Sodium Acetate Trihydrate Formulation Stability

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Solution Overview

Problem

Sodium acetate trihydrate (SAT) formulations in devices are prone to spontaneous crystallization due to mechanical stresses during handling and transportation, leading to unpredictable heat source activation, which is undesirable in non-regenerable devices.

Innovation Solution

Incorporating kinetic inhibitors such as sodium carboxymethyl cellulose, gelatine, and solvents like ethylene glycol into SAT formulations to enhance stability and maintain peak temperature upon crystallization, while using potassium acetate to disrupt crystal formation and increase thermal output.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If kinetic inhibitors and solvents are added to SAT formulations, then stability against spontaneous crystallization is improved, but device complexity increases

Engineering Contradiction:
Improvestability against spontaneous crystallizationVSAvoidformulation complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

Kinetic inhibitors such as sodium carboxymethyl cellulose, gelatine, and other polymers are introduced as intermediary substances that interfere with the nucleation process of SAT crystallization. These inhibitors act as mediators between the SAT molecules, preventing spontaneous crystal formation while maintaining the supercooled liquid state, thereby improving reliability without fundamentally changing the device structure

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The formulation parameters are modified by adding specific components (kinetic inhibitors and solvents) in controlled amounts. The kinetic inhibitors are included at concentrations of 0.01-1% by weight, and solvents like ethylene glycol are added at 1-5% by weight, changing the physical and chemical parameters of the SAT formulation to enhance stability while maintaining functionality

Inventive Principle:
Principle #35Parameter changes

2Reliability

If kinetic inhibitors are added to inhibit nucleation, then spontaneous crystallization is reduced, but peak temperature upon crystallization may be affected

Engineering Contradiction:
Improveresistance to spontaneous crystallizationVSAvoidpeak temperature upon crystallization
Core Design Contradiction:
ReliabilityVSTemperature

Solution Approach 1:

The formulation parameters are carefully adjusted to balance two competing requirements: adding kinetic inhibitors at optimal concentrations (0.01-1% by weight) to suppress spontaneous nucleation while maintaining the peak crystallization temperature within the desired range of 40-60°C. This involves precise control of inhibitor concentration and formulation composition

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The kinetic inhibitors are distributed uniformly throughout the SAT formulation to provide localized stabilization at multiple nucleation sites. This uniform distribution ensures that the inhibition effect is consistent across the entire formulation, preventing spontaneous crystallization while maintaining uniform thermal properties and peak temperature upon activation

Inventive Principle:
Principle #3Local quality

3Reliability

If solvents like ethylene glycol are included in the formulation, then stability is enhanced, but manufacturing precision requirements increase

Engineering Contradiction:
Improveformulation stabilityVSAvoidformulation composition control
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The formulation includes solvents such as ethylene glycol at specific concentration ranges (1-5% by weight of the formulation) to enhance stability. These parameter changes require precise manufacturing control to ensure consistent performance, but the use of commercial-grade solvents with known properties helps manage the precision requirements

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention creates a composite formulation system combining SAT, kinetic inhibitors, and solvents into a stable mixture. This composite approach allows the individual components to work synergistically, where the solvent enhances the effectiveness of the kinetic inhibitor and stabilizes the overall formulation, reducing sensitivity to minor manufacturing variations

Inventive Principle:
Principle #40Composite materials

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 formulations exhibit increased stability and thermal output, with fewer samples crystallizing under mechanical stress tests, maintaining peak temperatures between 40 to 60°C and reducing unintentional phase changes, thus addressing the issue of spontaneous activation.

Implementation Method 1

Sodium acetate trihydrate (SAT) is a phase change material which emits heat when the supercooled liquid form crystallises

Methodology Applied
Scientific EffectPhase change: Phase Change

Implementation Method 2

when the supercooled liquid form crystallises

Methodology Applied
Scientific EffectCrystallisation: Crystallisation

Implementation Method 3

emits heat when the supercooled liquid form crystallises

Methodology Applied
Scientific EffectLatent heat: Latent Heat

Implementation Method 4

The kinetic inhibitor is an additive that acts to inhibit nucleation

Methodology Applied
Scientific EffectNucleation inhibition: Nucleation

Implementation Method 5

using potassium acetate to disrupt crystal formation and increase thermal output

Methodology Applied
Scientific EffectCrystal structure disruption: Crystallisation

Data Source

PatentEP3016533B1Inhalation device comprising sodium acetate trihydrate formulations
Publication Date: 2019.10.30 BRITISH AMERICAN TOBACCO (INVESTMENTS) LTD
  • EP3016533B1 patent drawingFigure 1
  • EP3016533B1 patent drawingFigure 2
  • EP3016533B1 patent drawingFigure 3

AI summary

The present invention relates to formulations comprising sodium acetate trihydrate and other components. In addition, the invention further relates to methods of preparing such formulations. Furthermore, the invention relates to products including such formulation