Dual-Density Intranasal Formulations for Longer Drug Retention
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Solution Overview
Problem
Existing intranasal drug delivery methods face challenges in achieving sufficient retention time and precision dosing of therapeutic agents in the nasal cavity, leading to inefficiencies and waste due to variable formulation retention times and limited biocompatibility of delivery systems.
Innovation Solution
Dual-density formulations are used, comprising an upper, lighter fluid for therapeutic agent delivery and a lower, denser fluid to enhance retention and minimize waste, with the denser fluid supporting the lighter fluid to concentrate it against the olfactory region and obstruct the nasal cavity, forming separate layers at intranasal conditions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If a single fluid formulation is used for intranasal delivery, then the device structure is simple, but the retention time of therapeutic agent in the nasal cavity is insufficient and variable
Solution Approach 1:
The formulation is segmented into two distinct immiscible fluid layers: an upper lighter fluid containing the therapeutic agent and a lower denser fluid. This segmentation allows each layer to perform its specific function - the upper layer provides therapeutic delivery while the lower layer extends retention time, thereby resolving the contradiction between simple formulation structure and sufficient retention time.
Solution Approach 2:
The invention changes the density parameter of the formulation by introducing a denser lower fluid layer. This parameter change creates a stable stratified structure where the denser fluid remains at the bottom and the lighter therapeutic fluid remains at the top, providing both structural stability and extended retention time in the nasal cavity.
2Measurement precision
If the upper fluid is delivered to target area, then therapeutic dose is administered, but variable retention time leads to dosage imprecision and waste
Solution Approach 1:
The denser lower fluid acts as a feedback mechanism that continuously supports and retains the upper therapeutic fluid layer in the nasal cavity. This support mechanism ensures that the therapeutic agent remains in contact with the target area for a consistent, extended period, thereby improving dosage precision and reducing waste from premature clearance or variable retention.
Solution Approach 2:
The denser lower fluid layer serves as a protective cushion that prevents the upper therapeutic fluid layer from being prematurely cleared from the nasal cavity. This prior cushioning effect ensures that the therapeutic agent maintains sufficient residence time for effective delivery, reducing both dosage variability and waste.
3Duration of action of moving object
If hydrophobic or water-sensitive therapeutic agents are used, then solubility requirements are met, but retention time in nasal cavity is short and variable
Solution Approach 1:
The denser lower fluid acts as an intermediary medium that supports the upper therapeutic fluid layer containing hydrophobic or water-sensitive agents. This intermediary layer provides the necessary retention time extension without directly interacting with or dissolving the therapeutic agents, thereby maintaining their solubility requirements while extending retention time.
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 dual-density approach significantly increases the residence time of therapeutic agents in the nasal cavity, reduces waste, and enhances delivery precision by concentrating the therapeutic agent in the target area, minimizing disruption and off-target delivery.
Implementation Method 1
the lower fluid supports the upper fluid, for example, supporting the placement of the upper fluid in a desired region for a longer time
Implementation Method 2
The formulations may form two fluids which are immiscible at intranasal environmental conditions, with the upper, or lighter, of the fluids configured to administer a therapeutic dose
Data Source
AI summary
The present disclosure describes formulations, methods, and devices for intranasal delivery to a subject. The formulations may form two fluids which are immiscible at intranasal environmental conditions, such that when a formulation is delivered to a nasal cavity the two fluids separate with the more dense of the fluids settling below the less dense of the two fluids. One or more of the two fluids may concentrate a therapeutic agent or sampling fluid against a selected portion of the nasal cavity and the more dense of the two fluids can increase retention time of the formulation within the nasal cavity. Devices of the present disclosure may provide a convenient and effective way to deliver dual-density formulations intranasally.