Stabilizing Polypeptide for Botulinum Neurotoxin Formulation

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Solution Overview

Problem

There is a need for an alternative method to stabilize botulinum neurotoxin (BoNT) by inhibiting its diffusion in vivo, as existing methods do not effectively address this challenge.

Innovation Solution

A composition for stabilizing botulinum neurotoxin is developed, which includes a polypeptide represented by Formula 1. This polypeptide interacts with the cell membrane of nerve cells and inhibits the diffusion of BoNT, improving its stability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If botulinum neurotoxin is administered for therapeutic effect, then clinical efficacy is achieved, but unwanted diffusion occurs reducing precision and safety

Engineering Contradiction:

Improveclinical efficacyVSAvoidunwanted diffusion

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a stabilizing polypeptide as an intermediary substance that binds to the botulinum neurotoxin. This mediator prevents the toxin from diffusing to unintended sites while maintaining its therapeutic action at the target site, thus resolving the contradiction between achieving clinical efficacy and preventing unwanted diffusion.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent modifies the physical-chemical parameters of the botulinum neurotoxin by combining it with a stabilizing polypeptide. This changes the diffusion characteristics of the toxin, reducing its mobility and preventing spread to adjacent areas, thereby maintaining precision while preserving therapeutic effect.

Inventive Principle:

Principle #35Parameter changes

2Area of stationary object

If botulinum neurotoxin diffuses freely, then broader coverage is achieved, but duration of action decreases due to rapid clearance

Engineering Contradiction:

Improvecoverage areaVSAvoidduration of clinical efficacy

Core Design Contradiction:

Area of stationary objectVSDuration of action of moving object

Solution Approach 1:

The patent creates a localized concentration of the botulinum neurotoxin at the injection site by using the stabilizing polypeptide to restrict diffusion. This ensures the toxin remains concentrated where needed, providing both adequate coverage of the target area and prolonged duration of action by preventing rapid clearance.

Inventive Principle:

Principle #3Local quality

3Stability of the object's composition

If conventional stabilizing methods are used, then some stability is improved, but antigenicity increases causing immune responses

Engineering Contradiction:

Improvetoxin stabilityVSAvoidantigenicity

Core Design Contradiction:

Stability of the object's compositionVSObject-generated harmful factors

Solution Approach 1:

The patent changes the molecular parameters of the stabilizing agent by using a specifically designed polypeptide with particular amino acid sequences. This polypeptide provides stability to the botulinum neurotoxin through non-covalent interactions while its molecular characteristics are optimized to minimize immunogenicity, thus resolving the contradiction between stability and antigenicity.

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentEP4537850A1Composition for stabilizing botulinum neurotoxin, botulinum neurotoxin formulation containing same, and polypeptides for use therein

Publication Date: 2025.04.16 MEDY TOX INC

Figure 1(A)~1(B)
Figure 2(A)~2(B)
Figure 3(A)~3(B)

AI summary

Provided are a composition for stabilizing botulinum neurotoxin, a botulinum neurotoxin formulation including the same, and a polypeptide for use therein.