Triple Therapy Inhalation Microparticles for Distal Airway Delivery
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Solution Overview
Problem
Current treatments for severe COPD lack effective delivery of triple therapy combinations of anticholinergics, beta 2-adrenoceptor agonists, and inhaled corticosteroids to the distal airways, leading to variability in dose delivery and inadequate therapeutic control of small airway diseases.
Innovation Solution
Development of multicomponent microparticles comprising beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide in a specific weight ratio, produced through a process involving solvent preparation, aerosol generation, and drying to achieve uniform, small particle size for inhalation, ensuring consistent delivery to the distal respiratory tract.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If combination therapy with triple therapy (anticholinergic + inhaled corticosteroid + long-acting beta2-agonist) is used to address multiple disease components, then clinical benefits are improved, but manufacturing precision and dose delivery consistency deteriorate
Solution Approach 1:
The invention segments the triple therapy combination into separate functional components delivered through distinct inhalation devices or formulations. Each active ingredient (anticholinergic, inhaled corticosteroid, long-acting beta2-agonist) is formulated separately to maintain manufacturing precision and dose consistency, while still achieving comprehensive disease management through coordinated administration.
Solution Approach 2:
The patent applies local quality by optimizing the formulation and delivery characteristics for each specific active ingredient based on its unique pharmacological properties. Each component is tailored with appropriate particle size, solubility, and delivery mechanism suited to its specific therapeutic role, ensuring optimal dose delivery consistency for each substance while maintaining the overall efficacy of the combination therapy.
2Adaptability or versatility
If current combined inhalation products are used, then multiple active ingredients are delivered, but variability in dose delivery increases
Solution Approach 1:
The invention divides the multi-ingredient inhalation product into separate, independently optimized formulations for each active ingredient. This segmentation allows each component to be manufactured and delivered with precise control over its specific properties, eliminating the dose delivery variability that arises from attempting to combine multiple substances in a single formulation.
Solution Approach 2:
The patent utilizes parameter changes by adjusting critical formulation parameters (particle size distribution, solubility, crystallinity) for each active ingredient to optimize its delivery characteristics. By controlling these parameters independently for each substance, the invention achieves consistent and reproducible dose delivery while maintaining the ability to deliver multiple active ingredients.
3Reliability
If particle size is reduced to reach distal airways, then therapeutic control of small airways is improved, but manufacturing complexity increases
Solution Approach 1:
The invention employs parameter changes by systematically controlling particle size parameters (median diameter, geometric standard deviation) to achieve the optimal range for distal airway penetration (1-5 micrometers). By precisely adjusting these parameters during the manufacturing process, the patent achieves reliable therapeutic control of small airways while maintaining a manageable manufacturing process through established aerosolization techniques.
Solution Approach 2:
The patent applies periodic action through the use of cyclic manufacturing processes such as spray drying or aerosol generation followed by controlled drying cycles. These periodic actions enable consistent production of particles with the required size distribution for distal airway delivery, achieving therapeutic reliability through repeatable, standardized manufacturing cycles.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The microparticles provide a stable and effective delivery of all three active ingredients to the distal airways, enhancing therapeutic control of COPD and other respiratory diseases by maintaining a consistent active ingredient ratio and achieving a high fraction of extrafine particles for improved treatment outcomes.
Implementation Method 1
b) generating an aerosol from the solution of said three active ingredients
Implementation Method 2
c) drying the atomized droplets to yield the microparticles
Data Source
Figure 1
AI summary
The invention relates to particles comprising a combination of an anticholinergic, a beta2-adrenoceptor agonist, and an inhaled corticosteroid, process for their preparation and use thereof for the prevention and/or treatment of respiratory diseases.