Lipid Particle Cooling Profile for Stable Drug Encapsulation
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Solution Overview
Problem
Existing methods for manufacturing lipid particles result in suboptimal delivery efficiency due to issues with inclusion amount, inclusion rate, and particle size variability, which affect the quality and effectiveness of substance delivery into cells.
Innovation Solution
A method involving controlled cooling of lipid particles at a rate of less than or equal to 1°C per minute, combined with specific lipid compositions and optional condensation and concentration steps, to enhance the quality and stability of lipid particles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional manufacturing methods are used, then production efficiency is maintained, but lipid particle quality and drug inclusion rates are insufficient
Solution Approach 1:
The patent applies parameter changes by precisely controlling the cooling rate (0.1-10°C per minute) and temperature ranges during lipid particle formation. This controlled thermal parameter transformation enables consistent high-quality particles with improved drug inclusion rates while maintaining scalable production processes.
Solution Approach 2:
The patent utilizes phase transitions of lipids during controlled cooling to form uniform particle structures. By managing the temperature-dependent phase changes of lipid components, the process achieves consistent particle morphology and size distribution, improving manufacturing precision without sacrificing productivity.
2Quantity of substance
If high drug inclusion rates are achieved, then delivery efficiency improves, but particle aggregation and leakage increase
Solution Approach 1:
The patent controls drug inclusion rates and particle stability through precise parameter management during cooling. By optimizing temperature profiles and cooling rates, the process achieves high drug incorporation while preventing aggregation and maintaining particle integrity, resolving the contradiction between quantity and stability.
3Productivity
If rapid manufacturing is used, then productivity increases, but manufacturing precision and particle quality decrease
Solution Approach 1:
The patent enables rapid manufacturing with high precision by optimizing the cooling rate parameters within the 0.1-10°C per minute range. This parameter optimization allows the process to achieve both speed and quality by identifying the optimal window where rapid cooling does not compromise particle uniformity or drug inclusion.
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 method produces lipid particles with improved inclusion efficiency, reduced leakage, and consistent size, enhancing the delivery of substances into cells and reducing cell toxicity.
Implementation Method 1
cooling a solution containing the lipid particle including the drug at a rate of less than or equal to 1° C. per minute
Data Source
AI summary
According to one embodiment, a method for manufacturing a lipid particle including a drug, the method includes cooling a solution containing the lipid particle including the drug at a rate of less than or equal to 1° C. per minute.