Vibrating Membrane Nebulizer Venting for Biologic Aerosol Stability
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Solution Overview
Problem
Nebulizers for delivering biologic drugs face challenges in maintaining the quality of the aerosol due to foaming and denaturation caused by negative pressure in the reservoir, which affects the delivery of a therapeutically effective dose.
Innovation Solution
A nebulizer design with a vibratable membrane and a piezoelectric actuator that minimizes shear forces and heat input, combined with a plenum chamber and a passive vent to maintain atmospheric pressure, reduces foaming and enhances aerosol quality.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a sealed reservoir is used to increase nebulization efficiency through negative pressure, then productivity is improved, but the liquid solution foams and biologics denaturize due to air suction and oxygen introduction
Solution Approach 1:
The patent extracts the harmful effect of negative pressure by introducing a passive vent that allows air to enter the reservoir, eliminating the pressure differential that causes foaming and denaturation while maintaining adequate nebulization performance
Solution Approach 2:
The patent converts the harmful negative pressure into a beneficial feature by using it to drive liquid flow through the membrane while the passive vent prevents harmful effects, thus achieving both efficient nebulization and prevention of biologic degradation
2Object-affected harmful factors
If a vibratable membrane with piezoelectric actuator is used to minimize shear forces on biologics, then the destruction of biologics is reduced, but the liquid solution tends to foam due to negative pressure generation
Solution Approach 1:
The patent removes the harmful negative pressure effect by adding a passive vent to the reservoir system, allowing air to enter and equalize pressure while the vibratable membrane continues to generate aerosol with minimal shear forces
3Temperature
If energy is supplied only to the piezoelectric actuator for gentle aerosolization, then heat generation is minimized and biologic destruction is avoided, but foaming occurs due to uncontrolled negative pressure in the reservoir
Solution Approach 1:
The patent extracts the harmful negative pressure that causes foaming by introducing a passive vent, allowing the low-energy piezoelectric actuation to proceed without generating harmful pressure differentials
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 design ensures minimal destruction of biologics, maintains aerosol quality, and achieves a high delivered dose with reduced residue, while preventing foaming and denaturation.
Implementation Method 1
a piezoelectric actuator for vibrating the membrane, whereby an aerosol of the liquid solution is generated at the active area
Implementation Method 2
a vibratable membrane having an active area with apertures, wherein the liquid solution is feedable to the active area... the piezoelectric actuator for vibrating the membrane
Implementation Method 3
the liquid solution is feedable to the active area at a liquid side of the membrane, for example by gravitational force
Data Source
AI summary
The present disclosure relates to a drug-device combination comprising a liquid solution (26) containing a biologic; and a nebulizer (10) for aerosolization of the liquid solution (26), the nebulizer (10) comprising a reservoir (24) for holding the liquid solution (26), the reservoir (24) having a vent (48) for maintaining atmospheric pressure in the reservoir (24), a vibratable membrane (60) having an active area (62) with apertures (110), wherein the liquid solution (26) is feedable to the active area (62) at a liquid side (64) of the membrane (60), a piezoelectric actuator for vibrating the membrane (60), whereby an aerosol of the liquid solution (26) is generated at the active area (62) at an aerosol side (66) of the membrane (60), the aerosol side (66) of the membrane (60) being opposite to the liquid side (64) of the membrane (60) and a plenum chamber (23) having an inlet (76) at an inlet side at the aerosol side (66) of the membrane (60) and an outlet (94) at an outlet side for administering the aerosol, the outlet (94) of the plenum chamber being opposite to the inlet (76) of the plenum chamber (23).


