Dried Microorganism Stability Using Phosphate Salt Excipients

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Solution Overview

Problem

Dried microorganisms, particularly probiotics, are not stable during storage, especially in high-humidity environments, leading to a decrease in live cell count and reduced effectiveness when blended with excipients having high humidity content or stored in permeable containers.

Innovation Solution

A composition comprising a blend of dried microorganisms and a phosphate salt in powder form, specifically dipotassium phosphate (K2HPO4), which improves the survival rate of microorganisms by more than 60% over 3 months compared to conventional excipients like microcrystalline cellulose (MCC), especially in high water activity environments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If dried microorganisms are blended with conventional excipients like microcrystalline cellulose (MCC), then the microorganisms can be packaged and administered, but the live cell count decreases significantly during storage especially in high-humidity environments

Engineering Contradiction:

Improvestability of dried microorganisms during storageVSAvoidlive cell count

Core Design Contradiction:

ReliabilityVSQuantity of substance

Solution Approach 1:

The patent changes the chemical parameters of the excipient by using phosphate salts (such as dipotassium phosphate, disodium phosphate) instead of conventional excipients like microcrystalline cellulose. This parameter change in excipient composition creates a chemical environment that maintains lower water activity and stabilizes the dried microorganisms, preventing degradation and maintaining live cell count during storage in high-humidity conditions

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent creates a composite material system by blending dried microorganisms with phosphate salt excipients. This composite formulation, where the phosphate salt serves as both excipient and stabilizing agent, provides synergistic effects that protect the microorganisms from humidity-induced degradation while maintaining administerability

Inventive Principle:

Principle #40Composite materials

2Ease of operation

If dried probiotics are stored in high relative humidity environments or with excipients having high humidity content, then packaging and administration is feasible, but the treatment effectiveness is reduced due to decreased live cell counts

Engineering Contradiction:

Improvepackaging and administration of probioticsVSAvoideffectiveness of probiotic treatment

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent modifies the water activity parameters of the probiotic formulation by incorporating phosphate salt excipients that maintain low water activity even in high-humidity environments. This parameter control allows the probiotics to be packaged and administered conveniently while simultaneously preserving their viability and effectiveness throughout storage

Inventive Principle:

Principle #35Parameter changes

3Device complexity

If container walls are permeable to external atmospheric moisture, then packaging is simpler and more cost-effective, but moisture ingress causes degradation of dried microorganisms and reduces live cell count

Engineering Contradiction:

Improvepackaging structureVSAvoidstability of dried microorganisms

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The patent applies beforehand cushioning by formulating the dried microorganisms with phosphate salt excipients that pre-establish a protective chemical environment. This formulation acts as a buffer against moisture ingress, cushioning the microorganisms from the harmful effects of atmospheric moisture even when packaging is permeable, thereby maintaining stability without requiring complex impermeable packaging structures

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

Data Source

PatentUS20250011710A1Dried microorganism with excipient

Publication Date: 2025.01.09 INT N&H DENMARK APS

AI summary

The invention provides dried microorganisms with increased shelf-life.