Poloxamer-Protein Particles for Sustained Release

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Solution Overview

Problem

Protein delivery from PLGA microparticles faces challenges due to protein stability issues during formulation and release, leading to incomplete and unstable release profiles, with a common problem being the 'burst effect' and instability caused by moisture-induced aggregation and ionic interactions.

Innovation Solution

A method involving the precipitation of proteins with poloxamers to form poloxamer-protein particles, which are then encapsulated, allowing for a controlled and sustained release of proteins over 20 days without the need for stabilizing agents like albumin or trehalose, utilizing a s/o/w method or prilling, and using glycofurol as a water-miscible non-solvent to induce precipitation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of moving object

If protein is delivered from PLGA microparticles, then sustained release is achieved, but protein stability deteriorates due to moisture-induced aggregation and ionic interactions

Engineering Contradiction:
Improverelease durationVSAvoidprotein stability
Core Design Contradiction:
Duration of action of moving objectVSReliability

Solution Approach 1:

Poloxamer acts as an intermediary substance between the protein and PLGA polymer matrix. The poloxamer forms a protective complex with the protein during encapsulation, preventing direct contact between the protein and the hydrophobic PLGA matrix, thereby preventing aggregation and degradation while enabling sustained release over 20 days

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention uses a composite formulation consisting of PLGA polymer matrix combined with poloxamer surfactant. This composite material system provides both the sustained release capability of PLGA and the protein stabilization function of poloxamer, resolving the contradiction between release duration and protein stability

Inventive Principle:
Principle #40Composite materials

2Reliability

If stabilizing additives are used to minimize protein degradation, then protein stability improves, but release completeness deteriorates because stabilizers diffuse rapidly from microparticles

Engineering Contradiction:
Improveprotein stabilityVSAvoidrelease completeness
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The invention merges the stabilizing function with the release mechanism by forming a poloxamer-protein complex that is co-encapsulated within the PLGA matrix. This integrated approach ensures that the stabilizing poloxamer remains associated with the protein throughout the entire release period, preventing the rapid diffusion problem that plagues conventional stabilizer approaches and enabling complete release

Inventive Principle:
Principle #5Merging (Combining)

3Duration of action of moving object

If protein is encapsulated in PLGA microparticles, then sustained release is achieved, but burst effect occurs leading to incomplete release

Engineering Contradiction:
Improverelease durationVSAvoidrelease profile control
Core Design Contradiction:
Duration of action of moving objectVSManufacturing precision

Solution Approach 1:

Poloxamer serves as a mediating agent that modifies the interface between protein and PLGA matrix, creating a more uniform distribution and preventing the rapid initial release characteristic of burst effect. The poloxamer-protein complex integrates more smoothly into the polymer matrix, enabling controlled sustained release without the initial massive release that compromises completeness

Inventive Principle:
Principle #24Intermediary (Mediator)

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 complete and continuous release of proteins in a biologically active form, avoiding the burst effect and maintaining protein stability during the release period, with improved release profiles and high yields applicable to a wide range of proteins.

Implementation Method 1

when the protein was precipitated in the presence of a poloxamer, particles of protein/poloxamer were formed

Methodology Applied
Scientific EffectPrecipitation: Precipitation

Implementation Method 2

contacting the obtained solution with a water-miscible protein non sovent which is glycofurol, with a volume ratio of glycofurol/aqueous solution ranging from 5 to 100, to form a dispersion of poloxamer-protein particles

Methodology Applied
Scientific EffectNon-solvent induced precipitation: Precipitation

Implementation Method 3

As poloxamer is a surfactant, it is assumed that its presence limits the interactions between the protein and the polymer which encapsulates the protein

Methodology Applied
Scientific EffectSurfactant action: Surfactant

Data Source

PatentEP2203159B1Dispersion of poloxamer-protein particles, methods of manufacturing and uses thereof
Publication Date: 2024.03.13 INST NAT DE LA SANTE & DE LA RECHERCHE MEDICALE (INSERM)
  • EP2203159B1 patent drawingFigure 1
  • EP2203159B1 patent drawingFigure 2
  • EP2203159B1 patent drawingFigure 3

AI summary

The present invention relates to a method for preparing poloxamer-protein particles. It also relates to poloxamer-protein particles obtainable by this method, dispersion thereof, and their use in methods of encapsulation, in particular of microencapsulation.