Nebulizer System Slow Infusion for Reduced Systemic Exposure
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Solution Overview
Problem
Current aerosol delivery methods, such as jet and vibrating mesh nebulizers, deliver medications as concentrated 'boluses' over short periods, leading to rapid increases in therapeutic agents in the lungs and systemic exposure, causing undesirable safety and tolerability profiles, and are not optimal for chronic respiratory diseases like cystic fibrosis, where patients face extensive treatment burdens.
Innovation Solution
A method of delivering aerosolized active agents as a slow 'infusion' over an extended period using a nebulizer system designed for lower flow rates over several hours or overnight, minimizing off-target effects and allowing for the use of previously unusable formulations and strengths.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If aerosolized medicines are delivered as concentrated boluses over short periods using jet or vibrating mesh nebulizers, then rapid therapeutic effect is achieved, but systemic exposure increases leading to undesirable safety and tolerability profiles
Solution Approach 1:
The patent applies periodic action by delivering aerosolized medicine in multiple smaller boluses spaced over time rather than a single concentrated bolus. This periodic delivery pattern maintains therapeutic effect while reducing peak systemic exposure and associated safety risks.
Solution Approach 2:
The patent segments the total drug dose into multiple smaller boluses delivered at different time points. This segmentation approach distributes the therapeutic load, achieving sustained effect while minimizing the harmful peak exposure that occurs with single-dose administration.
2Adaptability or versatility
If multiple inhaled treatments are added to the treatment regimen during waking hours, then comprehensive disease management is achieved, but treatment burden increases leading to displacement of other treatments or decreased compliance
Solution Approach 1:
The patent employs preliminary action by administering aerosolized medicine during overnight sleep hours before the patient begins their daily activities. This advance delivery during the night reduces the treatment burden during waking hours while maintaining comprehensive disease management.
Solution Approach 2:
The patent adds a temporal dimension to treatment delivery by utilizing overnight hours, a time period previously underutilized for therapy. This dimensional expansion allows comprehensive treatment without increasing burden during critical waking hours.
3Quantity of substance
If aerosolized medicines are delivered as concentrated boluses, then rapid increase in therapeutic agent concentration is achieved, but off-target effects and reduced tolerability occur
Solution Approach 1:
The patent uses periodic action to deliver the therapeutic agent in spaced boluses, maintaining adequate concentration levels over time while preventing the excessive peak concentrations that cause off-target effects and reduce tolerability.
Solution Approach 2:
The patent changes the temporal parameters of drug delivery, transitioning from rapid single-dose administration to extended multi-dose administration. This parameter modification maintains therapeutic efficacy while reducing harmful peak exposure and off-target effects.
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
This approach enhances mucus clearance, reduces treatment burden, minimizes systemic exposure, and improves the therapeutic index of aerosolized medications, making them safer and more effective for chronic respiratory conditions.
Implementation Method 1
Aerosol delivery of active compounds at low rates
Data Source
AI summary
Embodiments disclosed herein are directed to methods, compositions and apparatus for administering active agents to the lungs of a subject.