Bio-fermented Sodium Hyaluronate Polymer Matrix Stability

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Solution Overview

Problem

Current sodium hyaluronate polymer matrix formulations face challenges in maintaining high concentrations due to instability, leading to reduced effectiveness in wound healing and drug delivery, and are limited by the use of animal-derived sources that can cause allergies and disease transmission.

Innovation Solution

Development of stable polymer matrix compositions using bio-fermented sodium hyaluronate from bacterial sources like Streptococcus zooepidemicus or Bacillus subtilis, combined with non-ionic polymers, methylparaben, and polyethylene glycol, ensuring a concentration range of 1.5% to 3.5% w/w and improved stability and safety.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If sodium hyaluronate is obtained from animal sources (rooster combs), then formulations can be manufactured, but they cause allergies and carry risks of transmitting animal diseases to humans

Engineering Contradiction:
Improvemanufacturability of sodium hyaluronate formulationsVSAvoidallergies and disease transmission risks
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the harmful animal-derived components and replaces them with bio-fermented sodium hyaluronate produced through bacterial fermentation processes, eliminating allergy and disease transmission risks while maintaining the therapeutic benefits of sodium hyaluronate in polymer matrix formulations

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the source parameter of sodium hyaluronate from animal origin to bacterial fermentation origin, fundamentally altering the biological source while preserving the functional properties of sodium hyaluronate in wound healing and drug delivery applications

Inventive Principle:
Principle #35Parameter changes

2Quantity of substance

If sodium hyaluronate concentration is increased above 1.5% w/w, then therapeutic effectiveness is improved, but formulation stability deteriorates and viscosity becomes too high for normal use

Engineering Contradiction:
Improvesodium hyaluronate concentrationVSAvoidformulation stability
Core Design Contradiction:
Quantity of substanceVSStability of the object's composition

Solution Approach 1:

The patent creates a composite polymer matrix system combining sodium hyaluronate with other compatible polymers and excipients that work synergistically to maintain formulation stability at high sodium hyaluronate concentrations (1.5-3.5% w/w) while controlling viscosity for practical application

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent optimizes multiple formulation parameters including pH, ionic strength, and polymer ratios to enable stable high-concentration sodium hyaluronate formulations that maintain appropriate viscosity and stability characteristics

Inventive Principle:
Principle #35Parameter changes

3Quantity of substance

If sodium hyaluronate concentration is increased above 1.5% w/w, then therapeutic effectiveness is improved, but viscosity becomes too high for normal use in tube packaging

Engineering Contradiction:
Improvesodium hyaluronate concentrationVSAvoidapplicability and packaging usability
Core Design Contradiction:
Quantity of substanceVSEase of operation

Solution Approach 1:

The patent develops a composite formulation system that balances high sodium hyaluronate concentration with other polymers and viscosity-modifying agents to achieve a product that is both therapeutically effective and easy to apply from tube packaging

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent adjusts formulation parameters including polymer molecular weight, concentration ratios, and pH to optimize the viscosity profile, ensuring the product remains pumpable and applicable despite high active ingredient content

Inventive Principle:
Principle #35Parameter changes

4Productivity

If high concentration sodium hyaluronate formulations are not manufactured properly, then formulation can be produced initially, but they quickly break down resulting in very short shelf life

Engineering Contradiction:
Improveinitial formulation productionVSAvoidshelf life
Core Design Contradiction:
ProductivityVSDuration of action of stationary object

Solution Approach 1:

The patent implements preliminary stabilization measures during manufacturing including controlled mixing sequences, pH adjustment, and incorporation of stabilizing excipients that prevent subsequent degradation and extend shelf life of high-concentration formulations

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent incorporates stabilizing agents and optimizes formulation composition beforehand to cushion against degradation mechanisms, ensuring long-term stability and preventing breakdown during storage

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

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 bio-fermented sodium hyaluronate polymer matrix compositions demonstrate enhanced stability, reduced cytotoxicity, and improved wound-healing properties, maintaining effective sodium hyaluronate levels over time, and ensuring safer, more effective topical and transdermal delivery of active ingredients.

Implementation Method 1

Fractions of HA, including its sodium salt, are known to form a stable polymer matrix when combined with a non-ionic polymer such as hydroxyethyl cellulose or hydroxypropyl cellulose

Methodology Applied
Scientific EffectPolymer matrix formation:

Implementation Method 2

a sodium hyaluronate polymer matrix formulation helps to maintain a moist wound environment

Methodology Applied
Scientific EffectWater retention: Absorption (physical)

Data Source

PatentUS10322142B2Polymer matrix compositions comprising a high concentration of bio-fermented sodium hyaluronate and uses thereof
Publication Date: 2019.06.18 GLYCOBIOSCI
  • US10322142B2 patent drawing

AI summary

The present invention relates to stable polymer matrix compositions comprising high concentrations (from about 1.5% w/w to about 3.5% w/w) sodium hyaluronate obtained from a Streptococcus zooepidemicus source and a non-ionic polymer. The polymer matrix composition further comprises polyethylene glycol and methylparaben, and utilizes ingredients that are of pharmaceutical or compendial grade. The polymer matrix compositions may optionally comprise an active ingredient. The present polymer matrix compositions may be used in the treatment of wounds, burns, certain dermatological conditions, vaginal dryness, and in topical, transdermal delivery and sustained release of active ingredients.