Concentrated Valproic Acid for Rapid Emergency Delivery

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Solution Overview

Problem

Current treatments for traumatic brain injury (TBI) and emergency injuries are largely supportive and do not effectively improve survival or reduce brain damage, with existing valproic acid formulations requiring multiple vials and lengthy infusion times, posing challenges in rapid and effective high-dose delivery, especially in field settings where time is critical and bacterial contamination risks are high.

Innovation Solution

Development of concentrated valproic acid pharmaceutical compositions for rapid delivery via intraosseous or intravenous routes, providing high doses (up to 150 mg/kg) within a short time frame (e.g., 2-3 hours) using formulations with concentrations of 100 mg/ml to 500 mg/ml, ensuring stability at room temperature and reducing the need for multiple vials, thus minimizing preparation time and contamination risks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional valproic acid formulations are used, then multiple vials and lengthy infusion times are required, but this increases preparation time and bacterial contamination risks

Engineering Contradiction:
Improvereduction of contamination riskVSAvoidpreparation time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent combines multiple vials of conventional valproic acid formulation into a single concentrated formulation containing the equivalent dose, eliminating the need for multiple connections and reducing preparation time while minimizing contamination risk

Inventive Principle:
Principle #5Merging (Combining)

2Productivity

If concentrated valproic acid formulations are used, then rapid delivery of high doses is achieved, but formulation stability and safety must be maintained

Engineering Contradiction:
Improvedelivery speedVSAvoidformulation stability
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent changes the concentration parameter of valproic acid from conventional levels to highly concentrated formulations (containing pharmacologically effective amounts in single-dose volumes), enabling rapid delivery while maintaining stability through controlled formulation conditions

Inventive Principle:
Principle #35Parameter changes

3Reliability

If high doses of valproic acid are administered rapidly, then survival improvement and brain damage reduction are achieved, but the complexity of formulation and administration increases

Engineering Contradiction:
Improvesurvival improvementVSAvoidformulation complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent segments the administration process into a single-dose concentrated formulation that can be delivered through standard intravenous or intraosseous routes, maintaining simplicity despite the high dose requirement

Inventive Principle:
Principle #1Segmentation

Data Source

PatentUS20230069590A1Concentrated sodium valproate for rapid delivery
Publication Date: 2023.03.02 THE RGT UNIV OF MICHIGAN
  • US20230069590A1 patent drawing
  • US20230069590A1 patent drawing
  • US20230069590A1 patent drawing

AI summary

Provided herein are pharmaceutical compositions comprising concentrated valproic acid (e.g., >200 mg/mL) for rapid delivery of high doses (e.g., 100-200 mg/kg) of valproic acid to subjects (e.g., intraosseous, intravenous, etc.), and methods of treating emergency injuries and conditions therewith.