Mesh Placement to Prevent Coning in Dissolution Tests

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Solution Overview

Problem

The dissolution ratio of poorly soluble drugs from tablets and capsules is lowered and variation in dissolution ratios is enlarged when using the paddle apparatus at low rotation speeds due to coning phenomena in the dissolution test assembly, which is not addressed by existing technologies.

Innovation Solution

A mesh is placed under the blade and over the bottom of the vessel in the dissolution test assembly, with specific dimensions and sieve openings, to prevent coning and stabilize the dosage forms, allowing for consistent dissolution testing at low paddle speeds.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the paddle rotation speed is reduced to 10-30 rpm to reproduce gastrointestinal tract dissolution conditions, then the dissolution test becomes more physiologically relevant, but the dissolution ratio of poorly soluble drugs decreases and dissolution ratio variation increases due to coning

Engineering Contradiction:

Improvephysiological relevance of dissolution testVSAvoiddissolution ratio consistency

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

A mesh is introduced as an intermediary component between the paddle blade and the vessel bottom. The mesh prevents direct contact between poorly soluble drugs/insoluble ingredients and the vessel bottom, thereby preventing coning while maintaining low rotation speeds for physiological relevance.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The harmful function of the vessel bottom (causing coning) is separated from the system by introducing a mesh. The mesh extracts the negative effect of direct contact between dosage forms and vessel bottom, allowing low-speed rotation without coning.

Inventive Principle:

Principle #2Taking out (Extraction)

2Reliability

If high rotation speed (50-75 rpm) is used in the dissolution test assembly, then the dissolution ratio of drugs is maintained, but the test no longer accurately reproduces gastrointestinal tract dissolution conditions

Engineering Contradiction:

Improvedissolution ratioVSAvoidphysiological relevance

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The mesh serves as a mediator that enables low rotation speeds to achieve both physiological relevance and adequate dissolution ratios by preventing drug accumulation on the vessel bottom.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Measurement precision

If multiple identical dosage forms are measured without a mesh, then the dissolution ratio variation is enlarged due to coning, but adding a mesh prevents this variation

Engineering Contradiction:

Improvedissolution ratio variationVSAvoidassembly structure

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The mesh is a simple intermediary component that effectively prevents coning and reduces dissolution ratio variation without significantly increasing device complexity.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The mesh changes the physical parameters of the system by introducing a permeable barrier that allows fluid flow while preventing solid particle accumulation, thereby improving measurement precision.

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentUS12455270B2Mesh for dissolution test

Publication Date: 2025.10.28 SHIONOGI & CO LTD

AI summary

When the mesh is placed under the bottom of a blade and over the bottom of a vessel in the dissolution test assembly equipped with either a vessel specified in the dissolution test method of the Japanese Pharmacopoeia, the United States Pharmacopoeia or the European Pharmacopoeia or a vessel used for the dissolution test, and a paddle formed from a blade and a shaft, and the suspensions and the solid dosage forms are added to or placed at the said mesh, a drug dissolves from the said dosage forms and the dissolution ratio variation between the said multiple same dosage forms can be small.