Closed Vial for Lyophilized Probiotic Suspension
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Solution Overview
Problem
The volatility of lyophilized Saccharomyces boulardii powder leads to undesirable effects such as fungemia, particularly in immunocompromised patients and those with central venous catheters, necessitating a safer administration method.
Innovation Solution
A closed vial design with airtight compartments containing lyophilized S. boulardii powder and a solution, allowing for airtight communication upon opening to create a suspension, minimizing yeast dissemination and opportunistic infections.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If lyophilized S. boulardii powder is administered directly, then the probiotic can be delivered effectively, but volatile dissemination occurs leading to fungemia and opportunistic infections
Solution Approach 1:
The vial is divided into two separate compartments: a first compartment containing the lyophilized S. boulardii powder and a second compartment containing the reconstitution solution. This segmentation prevents contact between the yeast powder and moisture until the moment of administration, eliminating volatile dissemination and fungemia risk while preserving the probiotic's effectiveness.
2Reliability
If S. boulardii is avoided in immunocompromised patients to prevent fungemia, then safety is improved, but these patients lose access to beneficial treatment for diarrhea management
Solution Approach 1:
By segmenting the product into separate dry powder and liquid compartments, the invention enables safe administration to immunocompromised patients. The yeast remains dormant and non-volatile until reconstitution at the moment of use, eliminating the fungemia risk that previously contraindicated treatment in this vulnerable population.
Solution Approach 2:
The yeast is prepared in a dormant lyophilized state in the first compartment, preventing any risk of dissemination before administration. The solution is prepared separately in the second compartment. Only at the moment of use are the two compartments combined, ensuring the yeast is activated and administered simultaneously, making the treatment safe for immunocompromised patients.
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 design enhances the safety of S. boulardii administration by preventing volatile dissemination, thereby reducing the risk of fungemia and ensuring effective delivery of the probiotic while maintaining its viability and health benefits.
Implementation Method 1
the composition comprises lyophylized Saccharomyces boulardii as an active ingredient
Data Source
Figure 1
AI summary
The present invention relates to a dietary supplement or pharmaceutical composition, comprising lyophylized Saccharomyces boulardii as an active ingredient and as sole probiotic, optionally in association with a pharmaceutically acceptable vehicle, wherein the composition is in a closed vial a having a first airtight compartment comprising lyophilized S. boulardii powder, and a second compartment comprising a solution, wherein the first and second compartment can be brought in airtight communication with one another to yield a suspension of S. boulardii to be administered to an individual upon opening of the vial.