Alcohol-Based Microemulsion for Oral DHEA Hormone Delivery

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Solution Overview

Problem

Conventional delivery systems for nonderivatized hormones face challenges in achieving therapeutically effective bloodstream concentrations due to poor solubility in oil and water, unstable emulsion droplet sizes, and variable hormone release profiles, leading to liver stress and undesirable side effects.

Innovation Solution

A modified oil-in-water microemulsion (MOIW) system is developed, using a phospholipid, polyethylene glycol derivative, alcohol, and sugar or sugar alcohol to solubilize alcohol-soluble species like DHEA and pregnenolone, allowing for stable, oral delivery without significant liver stress and achieving desired hormone concentrations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If nonderivatized hormones are delivered orally in solid or suspended form, then bloodstream concentrations can be achieved, but greater than medically necessary dosages are needed and liver stress increases

Engineering Contradiction:

Improvehormone dosageVSAvoidliver stress

Core Design Contradiction:

Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The patent changes the physical state parameter of the hormone from solid/suspended form to dissolved form in an alcohol-based microemulsion delivery system. This parameter change allows the hormone to be delivered in lower quantities while achieving the same bloodstream concentration, thereby reducing liver stress from excessive dosing.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent introduces an alcohol-based microemulsion delivery system as an intermediary between the hormone and the body's absorption systems. This intermediary enhances the solubility and bioavailability of nonderivatized hormones, allowing for more efficient delivery at lower dosages and reducing the metabolic burden on the liver.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If transdermal creams and gels are used to bypass liver metabolism, then hormone delivery is improved, but absorption rates are poor and variable

Engineering Contradiction:

Improvehormone delivery efficiencyVSAvoidabsorption rate consistency

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent changes the delivery route parameter from transdermal to oral, and simultaneously changes the formulation parameter to an alcohol-based microemulsion. This combination provides more consistent and predictable absorption rates compared to transdermal delivery, while maintaining reliable hormone delivery to the bloodstream.

Inventive Principle:

Principle #35Parameter changes

3Ease of operation

If conventional oral delivery systems are used, then hormone delivery is simple, but extensive metabolism occurs in the liver and hormone effectiveness is reduced

Engineering Contradiction:

Improvedelivery simplicityVSAvoidhormone effectiveness

Core Design Contradiction:

Ease of operationVSQuantity of substance

Solution Approach 1:

The patent introduces an alcohol-based microemulsion delivery system as an intermediary that protects the hormone from extensive first-pass metabolism in the liver. This intermediary enhances bioavailability and hormone effectiveness while maintaining the simplicity of oral administration.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the formulation parameter from conventional solid/suspended oral delivery to an alcohol-based microemulsion. This parameter change significantly improves hormone bioavailability and effectiveness while maintaining oral simplicity, as the hormone is already in a dissolved, bioavailable state.

Inventive Principle:

Principle #35Parameter changes

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 MOIW microemulsion provides rapid, efficient, and reproducible oral delivery of nonderivatized hormones, increasing bloodstream concentrations of DHEA and testosterone while reducing estradiol levels, effectively alleviating menopausal symptoms such as hot flashes, mood swings, and weight gain.

Implementation Method 1

Methodology Applied

Scientific EffectMicroemulsion: Microemulsion

Implementation Method 2

the alcohol-soluble species is solubilized in the modified oil phase

Methodology Applied

Scientific EffectSolvation: Solvation

Data Source

PatentUS12527804B2Microemulsion delivery systems for alcohol-soluble species including DHEA, pregnenolone, and chrysin for reducing menopausal symptoms

Publication Date: 2026.01.20 QUICKSILVER SCIENTIFIC INC

AI summary

Microemulsions are described where hydrophobic liquid droplets are distributed in a continuous hydrophilic liquid phase. In relation to conventional oil-in-water (OIW) microemulsions, the described microemulsions may be thought of as modified oil-in-water (MOIW) microemulsions, where both the “oil” and “water” phases of the microemulsion are modified. The oil phase droplets of the MOIW microemulsion are modified with alcohol and can solubilize alcohol-soluble species, including nonderivatized hormones. More preferably, the modified oil phase droplets of the MOIW microemulsion directly solubilize nonderivatized hormones. The oil phase droplets of the MOIW microemulsion include DHEA, pregnenolone, and a polyphenol, where a ratio of DHEA to polyphenol is from 1:1 to 12:1 by weight. Methods of supporting and/or increasing bloodstream hormone levels in perimenopausal and postmenopausal females and improving menopausal symptoms also are disclosed.