Lyophilized Embolic Microspheres Vacuum Packaging
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Freeze-dried embolic microspheres often develop air pockets during the drying process, leading to slow rehydration, buoyancy issues, and ineffective suspension, which hinder their delivery and stability during embolization procedures.
Innovation Solution
A method involving a freezing step followed by lyophilization under reduced pressure, with subsequent packaging under vacuum, ensures spherical particles that rehydrate efficiently and maintain stability, avoiding the need for additional excipients.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If freeze-drying is performed to remove water from embolic microspheres, then storage stability is improved, but air pockets form within the microspheres causing slow rehydration and buoyancy issues
Solution Approach 1:
The patent applies parameter changes by controlling the freezing temperature and pressure conditions during lyophilization to prevent air pocket formation. By optimizing these parameters, the microspheres maintain their structural integrity and rehydration capability while achieving storage stability.
Solution Approach 2:
The patent utilizes phase transitions during the freeze-drying process, specifically the transition of water from liquid to solid (freezing) and then from solid to vapor (sublimation under reduced pressure). This controlled phase transition removes water without creating air pockets that would hinder rehydration.
2Stability of the object's composition
If freeze-drying is performed to remove water from embolic microspheres, then storage stability is improved, but the microspheres float during rehydration affecting suspension quality
Solution Approach 1:
The patent controls freezing and drying parameters to preserve the density characteristics of microspheres. By maintaining appropriate porosity and structural integrity through parameter optimization, the microspheres achieve both storage stability and proper sinking behavior during rehydration, ensuring reliable suspension quality.
3Ease of manufacture
If air pockets are present in dried microspheres, then storage is simplified, but rehydration is inhibited and delivery through micro-catheter is compromised
Solution Approach 1:
The patent employs controlled phase transitions during freeze-drying to remove water without trapping air pockets. The sublimation process under reduced pressure allows water to transition directly from solid to vapor, leaving a porous but air-free structure that maintains both ease of storage and effectiveness in delivery through micro-catheters.
4Stability of the object's composition
If rehydration is slowed by air pockets, then storage stability is maintained, but procedural time increases and handling becomes difficult
Solution Approach 1:
The patent optimizes freezing and drying parameters to create microspheres with controlled porosity that facilitates rapid rehydration. By adjusting these parameters, the microspheres achieve a balance between storage stability and quick rehydration, reducing procedural time without compromising storage characteristics.
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 enhances the rehydration speed and suspension homogeneity of embolic agents, facilitating controlled delivery and improved handling during medical procedures.
Implementation Method 1
a freezing step in which particles of polymer matrix swollen with water and having absorbed therein a non-volatile biologically active compound are cooled to a temperature below the freezing point for water
Implementation Method 2
a lyophilisation step in which the cooled particles from step i) are subjected to a reduced pressure at which ice sublimes for a period during which at least a portion of the absorbed ice sublimes and water vapour is removed
Implementation Method 3
the packaging step is carried out under reduced pressure and the package containing the particles is substantially airtight and has an interior under vacuum
Data Source
Figure 1A~1E
AI summary
A pharmaceutical product comprising lyophilised polymer matrix including a biologically active compound, of particular utility for embolisation, having improved rehydration properties is packaged in an airtight package under vacuum.