Vibrating Membrane Nebulizer for Levofloxacin Aerosol
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Solution Overview
Problem
Current pharmaceutical compositions and aerosol delivery systems for treating airway infections, particularly caused by gram-negative bacteria, face challenges such as particle size distribution issues, viscosity problems, and difficulty in manufacturing sterile lipid-based colloidal drug carrier systems, leading to inefficient aerosolization and potential irritation.
Innovation Solution
A pharmaceutical aerosol comprising a dispersed liquid phase with levofloxacin and calcium-, magnesium-, or aluminum salts, with a mass median diameter of 1.5 to 6 microns and geometrical standard deviation of 1.2 to 3.0, is developed, along with a nebulizer capable of aerosolizing the composition at a rate of at least 0.1 ml/min, ensuring effective delivery to nasal, sinunasal, or pulmonary regions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional jet nebulizers are used for aerosolizing antibiotic solutions, then the device is simple and widely available, but the particle size distribution is poor and deposition efficiency is low
Solution Approach 1:
The patent changes the physical parameters of the nebulizer system by introducing a vibrating membrane component that oscillates at specific frequencies (e.g., 10-100 Hz) to control droplet size. This parameter change enables precise control over aerosol particle size distribution while maintaining relative device simplicity.
Solution Approach 2:
The patent replaces traditional mechanical jet nebulizer systems with a vibrating membrane-based aerosolization system. This substitution uses vibrational mechanics rather than high-velocity fluid jets to generate aerosols, resulting in superior particle size control and distribution.
2Quantity of substance
If high concentration of antibiotic is used in the aerosol, then treatment efficacy is improved, but viscosity increases and aerosolization becomes inefficient
Solution Approach 1:
The patent adjusts the physical parameters of the liquid formulation, specifically targeting viscosity and surface tension. By controlling these parameters, the system can accommodate higher antibiotic concentrations while maintaining efficient aerosolization performance.
Solution Approach 2:
The patent applies local quality modification by using surfactants or viscosity-modifying agents that are distributed throughout the liquid formulation. These additives locally modify the physical properties of the liquid to enable better aerosolization at high concentrations.
3Measurement precision
If propellants are used in metered-dose inhalers, then measured dose delivery is achieved, but propellant irritation occurs in the mouth and throat
Solution Approach 1:
The patent extracts and removes the propellant component from the aerosolization system entirely. By eliminating the propellant, the system avoids the associated irritation problems while still achieving measured dose delivery through alternative mechanisms such as vibrating membrane aerosolization.
Solution Approach 2:
The patent replaces propellant-driven aerosolization with a vibrating membrane-based system that does not require chemical propellants. This substitution maintains the ability to deliver measured doses while eliminating the harmful propellant irritation effect.
4Manufacturing precision
If aerosol droplet size is reduced below one micron, then deep lung deposition is improved, but the total dose delivery becomes less efficient
Solution Approach 1:
The patent optimizes the physical parameters of the vibrating membrane system to generate aerosols with specific size distributions. By carefully controlling vibration frequency and membrane properties, the system achieves optimal droplet sizes for deep lung deposition while maintaining efficient dose delivery.
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 aerosol achieves high local drug concentration in the lungs and sinuses, improving treatment efficacy and patient compliance by providing a convenient and efficient delivery method with reduced irritation and prolonged retention of the antibiotic.
Implementation Method 1
More recently, ultrasonic and vibrating membrane-type nebulizers were developed
Implementation Method 2
More recently, ultrasonic and vibrating membrane-type nebulizers were developed
Implementation Method 3
A pharmaceutical aerosol comprising a dispersed liquid phase with levofloxacin and calcium-, magnesium-, or aluminum salts, with a mass median diameter of 1.5 to 6 microns
Data Source
AI summary
The present invention provides pharmaceutical aerosols which are useful for the prevention or treatment of infectious diseases of the airways, such as the lungs, the bronchi, or the sinunasal cavities. The aerosols comprise an active agent selected from the group of quinolone antibiotics. Also disclosed are liquid and solid compositions suitable for being converted into the aerosols, and kits comprising such compositions.