Nasal Delivery System Targeting Upper Posterior Region
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Solution Overview
Problem
Existing drug administration systems to the central nervous system (CNS) often result in low CNS concentrations, leading to high blood plasma levels required for efficacy, which cause systemic side effects and rapid peak plasma profiles, particularly problematic for rapid onset drugs.
Innovation Solution
A nasal delivery system that targets at least 30% of the dose to the upper posterior region of the nasal cavity, posterior to the nasal valve, utilizing a bi-directional airflow mechanism to enhance CNS uptake, bypassing the blood-brain barrier through venous sinuses and olfactory/trigeminal nerve transport mechanisms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If high blood plasma concentrations are used to achieve effective CNS concentrations, then CNS efficacy is improved, but systemic side effects increase
Solution Approach 1:
The invention segments the nasal cavity into different regions (anterior, posterior, upper posterior) and targets drug delivery specifically to the upper posterior region. This spatial segmentation allows the drug to bypass the blood-brain barrier through the olfactory and trigeminal nerves, achieving high CNS concentration without requiring high systemic blood plasma levels, thereby reducing systemic side effects
Solution Approach 2:
The invention uses the olfactory and trigeminal nerves as intermediary pathways to transport the drug directly from the nasal cavity to the CNS. This intermediary route bypasses the blood-brain barrier and systemic circulation, allowing direct CNS delivery without the need for high blood plasma concentrations, thus avoiding systemic side effects
2Speed
If high blood plasma concentrations are used to achieve rapid onset of action, then speed of drug uptake into CNS is improved, but sharp peak plasma profiles are created
Solution Approach 1:
The invention places the drug directly at the site of CNS entry through the upper posterior nasal region, where olfactory and trigeminal nerves are located. This preliminary positioning allows immediate nerve-mediated transport to the CNS, achieving rapid onset of action without the need for gradual buildup through systemic circulation, thus avoiding sharp peak plasma profiles
3Ease of operation
If conventional nasal spray administration is used, then ease of administration is improved, but CNS concentration achieved is insufficient
Solution Approach 1:
The invention modifies the nasal spray system to deliver drug with specific local quality characteristics - targeting the upper posterior nasal region with appropriate particle size, velocity, and distribution patterns. This localized delivery approach ensures the drug reaches the olfactory and trigeminal nerve regions, achieving sufficient CNS concentration while maintaining the ease of spray administration
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
Achieves significantly higher CNS concentrations with reduced systemic side effects and faster onset compared to conventional systems, with a peak CNS effect ratio at least twice that of intravenous delivery, while avoiding sharp peak plasma profiles.
Implementation Method 1
utilizing a bi-directional airflow mechanism to enhance CNS uptake
Implementation Method 2
an increased delivery of substance to the posterior region of the nasal airway, and in particular the upper posterior region of the nasal airway
Data Source
AI summary
A delivery device for and method of providing for delivery of substance to the central nervous system (CNS) of a subject, the delivery device comprising: a nosepiece unit (17) for insertion into a nasal airway (1) of a subject and comprising an outlet unit (21) which includes a nozzle (25) for delivering substance into the nasal airway of the subject; and a substance supply unit which is operable to deliver a dose of substance to the nozzle: wherein the delivery device is configured such that at least 30% of the dose as initially deposited in the nasal airway is deposited in an upper posterior region of the nasal airway, thereby providing a CNS concentration of the substance, and hence CNS effect, which is significantly greater than that which would be predicted from a counterpart blood plasma concentration of the substance.