Probiotic Bacterial Composition Stability via Low Water Activity

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Solution Overview

Problem

Probiotic strains are highly sensitive and often fail to survive commercial production, storage, or gastrointestinal transit due to exposure to heat, moisture, bile, low pH, and digestive enzymes, leading to a significant reduction in viable counts before reaching the intestine.

Innovation Solution

Formulating bacterial compositions with a combination of at least seven different bacterial strains, silica, fructooligosaccharides, magnesium stearate, and a low moisture filler like microcrystalline cellulose, which maintains a water activity less than 0.3, ensuring the stability and viability of at least 80% of the bacteria for up to 24 months, and using coatings or encapsulation to prevent moisture adsorption and ensure delivery to the intestines.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If probiotic strains are formulated in conventional formulations, then they can be produced and stored, but they fail to survive commercial production, storage, or gastrointestinal transit due to exposure to heat, moisture, bile, low pH, and digestive enzymes

Engineering Contradiction:
Improvesurvival rate of probiotic strainsVSAvoidexposure to heat, moisture, bile, low pH, and digestive enzymes
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies beforehand cushioning by incorporating multiple protective mechanisms into the formulation before the probiotics encounter harsh conditions. This includes using protective carriers, optimizing formulation composition, and creating a protective matrix that cushions the probiotics against heat, moisture, bile, low pH, and digestive enzymes during commercial production, storage, and gastrointestinal transit.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

Solution Approach 2:

The patent employs composite materials by formulating probiotics with a combination of protective carriers, excipients, and formulation components that work synergistically. This composite formulation approach creates a multi-layered protection system that addresses multiple harmful factors simultaneously, enhancing the survival rate of probiotic strains through commercial production, storage, and gastrointestinal transit.

Inventive Principle:
Principle #40Composite materials

2Duration of action of stationary object

If probiotic formulations are stored for extended periods, then shelf life is extended, but viability of bacteria decreases due to degradation over time

Engineering Contradiction:
Improveshelf life of probiotic formulationVSAvoidviability of probiotic bacteria
Core Design Contradiction:
Duration of action of stationary objectVSReliability

Solution Approach 1:

The patent applies preliminary action by optimizing the formulation composition and protective mechanisms before storage begins. This includes pre-establishing protective carriers, adjusting formulation pH, and incorporating stabilizing agents that proactively prevent degradation during extended storage, thereby maintaining bacterial viability throughout the shelf life period.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent employs parameter changes by modifying formulation parameters such as water activity, pH, and oxygen content to create an environment that preserves probiotic viability during extended storage. By controlling these physical and chemical parameters, the formulation maintains bacterial stability and prevents degradation over the intended shelf life.

Inventive Principle:
Principle #35Parameter changes

3Adaptability or versatility

If multiple bacterial strains are combined in a single formulation, then diversity and effectiveness are improved, but stability and uniformity of the composition become more difficult to maintain

Engineering Contradiction:
Improvediversity of bacterial strainsVSAvoidstability of multi-strain formulation
Core Design Contradiction:
Adaptability or versatilityVSStability of the object's composition

Solution Approach 1:

The patent applies segmentation by dividing the multi-strain formulation into distinct protective compartments or using separate protective mechanisms for different strain types. This segmentation approach allows each bacterial strain to be optimized and protected individually while maintaining overall formulation stability and uniformity throughout storage and transit.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs homogeneity by using a unified protective carrier system and standardized formulation approach that treats all bacterial strains consistently. This homogeneous formulation strategy ensures uniform distribution, stability, and protection across all multiple bacterial strains, maintaining composition integrity while preserving strain diversity.

Inventive Principle:
Principle #33Homogeneity

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 described formulation maintains the viability of probiotic bacteria during storage and ensures their effective delivery to the intestines, providing a stable and effective probiotic dose for extended periods, enhancing gastrointestinal bioavailability and health benefits.

Implementation Method 1

a single bacterial composition (e.g., a capsule or tablet or sachet) can be formulated to include at least seven different bacterial strains, a form of silica (e.g., silica powder), fructooligosacchride, magnesium stearate, and a low moisture filler (e.g., a microcrystalline cellulose such as MCC 112) to provide a final composition with a water activity (Aw) less than 0.3

Methodology Applied
Scientific EffectWater activity reduction: Absorption (physical)

Implementation Method 2

The bacterial compositions provided herein can be coated with a coating agent and/or encapsulated to minimize or prevent moisture adsorption and to minimize water activity of the final blend

Methodology Applied
Scientific EffectAdsorption prevention: Adsorption

Data Source

PatentUS11433107B2Bacterial compositions
Publication Date: 2022.09.06 MELALEUCA INC

AI summary

This document provides bacterial compositions. For example, bacterial compositions having a combination of different bacterial strains formulated in a manner to maintain the stability of the bacteria are provided.