Buffered Lactobacillus Dried Formulations for Acidic Viability
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Solution Overview
Problem
Existing methods for administering Lactobacillus bacteria to the vaginal mucosa, such as dried tablets and suppositories, suffer from low viability and poor recovery in acidic environments, affecting the effectiveness of Lactobacillus Replacement Therapy (LRT) in maintaining vaginal health.
Innovation Solution
A method involving a dried formulation of live microbial cells with a buffering agent having a pKa of at least 4.3, which maintains a pH of at least 4.3 when dissolved in water with the addition of 0.1N HCl, is used to enhance stability and recovery of Lactobacillus species like L. crispatus and L. jensenii, ensuring effective vaginal colonization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If dried Lactobacillus preparations are administered as vaginal tablets, capsules, or suppositories, then the bacteria can be delivered to the vaginal mucosa, but the viability and recovery of cells are low due to poor stability in acidic environments
Solution Approach 1:
The patent introduces a buffering agent as an intermediary substance between the Lactobacillus cells and the acidic vaginal environment. This buffering agent mediates the interaction by neutralizing excess acid, thereby protecting the bacterial cells from acid-induced damage and improving their viability and recovery after administration.
Solution Approach 2:
The patent modifies the chemical environment by changing the pH parameter of the vaginal milieu through the addition of a buffering agent. By adjusting and stabilizing the pH level, the preparation creates a more favorable environment for Lactobacillus cell survival, directly addressing the stability issue in acidic conditions.
2Reliability
If conventional dried formulations are used without buffering agents, then the preparations are simple and easy to manufacture, but the therapeutic efficacy is reduced due to low cell recovery
Solution Approach 1:
The patent creates a composite formulation by combining Lactobacillus cells with a buffering agent in a single dried preparation. This composite material approach integrates multiple functional components (bacterial cells for therapy and buffering agent for pH stabilization) into one unified product, improving therapeutic efficacy while maintaining practical manufacturability.
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 buffering agent significantly improves the stability and recovery of Lactobacillus bacteria upon rehydration in acidic environments, leading to improved vaginal colonization and enhanced therapeutic efficacy in preventing urogenital infections.
Implementation Method 1
The dried formulation comprises at least one buffering agent having a pKa of at least 4.3 and wherein 140 mg of the dried microbial formulation dissolved in 3 ml of water maintains a pH of at least 4.3 with the addition of 60 μl of 0.1N HCl
Data Source
AI summary
The present invention relates to methods and compositions for Lactobacillus Replacement Therapy (LRT). Methods for improved stability and recovery of dried bacterial preparations are also provided.