Viscoelastic Glycated Chitosan Polymer for Injectable Therapeutics

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Solution Overview

Problem

Conventional glycated chitosan preparations are difficult to inject or dispense in biomedical applications due to their viscosity issues and are not suitable for industrial manufacturing according to Current Good Manufacturing Practices (cGMP), making them unsuitable for human use.

Innovation Solution

Development of a viscoelastic glycated chitosan polymer with a specific molecular weight range and degree of glycation, formulated as a sterile filtered aqueous mixture with controlled viscosity, enabling improved injectability and sterile filtration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional glycated chitosan preparations are used, then immunoadjuvant efficacy is achieved, but injectability and ease of administration deteriorate due to high viscosity

Engineering Contradiction:
Improveimmunoadjuvant efficacyVSAvoidinjectability
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent applies parameter changes by modifying the molecular weight of glycated chitosan to a specific range (100 kDa to 1000 kDa, preferably 200-500 kDa) and controlling the degree of glycation (10-30% of free amino groups). These parameter adjustments reduce viscosity while preserving immunoadjuvant efficacy, enabling proper injectability and administration.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If conventional glycated chitosan preparations are used, then therapeutic effect is achieved, but manufacturing feasibility deteriorates due to inability to sterile filter

Engineering Contradiction:
Improvetherapeutic effectVSAvoidmanufacturing feasibility
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent resolves the manufacturing feasibility issue by changing the molecular weight parameter to 100-1000 kDa and controlling glycation degree at 10-30%. These modifications reduce the polymer's resistance to filtration, enabling sterile filtration through standard 0.22 µm filters while maintaining therapeutic efficacy and allowing cGMP compliance.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If conventional glycated chitosan preparations are used, then immunostimulant activity is achieved, but pain during administration increases

Engineering Contradiction:
Improveimmunostimulant activityVSAvoidpain during administration
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent reduces pain during administration by adjusting the molecular weight to 100-1000 kDa and glycation degree to 10-30%. These parameter changes produce a formulation with optimized viscosity and rheological properties, reducing mechanical irritation and injection pain while preserving immunostimulant activity.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS11111316B2Chitosan-derived compositions
Publication Date: 2021.09.07 IMMUNOPHOTONICS INC
  • US11111316B2 patent drawing
  • US11111316B2 patent drawing
  • US11111316B2 patent drawing

AI summary

The present invention relates generally to therapeutic compositions comprising chitosan-derived compositions used in connection with methods for treating neoplasms, such as for instance, malignant lung, thyroid and kidney neoplasms, and other types of malignant neoplasms, and other medical disorders.