3SL Sodium Salt Hydrate Crystallization for Storage Stability

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Solution Overview

Problem

Current methods for producing 3′-sialyllactose sodium salt crystals are ineffective, failing to achieve stable crystal formation with high storage and handling properties.

Innovation Solution

A process involving the precipitation of 3′-sialyllactose sodium salt hydrate crystals by allowing a 3′-sialyllactose aqueous solution containing a sodium-containing compound to stand or be stirred, with optional seed crystal addition and alcohol solution treatment, followed by controlled drying to achieve stable crystal forms with specific X-ray diffraction patterns and hydration levels.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If conventional purification methods (gel filtration, simulated moving-bed chromatography) are used to produce 3SL, then purification is achieved, but crystal formation is not obtained

Engineering Contradiction:
Improvecrystal formationVSAvoidproduction method complexity
Core Design Contradiction:
Manufacturing precisionVSEase of manufacture

Solution Approach 1:

The invention changes the chemical parameters by converting 3SL to its sodium salt form through reaction with sodium hydroxide or sodium carbonate. This parameter change enables crystal formation, as the sodium salt exhibits different solubility and crystallization properties compared to the free acid form, allowing crystals to be obtained from aqueous solutions without complex chromatographic methods

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention utilizes phase transition by controlling the crystallization process from aqueous solution. By adjusting concentration, temperature, and pH to precipitate the sodium salt as crystals, the method transforms the 3SL from a state where crystals cannot form (in conventional purification) to a state where stable crystals precipitate, achieving both purification and crystal formation

Inventive Principle:
Principle #36Phase transitions

2Reliability

If 3SL is produced without crystallization, then production is simpler, but storage stability and handling properties deteriorate

Engineering Contradiction:
Improvestorage stabilityVSAvoidcrystal production process
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

By changing the chemical form to sodium salt through controlled reaction with sodium hydroxide or sodium carbonate, the invention achieves a crystalline state that provides superior storage stability and handling properties compared to amorphous or non-crystalline forms, while maintaining a relatively simple production process

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention allows the 3SL sodium salt to self-organize into crystals through controlled precipitation from aqueous solution. By simply concentrating the solution and adjusting pH, the crystals form automatically without requiring complex equipment or multi-step purification processes, achieving both simplicity and stability

Inventive Principle:
Principle #25Self-service

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 process yields crystals with high purity and stability, exhibiting improved storage and handling characteristics, including reduced hygroscopicity and increased storage stability, and maintains structural integrity under varying conditions.

Implementation Method 1

A process involving the precipitation of 3′-sialyllactose sodium salt hydrate crystals by allowing a 3′-sialyllactose aqueous solution containing a sodium-containing compound to stand or be stirred

Methodology Applied
Scientific EffectCrystallisation: Crystallisation

Implementation Method 2

A process involving the precipitation of 3′-sialyllactose sodium salt hydrate crystals by allowing a 3′-sialyllactose aqueous solution containing a sodium-containing compound to stand or be stirred

Methodology Applied
Scientific EffectPrecipitation: Precipitation

Implementation Method 3

with optional seed crystal addition and alcohol solution treatment, followed by controlled drying to achieve stable crystal forms with specific X-ray diffraction patterns and hydration levels

Methodology Applied
Scientific EffectPhase Change: Phase Change

Implementation Method 4

followed by controlled drying to achieve stable crystal forms with specific X-ray diffraction patterns and hydration levels

Methodology Applied
Scientific EffectEvaporation: Evaporation

Data Source

PatentUS11008355B2Crystal of 3'-sialyllactose sodium salt n-hydrate, and process for producing same
Publication Date: 2021.05.18 PLUMINO PRECISION FERMENTATION JAPAN CO LTD
  • US11008355B2 patent drawing
  • US11008355B2 patent drawing
  • US11008355B2 patent drawing

AI summary

An object of the present invention is to provide a crystal of 3′-sialyllactose (hereinafter, referred to as 3SL), which is easily handled, and has high storage stability at normal temperature as well as under high temperature conditions, and provide a process for producing the same. The present invention relates to a 3SL sodium salt n-hydrate (wherein n represents any number of 0 to 9, and when n is 0, it is referred to as 3SL sodium salt anhydrate) and a process for producing the same.