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

VSEngineering 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

Engineering Contradiction:
Improvesafety of administrationVSAvoidvolatile dissemination of yeast
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

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.

Inventive Principle:
Principle #1Segmentation

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

Engineering Contradiction:
Improvesafety for immunocompromised patientsVSAvoidtreatment availability for immunocompromised patients
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

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.

Inventive Principle:
Principle #1Segmentation

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.

Inventive Principle:
Principle #10Preliminary action

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

Methodology Applied
Scientific EffectLyophilization: Freeze Drying

Data Source

PatentEP3160263B1Compositions for preventing infections
Publication Date: 2021.08.11 BIOCODEX INC
  • EP3160263B1 patent drawingFigure 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.