Allergen Pro-Toothpaste Formulation for Stable Oral Mucosal Delivery

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Solution Overview

Problem

Existing toothpaste formulations for oral mucosal immunotherapy (OMIT) face challenges in achieving consumer-acceptable stability, consistency, and texture while effectively delivering allergens, leading to low compliance and unsatisfactory treatment outcomes.

Innovation Solution

Formulating a pro-toothpaste composition with reduced vehicle volume and increased viscosity modifiers, such as sugar alcohols and silica-based thickeners, to create a stable and consumer-friendly toothpaste that can be combined with allergen solutions, ensuring homogeneous mixing and daily use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional toothpaste formulations are used for oral mucosal immunotherapy, then allergen delivery is achieved, but stability, consistency, and texture are compromised leading to low consumer acceptance

Engineering Contradiction:
Improveallergen delivery efficacyVSAvoidtoothpaste stability and consistency
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent modifies the physical and chemical parameters of the toothpaste formulation by adjusting the ratio of hydrophilic to hydrophobic components, optimizing viscosity, and controlling particle size distribution of the allergen. These parameter changes enable the formulation to maintain both allergen delivery efficacy and consumer-acceptable stability and consistency.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs composite material strategies by combining allergen particles with toothpaste base materials that have complementary properties. The formulation integrates hydrophilic and hydrophobic components, along with various excipients, to create a composite system that simultaneously achieves allergen stability, consistent texture, and consumer acceptance.

Inventive Principle:
Principle #40Composite materials

2Reliability

If allergen concentration is increased to improve treatment efficacy, then immunotherapy effectiveness improves, but formulation stability and consumer acceptance deteriorate

Engineering Contradiction:
Improveimmunotherapy effectivenessVSAvoidformulation stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent applies local quality by creating distinct micro-environments within the toothpaste formulation. Allergen particles are distributed throughout the matrix with localized concentrations optimized for immunotherapy effectiveness, while the surrounding toothpaste base maintains properties acceptable to consumers. This spatial differentiation allows high allergen concentration without compromising overall formulation stability.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent optimizes the concentration parameter of allergen within specific ranges that balance immunotherapy effectiveness with formulation stability. By carefully controlling allergen loading levels and adjusting related formulation parameters simultaneously, the patent achieves both high treatment efficacy and consumer-acceptable product stability.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If allergen delivery is integrated into daily toothbrushing routines to enhance compliance, then treatment adherence improves, but formulation requirements become more stringent

Engineering Contradiction:
Improvecompliance with treatment regimenVSAvoidformulation complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent makes the toothpaste formulation multi-functional by combining allergen delivery capabilities with standard toothpaste functions (cleaning, flavor, texture). This universal formulation allows the product to serve both as a therapeutic agent and a consumer-friendly oral care product, enhancing compliance without requiring separate treatment devices or complex administration procedures.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent enables self-service by incorporating allergen delivery directly into the routine toothbrushing activity. The formulation is designed to release allergens during normal brushing without requiring additional steps, devices, or professional administration. This self-service approach simplifies the treatment regimen and improves compliance while managing formulation complexity through integrated design.

Inventive Principle:
Principle #25Self-service

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 formulation maintains allergen stability and consumer acceptance, enhancing compliance by integrating allergen delivery into daily toothbrushing routines, thereby improving the efficacy of oral mucosal immunotherapy.

Implementation Method 1

increased viscosity modifiers, such as sugar alcohols and silica-based thickeners

Methodology Applied
Scientific EffectViscosity modification:

Implementation Method 2

sugar alcohols and silica-based thickeners

Methodology Applied
Scientific EffectHumectant action:

Implementation Method 3

ensuring homogeneous mixing

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 4

ensuring homogeneous mixing

Methodology Applied
Scientific EffectConvection: Convection

Data Source

PatentUS12527861B2Toothpaste for delivery of allergens to oral mucosa
Publication Date: 2026.01.20 ALLOVATE LLC
  • US12527861B2 patent drawing
  • US12527861B2 patent drawing

AI summary

Pro-toothpaste compositions formulated to receive a volume of allergen solution to provide toothpastes that exhibit efficacy for oral mucosal immunotherapy (OMIT) and acceptable consumer and product stability properties, along with kits of pro-toothpaste, allergen/extracts of allergens, and optionally compounding means and/or specialized toothbrushes are provided. Toothpastes suitable and effective for OMIT and methods for managing allergic symptoms and for reducing risk of allergy in people without symptoms employing the pro-toothpastes, toothpastes, and kits of the invention are also disclosed.