Intravaginal Gel for Bacterial Vaginosis Recurrence

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Solution Overview

Problem

Current treatments for bacterial vaginosis (BV) often fail to effectively address the condition and its recurrence, as they do not adequately restore the vaginal microbiome balance, leading to persistent symptoms and high recurrence rates.

Innovation Solution

A composition comprising a polymer thickener, L-lactic acid, and a preservative, administered intravaginally, which helps lower vaginal pH and restore a healthy vaginal microbiome, thereby treating and preventing BV.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional treatments are used for bacterial vaginosis, then the treatment process is simple, but the recurrence rate is high and the microbiome balance is not restored

Engineering Contradiction:
Improverecurrence rateVSAvoidtreatment composition complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent uses a composite treatment composition containing multiple active ingredients (lactic acid, hydrogen peroxide, and probiotics) working together to treat BV. This multi-component formulation addresses the high recurrence rate by simultaneously lowering pH, producing antimicrobial effects, and restoring microbiome balance, while the ingredients are combined in a single intravaginal gel or suppository that maintains practical ease of use.

Inventive Principle:
Principle #40Composite materials

2Ease of operation

If antibiotics are used to treat BV, then the immediate symptoms are reduced, but the vaginal microbiome balance deteriorates further

Engineering Contradiction:
Improvesymptom relief effectivenessVSAvoidmicrobiome balance
Core Design Contradiction:
Ease of operationVSStability of the object's composition

Solution Approach 1:

The patent converts the harmful effect of disrupted microbiome into a benefit by actively restoring it through probiotic incorporation. The treatment not only addresses symptoms through lactic acid-induced pH lowering and hydrogen peroxide antimicrobial action, but also simultaneously rebuilds healthy vaginal flora with Lactobacillus probiotics, turning the potential harm of microbiome disruption into an opportunity for restoration.

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

Solution Approach 2:

The patent fundamentally changes the treatment parameter from antibacterial killing to pH-mediated bacterial selection. By lowering vaginal pH to 3.5-4.5 through lactic acid, the treatment creates an environment that naturally suppresses pathogenic bacteria while favoring Lactobacillus growth, thereby resolving symptoms while restoring microbiome balance without using broad-spectrum antibiotics.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If the vaginal pH is not maintained at acidic levels, then the treatment is simple, but BV symptoms persist and recur

Engineering Contradiction:
Improvesymptom ameliorationVSAvoidpH maintenance mechanism
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent employs self-service pH maintenance through the incorporation of lactic acid and probiotics that actively produce additional lactic acid. The lactic acid in the formulation immediately lowers pH upon application, while the probiotic Lactobacillus bacteria continuously produce lactic acid through fermentation of glycogen, thereby self-maintaining the acidic pH environment (3.5-4.5) needed to prevent BV recurrence without requiring external intervention.

Inventive Principle:
Principle #25Self-service

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 composition effectively ameliorates BV symptoms, reduces recurrence rates, and maintains a healthy vaginal microbiome, providing a more sustainable treatment solution compared to traditional methods.

Implementation Method 1

administration of the composition lowers vaginal pH of the subject, thereby treating the BV

Methodology Applied
Scientific EffectpH adjustment through L-lactic acid:

Data Source

PatentUS11419835B2Method of treatment and prevention of bacterial vaginosis
Publication Date: 2022.08.23 EVOFEM
  • US11419835B2 patent drawing
  • US11419835B2 patent drawing
  • US11419835B2 patent drawing

AI summary

Described herein are methods of reducing the risk of recurrence of bacterial vaginosis by intravaginal administration of compositions comprising L-lactic acid, polymer thickener, and preservative.