Non-Ionic Nanoemulsion Adjuvant for Nasal Mucosa

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Solution Overview

Problem

Existing mucosal adjuvants face challenges in inducing immune responses without increasing metabolic burden and achieving stable, small particle sizes, as they often rely on ionic emulsifiers that can cause adverse reactions and have insufficient stability.

Innovation Solution

A nanoemulsion adjuvant is developed without ionic emulsifiers, using a non-ionic emulsifier system to create a stable, nanoscale lipid particle distribution between 20-200 nanometers, enhancing immune responses through nasal mucosa administration without adverse effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If ionic emulsifiers are used to prepare emulsion adjuvants, then the emulsion can be formed and administered through nasal mucosa, but the metabolic burden on the human body increases and adverse reactions may occur

Engineering Contradiction:
Improveimmune response inductionVSAvoidmetabolic burden and adverse reactions
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the chemical nature of the emulsifier from ionic to non-ionic, fundamentally altering the parameter of emulsifier charge. This parameter change eliminates the metabolic burden and adverse reactions associated with ionic emulsifiers while maintaining emulsion formation and immune response induction capabilities through the nasal mucosa route

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs non-ionic emulsifiers that are metabolizable and do not accumulate in the body, effectively treating them as temporary, disposable components that perform their emulsification function and then are safely eliminated, reducing long-term metabolic burden

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Object-affected harmful factors

If non-ionic emulsifiers are used to create small particle size emulsions, then metabolic burden is reduced, but the stability of the emulsion system becomes insufficient

Engineering Contradiction:
Improvemetabolic burdenVSAvoidemulsion stability
Core Design Contradiction:
Object-affected harmful factorsVSStability of the object's composition

Solution Approach 1:

The patent uses composite non-ionic emulsifier systems combining multiple non-ionic emulsifiers with different hydrophilic-lipophilic balance (HLB) values. This composite approach compensates for the individual limitations of each non-ionic emulsifier, achieving both small particle size and enhanced emulsion stability simultaneously

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent optimizes the local properties of the emulsion by carefully selecting non-ionic emulsifiers with specific HLB values suited for different regions of the emulsion system, creating local stability zones that collectively maintain overall emulsion integrity and prevent aggregation

Inventive Principle:
Principle #3Local quality

3Reliability

If emulsion particle size is reduced to nanoscale, then immune response is enhanced and drug delivery is improved, but the preparation difficulty and stability challenges increase

Engineering Contradiction:
Improveimmune response and drug delivery efficiencyVSAvoidpreparation complexity and stability control
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent employs preliminary action by pre-forming small-sized emulsion droplets under controlled conditions before final administration. The emulsion is prepared with optimized non-ionic emulsifier concentrations and subjected to controlled homogenization to pre-establish the nanoscale particle size distribution, ensuring stability and immune responsiveness without requiring complex post-preparation modifications

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent utilizes parameter changes by optimizing the HLB values and concentrations of non-ionic emulsifiers to achieve and maintain nanoscale particle sizes. By adjusting these parameters, the emulsion achieves the optimal balance between small particle size for enhanced immune response and sufficient stability for practical application

Inventive Principle:
Principle #35Parameter changes

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 nanoemulsion adjuvant effectively induces immune responses with high antigen delivery efficiency and stability, reducing metabolic burden and improving drug delivery, as demonstrated by enhanced immune titers and immune cell activation in animal models.

Implementation Method 1

an emulsion system for stabilizing the continuous aqueous and oil phase interfaces and consisting of a non-ionic emulsifier

Methodology Applied
Scientific EffectSurface tension: Surface Tension

Implementation Method 2

a nanoemulsion adjuvant... composed of a continuous aqueous phase containing H2O molecules, an oil phase containing metabolizable oil

Methodology Applied
Scientific EffectEmulsion: Emulsion

Data Source

PatentUS11160862B2Nanoemulsion adjuvant for nasal mucosa and preparation method thereof
Publication Date: 2021.11.02 NATIONAL HEALTH RESEARCH INSTITUTE
  • US11160862B2 patent drawing
  • US11160862B2 patent drawing
  • US11160862B2 patent drawing

AI summary

The invention provides a nanoemulsion adjuvant and a preparation method thereof, which are composed of the following components: a continuous aqueous phase containing H2O molecules, an oil phase material containing fats and oils, and an emulsion system for stabilizing the interface between the continuous aqueous phase and the oil phase, and the emulsion system is an emulsifier mixture. The adjuvant is characterized in that the emulsion system does not contain an ionic emulsifier and the particle size of the emulsion is between 20 and 200 nanometers. The use of the nanoemulsion adjuvant can prevent toxicity and possible harm of ionic emulsifiers to human cells, and provide a vaccine preparation capable of eliciting a high degree of immune response.