Nasal Delivery Valve with Penetration Enhancers
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Solution Overview
Problem
Existing nasal delivery devices either focus on improving aerosol formation and dispersion but neglect absorption into the mucosal layer, or enhance absorption but fail to ensure sufficient delivery of the substance to the target tissue, thus not optimizing both aspects simultaneously.
Innovation Solution
A device with a delivery mechanism and composition that includes a valve system for controlled release of a substance, combined with penetration enhancers and mucoadhesive agents, to improve both the delivery and absorption of medications into the nasal cavity, utilizing a pressurized gas to create a pre-aerosolized state that effectively targets the olfactory epithelium.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If the device focuses on improving aerosol formation and dispersion mechanisms, then the delivery of material to the desired area is improved, but the absorption of the compound into and through the mucosal layer is neglected
Solution Approach 1:
The patent employs a composite formulation containing both the active compound and penetration enhancers (such as surfactants, fatty acids, or other mucosal permeability enhancers) that work synergistically to improve both delivery and absorption. This composite approach allows the aerosol to effectively penetrate the mucosal barrier while maintaining sufficient material delivery to the target site.
Solution Approach 2:
The patent modifies the physical and chemical parameters of the formulation by incorporating penetration enhancers that alter the mucosal permeability characteristics. These parameter changes enable the compound to transition from being merely delivered to the surface to being effectively absorbed through the mucosal layer, resolving the absorption neglect issue.
2Reliability
If the device focuses on enhancing absorption into and through the mucosal layer, then the absorption efficacy is improved, but the delivery of sufficient amount of material to the desired tissue is neglected
Solution Approach 1:
The patent applies penetration enhancers in advance within the formulation itself, so that when the aerosol reaches the mucosal surface, the absorption process is already primed and enhanced. This preliminary incorporation of absorption-enhancing agents ensures that sufficient material is not only delivered but also effectively absorbed, preventing the insufficiency problem.
Solution Approach 2:
The penetration enhancers act as intermediary substances that facilitate the transfer of the active compound from the aerosol phase into the mucosal tissue. These intermediaries bridge the gap between delivery and absorption, ensuring that adequate quantities of the compound successfully penetrate the mucosal barrier and reach the target tissue.
3Reliability
If the formulation includes penetration enhancers and mucoadhesive agents, then the absorption and retention of the substance is improved, but the device complexity increases
Solution Approach 1:
The patent combines multiple functional components (active compound, penetration enhancers, and mucoadhesive agents) into a single integrated aerosol formulation. This merging approach delivers multiple benefits simultaneously - improved absorption, enhanced retention through mucoadhesion, and sufficient delivery - while avoiding the need for separate delivery systems, thus managing complexity through integration rather than multiplication of components.
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 device ensures efficient delivery and absorption of medications deep into the nasal passages, achieving targeted deposition and enhanced bioavailability by optimizing the combination of delivery characteristics and formulation, leading to improved efficacy and user compliance.
Implementation Method 1
the pressurized gas, once the valve is reconfigured from the INACTIVE CONFIGURATION to the ACTIVE CONFIGURATION, is adapted to entrain the substance and deliver the same to the body orifice
Implementation Method 2
utilizing a pressurized gas to create a pre-aerosolized state that effectively targets the olfactory epithelium
Implementation Method 3
the substance comprises a penetration enhancer selected from a group consisting of a micro-emulsion, a nano-emulsion of the following: a surfactant, a part of a surfactant, an oil, a co-surfactant, an aqueous phase and any combination thereof; the penetration enhancer allowing: better absorption in the mucosal tissue, better permeation and absorption in the target cells
Implementation Method 4
the substance comprises a mucoadhesive agent such as, but not limited to, bioadhesive proteins, carbohydrates and mucoadhesive polymers
Data Source
AI summary
The present invention provides a device for delivering a predetermined amount of at least one substance to a body orifice of a subject; comprising: a. a container for containing said at least one substance; b. a delivery end for placement in proximity to said orifice, said delivery end being in fluid communication with said container; c. a valve mechanically connectable to said container, characterized by at least two configurations: (i) an ACTIVE CONFIGURATION in which said valve enables delivery of predetermined amount of said substance from said container to said body orifice via said delivery end; and, (ii) an INACTIVE CONFIGURATION, in which said valve prevents delivery of said predetermined amount of said substance from said container to said body orifice; d. a trigger mechanism adapted to reconfigure said valve from said INACTIVE CONFIGURATION to said ACTIVE CONFIGURATION, and vice versa; e. a fluid tight chamber.