Intranasal Aerosol Delivery Valve for Olfactory Region Dosing
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Solution Overview
Problem
Current drug delivery methods for nasal-to-brain targeting face challenges such as rapid drug elimination, variability due to individual nasal anatomy, limited dosage volume, and inefficiency in reaching the olfactory region, especially for high molecular weight substances, with existing devices like nasal pumps and pressurized metered dose inhalers failing to provide high-plume velocity and precise dosing.
Innovation Solution
A device for heterogenous aerosolization that includes a vial with a fluid inlet and outlet, configured for nasal cavity delivery, using excipients and an activation mechanism to release substances as aerosol, ensuring efficient delivery of Topiramate or other substances directly to the brain, with precise dosing and rapid release within 500 milliseconds.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If nasal pump sprays or droppers are used for intranasal delivery, then the device is simple and easy to operate, but the delivery efficiency to the olfactory region is low and rapid elimination occurs
Solution Approach 1:
The patent employs a pressurized metered dose inhaler (pMDI) mechanism that uses compressed gas to deliver a high-velocity aerosol plume through the nasal cavity. The pneumatic propulsion system generates sufficient force to transport drug particles rapidly to the olfactory region, overcoming the low delivery efficiency of passive spray methods while maintaining ease of operation through a simple actuation button.
Solution Approach 2:
The invention changes the physical parameters of drug delivery by transforming the drug into an aerosol formulation with specific particle size distribution (1-10 micrometers). This parameter change enables the drug to remain suspended in the high-velocity gas stream and reach the olfactory region effectively, while the metered dose mechanism controls the amount delivered to prevent overdose.
2Quantity of substance
If high dosage volume is administered to overcome limited dispersion, then more drug reaches the target, but dripping and swallowing occur reducing effectiveness
Solution Approach 1:
The patent utilizes phase transition by delivering the drug as an aerosol (suspended liquid particles in gas) rather than as bulk liquid. The high-velocity gas stream evaporates the liquid vehicle rapidly, leaving dry drug particles that deposit on the nasal mucosa without dripping. This phase transition from liquid to aerosol to deposited solid eliminates the harmful dripping and swallowing effects while delivering adequate dosage.
Solution Approach 2:
The compressed gas stream provides pneumatic propulsion that rapidly transports the aerosolized drug through the nasal cavity to the olfactory region. The high velocity (plume) ensures complete delivery within seconds, preventing gravity-induced dripping and swallowing while maintaining adequate dosage delivery to the target site.
3Reliability
If frequent use of intranasal devices is implemented to maintain therapeutic levels, then treatment effectiveness improves, but nasal mucosal surface is harmed
Solution Approach 1:
The patent employs a disposable pMDI device that is used once or a limited number of times and then discarded. This eliminates the need for cleaning and sterilization, ensuring consistent performance across uses. The disposable nature also prevents cross-contamination and reduces the risk of introducing pathogens to the nasal mucosa during frequent use, thereby maintaining treatment effectiveness while protecting the mucosal surface.
Solution Approach 2:
The patent uses an excipient or carrier substance as an intermediary between the drug and the nasal mucosa. This intermediary protects the mucosal surface from direct contact with potentially irritating drug formulations while facilitating drug delivery. The excipient can be selected to be biocompatible and non-irritating, allowing frequent use without damaging the nasal mucosa.
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
Enhances the efficacy of Topiramate delivery by bypassing systemic absorption, reducing side effects, and providing targeted delivery to the CNS, while allowing for precise dosing and rapid administration.
Implementation Method 1
a pressurized gas flow FR [m/sec] is forced through an orifice D [mm] forming a plume of aerosol from a mixture of a predetermined volume Vgas}
Implementation Method 2
delivering a predetermined volume Vsub} of the substance and a predetermined volume Vgas} of pressurized gas through an orifice
Data Source
AI summary
The present invention provides means and methods for delivering a predetermined volume of a substance, within at least one body cavity of a subject, comprising a predefined volume for containing the predetermined volume of the at least one substance; a delivery end for placement in proximity to the body cavity; the delivery end comprises at least one orifice of diameter D [mm]; a valve mechanically connectable to the container, characterized by at least two configurations: (i) an ACTIVE CONFIGURATION in which the valve enables delivery of predetermined volume Vsub [ml] of the substance; and, (ii) an INACTIVE CONFIGURATION, in which the valve prevents delivery of the predetermined volume Vsub [ml] of the substance from the container to the body cavity; and a fluid tight chamber configured to contain predetermined volume Vgas [ml] of pressurized gas at a predetermined pressure, Pgas [barg].