Pharmaceutical Prepolymer Foam Manufacturing via Organic Solvent Integration

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Solution Overview

Problem

Conventional methods for manufacturing pharmaceutical active foam wound dressings often result in inhomogeneous distribution of active ingredients, loss of antimicrobial efficiency due to water exposure, and inability to integrate moisture-sensitive agents, posing risks to workers and affecting foam properties.

Innovation Solution

A method involving the integration of a dry pharmaceutical active agent into a prepolymer formulation with controlled moisture content, using toluene di-isocyanate and aliphatic di-isocyanate compounds, which are then polymerized with polyols to form a stable prepolymer that can be stored and foamed later, reducing exposure to chemicals and maintaining agent efficiency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If pharmaceutical active agents are added to an aqueous phase with continuous agitation, then the active ingredients are dispersed in the foam, but the distribution becomes inhomogeneous and the pharmaceutical efficiency is lost due to water exposure

Engineering Contradiction:
Improvedistribution of active ingredientVSAvoidpharmaceutical efficiency
Core Design Contradiction:
Quantity of substanceVSReliability

Solution Approach 1:

The invention extracts the harmful element (water) from the system by using an organic solvent instead of an aqueous phase to dissolve the pharmaceutical active agent. This eliminates the water-induced loss of pharmaceutical efficiency while maintaining homogeneous distribution through proper agitation of the organic solution with the prepolymer mixture.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention changes the chemical parameter of the solvent from water-based to organic-based. By using an organic solvent, the pharmaceutical active agent maintains its efficiency while being properly distributed in the foam matrix, resolving the contradiction between distribution quality and pharmaceutical reliability.

Inventive Principle:
Principle #35Parameter changes

2Productivity

If conventional dynamic mixers are used to mix prepolymer with water and surfactant, then the foam can be produced, but the pharmaceutical active ingredient distribution becomes inhomogeneous

Engineering Contradiction:
Improvefoam productionVSAvoidhomogeneity of active ingredient
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The invention applies preliminary action by pre-dissolving the pharmaceutical active agent in the organic solvent before mixing with the prepolymer. This pre-preparation ensures that the active ingredient is already in a homogeneous state, eliminating the distribution problems that occur during the foaming process itself.

Inventive Principle:
Principle #10Preliminary action

3Ease of operation

If silver-containing antimicrobial compounds are exposed to water, then they can be dispersed in the foam, but their efficiency is significantly reduced due to silver ion release

Engineering Contradiction:
Improvedispersion in foamVSAvoidantimicrobial efficiency
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The invention converts the harmful effect of water exposure (silver ion release) into a beneficial approach by using an organic solvent system. This alternative approach achieves dispersion of the antimicrobial compound while preventing the harmful silver ion release, thereby maintaining antimicrobial efficiency.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

4Productivity

If known manufacturing methods are used, then foam can be produced, but moisture sensitive active ingredients cannot be integrated

Engineering Contradiction:
Improvefoam manufacturingVSAvoidintegration of moisture sensitive agents
Core Design Contradiction:
ProductivityVSAdaptability or versatility

Solution Approach 1:

The invention changes the moisture parameter of the system by replacing water with an organic solvent. This parameter change enables the integration of moisture-sensitive active ingredients into the foam while maintaining normal foam manufacturing productivity, as the organic solvent does not cause premature reaction or degradation of moisture-sensitive compounds.

Inventive Principle:
Principle #35Parameter changes

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

This method ensures homogeneous distribution and preserved efficiency of pharmaceutical agents, reduces chemical exposure, and maintains foam structure and absorption properties, providing consistent antimicrobial release in wound dressings.

Implementation Method 1

the at least one polyol compound and the di-isocyanate compounds are allowed to polymerize into a precursor for subsequent polymerization

Methodology Applied
Scientific EffectPolymerization: Chemical Bonding

Implementation Method 2

When water is added to the pharmaceutical active prepolymer formulation the polymerization process reassumes under development of CO 2 , to create stable foam

Methodology Applied
Scientific EffectCO2 generation through polymerization: Chemical Bonding

Data Source

PatentEP3413932B1A method of manufacturing a pharmaceutical active prepolymer formulation, formulations obtained by the method and uses of the formulation
Publication Date: 2020.03.25 PHARMAPLAST SAE

AI summary

A method of manufacturing a pharmaceutical active prepolymer formulation includes the steps of combining in a reactor at least one polyol compound, at least one aromatic di-isocyanate compound, and/or at least one aliphatic di-isocyanate compound, and a pharmaceutical active agent having a water or moisture content of maximum 1.0 wt/wt%. Then the at least one polyol compound and/or the at least one di-isocyanate compound is allowed to prepolymerize to integrate the pharmaceutical active agent to obtain the pharmaceutical active prepolymer formulation. The pharmaceutical active prepolymer formulation can be made into a foam for use in pharmaceutical active wound dressings.