Amino Acid Granule Preparation Bulk Density Optimization

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Solution Overview

Problem

Conventional amino acid-containing granule preparations are bulky and difficult to swallow due to large particle size, leading to discomfort and reduced absorbability, which affects medication compliance.

Innovation Solution

A granule preparation containing isoleucine, leucine, and valine at a specific weight ratio, with a maximum particle size of not more than 1000 µm and a bulk density of not less than 0.57 g/mL, achieved through a stirring granulation method and milling step, ensuring not more than 15% of granules are 355 microns or less, enhancing ease of ingestion and disintegration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If particle size of granules is reduced to decrease the sensation of foreign body during ingestion, then ease of ingestion is improved, but volume increases and granules become bulky in the mouth making swallowing difficult

Engineering Contradiction:
Improveease of ingestionVSAvoidvolume
Core Design Contradiction:
Ease of operationVSVolume of stationary object

Solution Approach 1:

The patent applies parameter changes by optimizing the particle size distribution parameters. Specifically, it controls the granule size to have a maximum particle size of not more than 1000 μm with a specific distribution pattern, and adjusts the bulk density to not less than 0.57 g/mL. This parameter optimization resolves the contradiction by finding the optimal balance point where granules are small enough to avoid foreign body sensation but dense enough to maintain compact volume.

Inventive Principle:
Principle #35Parameter changes

2Volume of stationary object

If consolidation during granulation is increased to decrease the volume, then volume is reduced, but granules are enlarged and the feeling on the tongue is degraded increasing foreign body sensation

Engineering Contradiction:
ImprovevolumeVSAvoidease of ingestion
Core Design Contradiction:
Volume of stationary objectVSEase of operation

Solution Approach 1:

The patent resolves this contradiction by precisely controlling the bulk density parameter within the range of not less than 0.57 g/mL and not more than 0.75 g/mL. This optimized density parameter allows the granules to achieve reduced volume while maintaining appropriate size characteristics that prevent foreign body sensation, effectively balancing both requirements through parameter optimization.

Inventive Principle:
Principle #35Parameter changes

3Volume of stationary object

If granulation is promoted to decrease volume, then volume is reduced, but disintegration of granules decreases which may lower absorbability

Engineering Contradiction:
ImprovevolumeVSAvoiddisintegration property
Core Design Contradiction:
Volume of stationary objectVSReliability

Solution Approach 1:

The patent resolves this contradiction by optimizing the bulk density parameter to not less than 0.57 g/mL. This specific density range achieves the dual benefit of volume reduction while maintaining disintegration properties. The controlled consolidation during granulation at this optimal density ensures granules remain compact yet sufficiently porous to disintegrate properly for absorbability.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP2179731B1Amino-acid-containing medicinal granular preparation highly easy to take
Publication Date: 2017.06.07 AJINOMOTO CO INC

AI summary

The present invention aims to provide an amino acid-containing granule preparation improved in the ease of taking medication than conventional products, which disintegrates rapidly. The amino acid-containing granule preparation of the present invention containing granules having a maximum particle size of substantially not more than 1000 µm and a bulk density of not less than 0.57 g/mL markedly improves ease of taking medication without impairing disintegration property, as compared to conventional amino acid-containing granule preparations.