Postbiotic Vaginal Composition Using Inactivated L. crispatus and D-Lactate
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Solution Overview
Problem
There is a need for paraprobiotics and other postbiotics that maintain and/or restore homeostasis in the vaginal environment, as existing probiotic solutions may not be suitable for all populations, particularly pediatric and immunocompromised individuals, and the vaginal microbiome differs significantly from the gut microbiome, posing risks for adverse gynecologic and obstetric outcomes.
Innovation Solution
A postbiotic composition comprising inactivated Lactobacillus crispatus cells and D-lactate, optionally with a probiotic component, formulated for intravaginal or topical administration, to enhance epithelial barrier integrity and induce immunological shifts, modulate the vaginal microbiome, and reduce pH.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If live probiotic bacteria are administered to maintain vaginal microbiome homeostasis, then the microbiome modulation effect is improved, but safety concerns arise for pediatric and immunocompromised populations
Solution Approach 1:
The patent extracts the beneficial functional components from live bacteria, specifically using bacterial metabolites (lactate, hydrogen peroxide) and cell wall components (peptidoglycans, lipoteichoic acids) that can modulate the vaginal microbiome and provide protective effects without requiring live bacterial cells, thereby eliminating safety concerns for immunocompromised populations while maintaining therapeutic effectiveness
Solution Approach 2:
The patent creates a postbiotic composition that copies the beneficial effects of live probiotics by incorporating metabolites and structural components that mimic the protective mechanisms of live Lactobacillus species, providing similar microbiome modulation and protective functions without the risks associated with live bacteria in vulnerable populations
2Reliability
If live probiotic bacteria are used for vaginal microbiome restoration, then therapeutic benefits are achieved, but shelf stability and manufacturing complexity increase
Solution Approach 1:
The patent extracts the essential therapeutic components (metabolites and cell wall elements) from live bacteria, creating a stable postbiotic formulation that maintains therapeutic benefits while eliminating the shelf stability issues associated with maintaining live bacterial cultures
Solution Approach 2:
The patent changes the physical and biological state of the bacterial components from live cells to inactivated forms with preserved metabolites and structural elements, transforming the product into a stable formulation that maintains therapeutic efficacy without the complexity of live culture maintenance
3Reliability
If live probiotic bacteria are administered, then microbiome modulation is achieved, but production cost and manufacturing difficulty increase
Solution Approach 1:
The patent extracts the active therapeutic components from bacteria and formulates them as stable postbiotics, simplifying manufacturing by eliminating the need for complex live culture maintenance, quality control of viability, and cold chain storage requirements associated with probiotic production
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 improves vaginal health by enhancing barrier function, inducing anti-inflammatory states, and modulating the microbiome, providing therapeutic benefits for conditions such as bacterial vaginosis, pelvic inflammatory disease, and obstetric complications.
Implementation Method 1
Lactobacillus crispatus cells and D-lactate, wherein the D-lactate is produced as a product or byproduct of a metabolic process of the Lactobacillus crispatus cells
Data Source
AI summary
Postbiotic compositions for maintenance and/or restoration of a healthy vaginal environment and/or microbiome are disclosed. The postbiotic compositions include a paraprobiotic component, comprising inactivated cells of Lactobacillus crispatus, and a metabolite component, comprising D-lactate.