Enzymatic Purification of PHB-co-HV for Therapeutic Formulations

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Solution Overview

Problem

Current methods for producing optically active (R)-3-hydroxybutyrate and (R)-3-hydroxyvalerate mixtures are inefficient and costly, often requiring high-purity polyhydroxybutyrate-co-hydroxyvalerate (PHB-co-HV) as raw material, which involves complex purification processes and can result in contamination or low yields, limiting their use in nutritional supplements.

Innovation Solution

A low-cost enzymatic process for purifying PHB-co-HV prior to esterification, allowing for the production of high-purity (R)-3-hydroxybutyrate and (R)-3-hydroxyvalerate mixtures that can be used in nutritional formulations, addressing the inefficiencies and contamination issues of previous methods.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If complex purification processes are used to obtain high-purity PHB-co-HV, then product purity is improved, but device complexity and manufacturing cost increase

Engineering Contradiction:
Improveproduct purityVSAvoidpurification process complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent extracts and removes impurities from PHB-co-HV through a simplified purification process that selectively eliminates contaminants while retaining the desired polymer. This approach achieves high purity without requiring multiple complex purification steps, directly resolving the contradiction between product purity and process complexity.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces an intermediary purification step that uses specific solvents or reagents to facilitate the separation of impurities from PHB-co-HV. This intermediary mechanism enables effective purification with simpler equipment and fewer stages compared to conventional direct purification methods.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If conventional production methods are used, then existing processes can be maintained, but productivity and cost-effectiveness deteriorate

Engineering Contradiction:
Improveproduction efficiencyVSAvoidmanufacturing cost
Core Design Contradiction:
ProductivityVSEase of manufacture

Solution Approach 1:

The patent modifies key process parameters including temperature, pressure, solvent selection, and reaction time to optimize the production of (R)-3-hydroxybutyrate and (R)-3-hydroxyvalerate. These parameter changes increase reaction efficiency and yield while reducing energy consumption and operational costs, thereby improving both productivity and ease of manufacture.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent replaces complex mechanical purification systems with chemical or enzymatic methods that achieve separation and purification through molecular interactions. This substitution reduces equipment complexity and operational costs while maintaining or improving production efficiency.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Manufacturing precision

If high-purity PHB-co-HV is used as raw material, then final product purity is improved, but loss of substance increases due to purification requirements

Engineering Contradiction:
Improvefinal product purityVSAvoidmaterial loss during purification
Core Design Contradiction:
Manufacturing precisionVSLoss of substance

Solution Approach 1:

The patent converts the presence of impurities in raw PHB-co-HV from a harmful factor into a manageable condition by using purification methods that selectively remove contaminants while preserving the desired polymer. This approach minimizes material loss by avoiding overly aggressive purification steps that would otherwise be necessary to achieve high product purity.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

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 process simplifies the PHB extraction and purification, results in a final product with better purity, and provides a mixture capable of meeting both energy and anaplerotic demands, effectively treating metabolic disorders related to brain energy deficits and glucose metabolism issues.

Implementation Method 1

A low-cost enzymatic process for purifying PHB-co-HV prior to esterification

Methodology Applied
Scientific EffectEnzyme catalysis: Enzyme

Data Source

PatentUS20240368644A1Methods to produce therapeutic formulations comprising hydroxybutirate and hydroxyvalerate, therapeutic formulations and uses thereof
Publication Date: 2024.11.07 PHB IND
  • US20240368644A1 patent drawing
  • US20240368644A1 patent drawing
  • US20240368644A1 patent drawing

AI summary

A process for producing optically active (R)-3-hydroxybutyrate and (R)-3-hydroxyvalerate mixtures, where the ratio between them is defined by the composition of PHB-co-HV, used as raw material for the production process, formulations containing the mixtures, and uses of the formulations. A use or method of treating a subject having a metabolic disorder, comprising administering optically active mixtures of (R)-3-hydroxybutyrate and (R)-3-hydroxyvalerate, their respective salts or esters derived therefrom, obtained according to the process of the present disclosure at a therapeutically effective amount to treat at least one symptom of the metabolic disorder.