Intranasal Botulinum Toxin Delivery via NALT-Targeted Applicator

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Current treatments for allergic rhinitis, such as intranasal injections of botulinum toxin, require specialized ENT instrumentation and expertise, are costly, and have limited duration of effect, making them impractical for widespread use by community-based practitioners and unaffordable for general patients.

Innovation Solution

A method for intranasal delivery of botulinum toxin formulations using sterile cotton-tipped applicators to target nasal-Associated Lymphoid Tissue (NALT) and Eustachian tube opening zone, combined with a penetration-enhancing mixture of medications and carrier excipients, allowing for reduced doses and increased absorption, administered by general practitioners in a simple, cost-effective manner.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If intranasal injections of botulinum toxin are used, then treatment effectiveness is improved, but device complexity and operational difficulty increase due to requiring specialized ENT instrumentation and expertise

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidspecialized ENT instrumentation
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent introduces a specialized nasal applicator as an intermediary device that delivers botulinum toxin via the nasal mucosa, eliminating the need for complex ENT instrumentation. The applicator serves as a mediator between the toxin and target tissue, enabling simple topical application while maintaining treatment effectiveness through the nasal-lymphoid route of delivery

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical injection system (needles, syringes, specialized ENT instruments) with a topical application system using a nasal applicator. This substitution eliminates complex mechanical instrumentation while achieving equivalent or superior therapeutic effects through mucosal absorption and lymphoid tissue targeting

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If high doses of botulinum toxin are administered, then treatment effectiveness is improved, but cost increases making it unaffordable for general patients

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidcost of medication
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent changes the delivery parameters by using a poloxamer gel formulation that enables reduced dosing. The gel matrix controls toxin release and enhances mucosal retention, allowing effective treatment with lower quantities of botulinum toxin compared to traditional injection methods, thereby reducing medication costs

Inventive Principle:
Principle #35Parameter changes

3Reliability

If intranasal injections are used, then treatment effect is achieved, but duration of action is limited requiring frequent treatments

Engineering Contradiction:
Improvetreatment effectVSAvoidduration of treatment effect
Core Design Contradiction:
ReliabilityVSDuration of action of moving object

Solution Approach 1:

The patent achieves continuous therapeutic action through the poloxamer gel formulation that provides sustained release of botulinum toxin from the nasal mucosa. The gel matrix maintains toxin presence at the target site over an extended period, ensuring continuous inhibition of mucus production and prolonged symptom relief without requiring frequent re-treatment

Inventive Principle:
Principle #20Continuity of useful action

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 method provides a prolonged treatment effect with reduced medication costs, enabling affordable and accessible treatment of allergic rhinitis by general practitioners, improving patient acceptance and reducing the economic burden.

Implementation Method 1

a penetration-enhancing mixture of medications and carrier excipients, allowing for reduced doses and increased absorption

Methodology Applied
Scientific EffectMucosal penetration: Permeation

Implementation Method 2

Botulinum toxin is capable of disabling adrenergic cells, including epithelial or goblet cells which are responsible for the majority of mucus production in the nasal cavity membrane

Methodology Applied
Scientific EffectBotulinum toxin mechanism: Enzyme

Data Source

PatentUS12465563B2Botulinum toxin formulations and methods for intranasal delivery thereof for the treatment of allergic rhinitis
Publication Date: 2025.11.11 BARBAGALLO FRANCESCO
  • US12465563B2 patent drawing

AI summary

A method for intranasal delivery of a formulation comprising Botulinum toxin for the treatment of allergic rhinitis involved impregnating an absorbent tip of an applicator with the formulation, the applicator having a rigid rod having the absorbent tip at a distal end thereof, and inserting the applicator straight into a nasal cavity of a patient beneath the lower turbinates to target the nasal- or nasopharynx-associated lymphoid tissue (NALT) and the eustachian tube opening zone of the nasopharynx within the nasal cavity with the absorbent tip.