Gas-Filled Microvesicle Formulation for Extended Bolus Intervals
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Solution Overview
Problem
Existing therapeutic treatments using gas-filled microvesicles require frequent and complex administration methods, such as infusion or short-interval boluses, which are costly and time-consuming, and there is a need for a more efficient and sustained administration method that maintains therapeutic effectiveness.
Innovation Solution
A suspension of gas-filled microvesicles comprising fatty acid di-ester of phosphatidylcholine, pegylated phosphatidylethanolamine, and fatty acid, preferably DSPC, DPPE-MPEG5000, and palmitic acid, is administered as subsequent boluses at intervals of at least four minutes to fifteen minutes, maintaining therapeutic effectiveness while reducing the total amount of microvesicles needed.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If gas-filled microvesicles are administered as frequent boluses to maintain therapeutic effectiveness, then therapeutic efficacy is improved, but total amount of microvesicles required increases and treatment complexity increases
Solution Approach 1:
The patent changes the physical-chemical parameters of the microvesicle formulation, specifically using a freeze-dried composition with specific phospholipid ratios and gas composition that enables extended circulation time and sustained therapeutic effect, allowing longer intervals between administrations
Solution Approach 2:
The microvesicles are prepared in advance as a freeze-dried composition that can be stored and then reconstituted before use, allowing the therapeutic agent to be ready for administration without requiring complex on-site preparation during the treatment period
2Reliability
If gas-filled microvesicles are administered as continuous infusion to maintain therapeutic effectiveness, then therapeutic efficacy is improved, but device complexity and operational complexity increase
Solution Approach 1:
Instead of continuous infusion, the patent employs periodic bolus administrations at extended intervals (at least 4 minutes apart) using simple syringe and catheter, achieving sustained therapeutic effect through strategically timed discrete doses rather than continuous delivery
Solution Approach 2:
The patent extracts the need for complex infusion devices by formulating the microvesicles with extended circulation properties that allow simple bolus administrations to achieve the same therapeutic effect as complex continuous infusions
3Reliability
If gas-filled microvesicles are administered as continuous infusion to maintain therapeutic effectiveness, then therapeutic efficacy is improved, but preparation time and operator presence time increase
Solution Approach 1:
The microvesicles are freeze-dried and prepared in advance, allowing the formulation to be stored ready-to-use and simply reconstituted before administration, eliminating the need for lengthy on-site preparation and reducing operator presence requirements during treatment
Solution Approach 2:
The extended interval between bolus administrations reduces the frequency of operator interventions and monitoring, allowing treatment to proceed with minimal operator presence while maintaining therapeutic effectiveness
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 formulation allows for longer administration intervals between boluses, reducing the total amount of microvesicles required and minimizing the number of administrations while maintaining therapeutic efficacy, particularly in treatments involving ultrasound.
Implementation Method 1
filled with a physiologically acceptable gas substantially insoluble in water, preferably a perfluorinated hydrocarbon
Data Source
Figure 1~2
AI summary
Use of a suspension of gas-filled microbubbles comprising a fatty acids di-ester of phosphatidylcholine (PC), a pegylated phosphatidylethanolamines (PE-PEG) and a fatty acid in a therapeutic method, wherein said suspension is administered as subsequent boluses.