Dual-Bronchodilator Inhalation Composition With Specific pH Ranges

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Solution Overview

Problem

Current treatments for chronic obstructive pulmonary disease (COPD) and asthma, while including bronchodilators and inhaled corticosteroids, face limitations such as side effects and the need for multiple dosing, and there is a lack of effective anti-inflammatory drugs for acute exacerbations.

Innovation Solution

A pharmaceutical composition for inhalation comprising a combination of long-acting β2 agonists and long-acting muscarinic antagonists, optionally with hyaluronic acid, sodium chloride, EDTA, and cyclodextrin, formulated at specific pH ranges to enhance stability and efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If inhaled corticosteroids are used to treat COPD and asthma, then anti-inflammatory effect is improved, but side effects increase and multiple dosing is required

Engineering Contradiction:
Improveanti-inflammatory effectVSAvoidside effects
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent combines two bronchodilators (long-acting beta2 agonist and long-acting muscarinic antagonist) into a single inhalation formulation, allowing simultaneous delivery of multiple therapeutic agents. This merging approach provides comprehensive treatment (bronchodilation plus anti-inflammatory effects from hyaluronic acid) in one dose, reducing the need for multiple separate medications and their associated side effects.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The formulation uses a composite approach by incorporating hyaluronic acid (a natural polysaccharide with anti-inflammatory properties) alongside conventional bronchodilators. This composite formulation provides both bronchodilation and anti-inflammatory effects, reducing reliance on high-dose corticosteroids and their associated side effects.

Inventive Principle:
Principle #40Composite materials

2Ease of operation

If long-acting beta2 agonists are used for bronchodilation, then symptom relief is improved, but bronchiectasis is caused by prolonged smooth muscle relaxation

Engineering Contradiction:
Improvesymptom reliefVSAvoidbronchiectasis
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent introduces long-acting muscarinic antagonists as intermediary agents that counterbalance the excessive bronchodilation effects of beta2 agonists. By simultaneously administering these two agents, the formulation achieves sustained bronchodilation while the muscarinic antagonist prevents over-relaxation of airway smooth muscle, thereby reducing the risk of bronchiectasis.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Adaptability or versatility

If anticholinergic drugs are used as bronchodilators, then substitution for beta2 agonist is possible, but effectiveness declines in older patients

Engineering Contradiction:
Improvesubstitution capabilityVSAvoideffectiveness in older patients
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent creates a universal formulation that combines both long-acting beta2 agonists and long-acting muscarinic antagonists, making the treatment effective across different patient populations including older adults. The dual-agonist approach ensures that patients who respond better to one mechanism over the other will still receive effective treatment, as both pathways are activated simultaneously.

Inventive Principle:
Principle #6Universality (Multi-functionality)

4Reliability

If multiple medications are used for COPD treatment, then comprehensive therapy is achieved, but treatment complexity increases

Engineering Contradiction:
Improvecomprehensive therapyVSAvoidtreatment complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges multiple therapeutic agents (long-acting beta2 agonist, long-acting muscarinic antagonist, and hyaluronic acid) into a single inhalation formulation. This consolidation provides comprehensive treatment covering bronchodilation through two different mechanisms and anti-inflammatory effects, all delivered through one medication regimen, thereby simplifying the treatment complexity while maintaining comprehensive therapy.

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentEP4585215A1Pharmaceutical composition for inhalation for preventing or treating respiratory disease
Publication Date: 2025.07.16 LEXENPHARM (SUZHOU) LTD
  • EP4585215A1 patent drawingFigure 1~3
  • EP4585215A1 patent drawingFigure 4~6
  • EP4585215A1 patent drawingFigure 7~9

AI summary

Disclosed is a pharmaceutical composition for inhalation, comprising long-acting β2 agonist and long-acting muscarinic antagonist. The long-acting β2 agonist comprises olodaterol; or long-acting β2 agonist comprises arformoterol, and the pH of the composition is 3.5-5.5; or long-acting β2 agonist comprises indacaterol, and the pH of the composition is 2.5-4.5; or the long-acting muscarinic antagonist comprises revefenacin, and the pH of the composition is 3.5-5.5; or the long-acting muscarinic antagonist comprises glycopyrronium bromide, and the pH of the composition is 2.5-4.5; or the long-acting muscarinic antagonist comprises tiotropium bromide, and the pH of the composition is 2.0-4.0. Disclosed is a use of the pharmaceutical composition for inhalation for the preventing or treating of respiratory diseases such as asthma, chronic obstructive pulmonary disease, and the like.