Lactic Acid Dosage for Vaginal Atrophy Treatment

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Solution Overview

Problem

Current treatments for vaginal atrophy and related symptoms in postmenopausal women often rely on hormone therapy, which has side effects, and non-hormonal options are insufficient in effectively addressing cellular differentiation and quality of life improvements.

Innovation Solution

The use of higher doses of lactic acid and/or lactic acid salts, specifically in the range of 120 to 5000 mg per dosage, applied topically or intravaginally in semi-solid formulations or suppositories, to adjust vaginal pH and promote cellular differentiation in the vaginal epithelial tissue.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If hormone therapy is used to treat vaginal atrophy, then symptoms are effectively treated, but side effects increase

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidside effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts and eliminates the harmful hormonal component from the treatment while retaining the beneficial effects on vaginal tissue. By using only lactic acid and lactic acid salts without hormones, the invention removes the side effects associated with hormone therapy while maintaining treatment effectiveness for vaginal atrophy symptoms.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the chemical composition parameters of the treatment formulation by using higher concentrations of lactic acid (at least 120 mg per dosage, preferably at least 200 mg) and lactic acid salts, which fundamentally alters the mechanism of action from hormonal to pH-based and direct cellular differentiation promotion, thereby achieving hormone-free treatment of vaginal atrophy.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If non-hormonal treatments are used to avoid side effects, then side effects are reduced, but cellular differentiation improvement is insufficient

Engineering Contradiction:
Improveside effectsVSAvoidcellular differentiation improvement
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent changes the dosage parameters of lactic acid to at least 120 mg per application (preferably at least 200 mg), which is significantly higher than conventional non-hormonal treatments. This parameter change enables the lactic acid to directly promote cellular differentiation in the vaginal epithelium, achieving hormone-like effects without hormonal side effects.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses a composite formulation containing both lactic acid and lactic acid salts (such as sodium lactate, potassium lactate, calcium lactate, or magnesium lactate) in specific combinations. This composite approach enhances the stability, pH-adjusting capacity, and cellular differentiation-promoting effects while maintaining a non-hormonal profile.

Inventive Principle:
Principle #40Composite materials

3Stability of the object's composition

If conventional lactic acid dosages are used to adjust vaginal pH, then pH balance is improved, but cellular differentiation is not significantly enhanced

Engineering Contradiction:
Improvevaginal pH balanceVSAvoidcellular differentiation
Core Design Contradiction:
Stability of the object's compositionVSReliability

Solution Approach 1:

The patent fundamentally changes the dosage parameter of lactic acid from conventional low doses (typically less than 100 mg) to high doses (at least 120 mg per application, preferably at least 200 mg). This parameter change transforms lactic acid's role from merely a pH-adjusting agent to a direct promoter of cellular differentiation in the vaginal epithelium, achieving both pH balance and improved cellular maturation.

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

This approach significantly improves cellular differentiation and quality of life for postmenopausal women, as measured by the vaginal maturation index and DIVA questionnaire, with minimal adverse events, providing a hormone-free and effective treatment for vaginal atrophy and related symptoms.

Implementation Method 1

The physiological pH of a healthy vagina is approximately 4. It is adjusted by the presence of lactic acid, which is produced in the vagina from glycogen by lactobacilli.

Methodology Applied
Scientific EffectpH adjustment:

Implementation Method 2

there was a significant improvement in cellular differentiation (related to parabasal cells, intermediate cells and superficial cells of the vaginal tissue), expressed by the VMI as described below

Methodology Applied
Scientific EffectCellular differentiation:

Data Source

PatentUS20250009690A1Use of lactic acid in postmenopausal women
Publication Date: 2025.01.09 DR AUGUST WOLFF GMBH & CO KG ARZNEIMITTEL
  • US20250009690A1 patent drawing
  • US20250009690A1 patent drawing

AI summary

The present invention relates to the use of lactic acid and/or lactic acid salts for the treatment and/or prevention of estrogen deficiency-related vaginal symptoms, urogenital menopausal syndrome, postmenopausal atrophic vaginitis, senile vaginitis, vulvovaginal atrophy and/or vaginal dryness in postmenopausal women.