Dry Vaginal Lactobacillus Formulation for Stable Colonization
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Solution Overview
Problem
Existing Lactobacillus products fail to effectively colonize the vagina due to poor quality, contamination with pathogens, and low viability, leading to ineffective treatment of vaginal infections.
Innovation Solution
Aqueous bacterial suspension of vaginal Lactobacillus species with trehalose, xylitol, sodium ascorbate, and sodium phosphate, lyophilized into a dry powder, ensuring high viability and adherence to vaginal epithelial cells without animal-derived excipients.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If vaginal lactobacillus is administered to treat bacterial vaginosis, then therapeutic benefit is achieved, but the bacteria fail to persist long-term in the vaginal environment
Solution Approach 1:
The patent applies preliminary action by pre-coating vaginal lactobacillus with protective materials (such as alginate, chitosan, or lipid-based materials) before administration. This pre-protection enables the bacteria to survive the harsh vaginal environment initially, allowing them to establish themselves and then provide long-term therapeutic benefit without requiring repeated dosing.
2Reliability
If vaginal lactobacillus is administered to restore healthy flora, then therapeutic benefit is achieved, but the bacteria are eliminated by vaginal pH and peroxidase within hours
Solution Approach 1:
The patent implements beforehand cushioning by enclosing vaginal lactobacillus in protective capsules or coatings made from materials like alginate, chitosan, or lipids before administration. These protective layers act as a cushion against the harsh vaginal environment (low pH and peroxidase), allowing the bacteria to survive initially and then thrive, thereby extending their survival time from hours to potentially long-term persistence.
3Reliability
If high potency formulations are used to ensure therapeutic benefit, then treatment effectiveness is improved, but stability and shelf-life of the formulation deteriorate
Solution Approach 1:
The patent applies segmentation by dividing the formulation into distinct functional components: a core containing the vaginal lactobacillus, a protective coating layer (such as alginate, chitosan, or lipid materials), and potentially additional stabilizing agents. This segmented structure allows the core to maintain high potency for treatment effectiveness while the separate protective layers provide stability and extend shelf-life by isolating the sensitive bacteria from degrading environmental factors.
Data Source
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AI summary
This invention provides for a dry preserved formulation of Lactobacillus suitable for administration to people as a pro-biotic or live biotherapeutic treatment where the formulation is stable, has high potency, and contains no animal-derived excipients.