Microparticle Purification via Non-Solvent Extraction

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Solution Overview

Problem

Existing methods for processing microparticles often result in residual polymers, solvents, and excipients, limiting the production of microparticles that are 100% active agents or macromolecule carriers free from these contaminants, and complicating manufacturing efficiencies.

Innovation Solution

The method involves using a non-solvent, such as 2-methyl-2-propanol, to separate microparticles from reaction media, allowing for the removal of non-volatile materials more soluble in the solvent than the microparticles, thereby achieving microparticles that are substantially free of residual polymers and solvents, and facilitating multi-phasic dispersion processing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If conventional methods are used to process microparticles, then manufacturing process is simpler, but residual polymers, solvents, and excipients remain in the microparticles

Engineering Contradiction:
Improvepurity of microparticlesVSAvoidcomplexity of processing method
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent introduces a non-solvent as an intermediary substance to selectively remove residual polymers, solvents, and excipients from microparticles. This non-solvent acts as a mediator that interacts with the contaminants while leaving the microparticles intact, enabling high-purity production without complex processing equipment.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the chemical parameter of the processing medium by using a non-solvent system with specific solubility characteristics. By adjusting the solubility parameters of the non-solvent to be higher than those of the microparticle materials, the method achieves selective removal of contaminants while maintaining microparticle integrity.

Inventive Principle:
Principle #35Parameter changes

2Quantity of substance

If conventional processing methods are used, then manufacturing process is less complex, but microparticles cannot achieve 100% active agents or macromolecule carriers

Engineering Contradiction:
Improveconcentration of active agentsVSAvoidpurity of microparticles
Core Design Contradiction:
Quantity of substanceVSManufacturing precision

Solution Approach 1:

The patent extracts residual polymers, solvents, and excipients from the microparticle system using a non-solvent. This extraction process selectively removes contaminants while preserving the active agents and macromolecule carriers, enabling the achievement of 100% active agent content in the final microparticle product.

Inventive Principle:
Principle #2Taking out (Extraction)

3Productivity

If conventional methods are used, then processing steps are fewer, but manufacturing efficiency is reduced

Engineering Contradiction:
Improvemanufacturing efficiencyVSAvoidprocessing time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The patent implements a continuous processing approach where the non-solvent is continuously circulated through the microparticle suspension, allowing simultaneous removal of multiple contaminant types in a single operational sequence. This continuous action maintains high manufacturing efficiency while reducing overall processing time compared to multiple sequential steps.

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

This approach enables the production of microparticles with enhanced purity and manufacturing efficiency, allowing for increased concentrations of active agents and macromolecule carriers, and reduces residual material content, improving their application in drug delivery, diagnostics, and separations.

Implementation Method 1

the non-volatile material is more soluble in the non-solvent than are the microparticles

Methodology Applied
Scientific EffectDifferential solubility: Solvation

Implementation Method 2

exposing the composition to the non-solvent to form a mixture containing one or more liquid phases and the solid microparticles

Methodology Applied
Scientific EffectPhase separation: Phase Change

Data Source

PatentUS8323685B2Methods of processing compositions containing microparticles
Publication Date: 2012.12.04 BAXTER INT INC

AI summary

Methods for processing microparticles involve providing a composition comprising a plurality of solid microparticles and at least one non-volatile material, providing a non-solvent, and exposing the composition to the non-solvent to remove at least a portion of the non-volatile material from the composition while retaining at least the microparticles.