units, but instructions for proper mixing or dilution are sometimes lacking, or instructions for preparing and using COPD treatment can be difficult to follow or easily lost
A more significant problem is that casual dilution or mixing of COPD medications can lead to wrong dosing
This is particularly disadvantageous for those patients with low tolerance to high-dose asthma medications
Improper mixing can also lead to treatment failure requiring additional medical care and thus increasing time, money and personnel expenditures associated with treatment

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0117] The present invention also provides a process for the preparation of a prepackaged, sterile, pre-measured, pre-mixed and / or BAC-free inhalation solution comprising a single unit dose of a therapeutically effective amount of salbutamine and isobutamine Pratropium. In this embodiment, the method of the invention comprises one or more of the following steps: (i) adding at least a therapeutically effective amount of albuterol and ipratropium to a carrier such as water; (ii) sterilizing the solution and sealing the container. Tonicity regulators may be added to adjust the isotonicity of the solution. Preferably, the solution of the present invention is isotonic, and an osmotic pressure regulator may be added to adjust the isotonicity of the solution to about 280-320 mOsm / kg. Additionally, an acid such as hydrochloride may be added to adjust the pH of the solution to a level of about 3.0 to about 5.0, preferably about 4.0.

[0118] In another embodiment, the method for prep...

Embodiment

[0125] In order to evaluate the efficacy and safety of the inhalation solution of the present invention, a double-blind, randomized, positive control experiment was carried out. The design, results and conclusions of the study are detailed below.

[0126] patient

[0127] A total of 863 patients were initially randomly enrolled into the trial. Patients who meet the criteria in Table 3 are eligible to join.

[0128] design elements

[0129] treat

[0130] The doses of the individual drugs and the combination of ipratropium and albuterol are shown in Table 4 below. Using Pari LC Plus TM Sprayer and Pari Proneb TM Compressor, inhalation administration of all test drugs 4 times a day (ideally every 6 hours). Concomitant use of bronchodilators should be limited during the trial. During the trial, oral and inhaled steroids were allowed, provided that the dose remained constant.

[0131] drug to be tested

[0132] efficacy results

[0133] Of the 863 pati...

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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.

Description

[0001] This application is a divisional application, the international application number of the original application is PCT / US2002 / 033353, the Chinese national application number is 02826226.3, the application date is October 18, 2002, and the invention name is "for alleviating the symptoms of chronic obstructive pulmonary disease albuterol and ipratropium inhalation solutions, systems, kits and methods". [0002] Related application reference [0003] This application is a continuation-in-part of U.S. Application Serial No. 10 / 034,657, filed December 28, 2001, which claims under 35 U.S.C. §119(e) U.S. Provisional Application No. 60 / 346,078, filed October 26, 2001 number priority. The entire disclosures of these prior applications are hereby incorporated by reference. technical field [0004] The present invention relates to combinations of bronchodilator therapies for the relief of symptoms associated with chronic obstructive pulmonary disease. Background technique [0...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K9/08A61K31/216A61K31/137A61P11/00A61P43/00A61K9/00A61K31/135A61K31/46A61K47/04A61K47/18A61K47/26A61M15/00A61P11/08A61P25/00
CPCA61K9/0078A61K31/135A61P11/00A61P11/08A61P25/00A61P43/00
Inventor 伊姆蒂亚兹·肖迪帕索·班纳吉
Owner 德艾公司
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