Orally-Disintegrating Tablet Hardness and Disintegration Trade-off

Solution Overview

Problem

Orally-disintegrating tablets face challenges with poor mechanical strength, making them difficult to handle with automatic packaging machines and resulting in reduced disintegration times in the buccal cavity when attempting to increase hardness for better handling properties.

Innovation Solution

A combination of D-mannitol powder and sugar alcohol granules is used, with the mixture compressed to achieve a hardness of 30 N or greater, allowing for effective disintegration in the buccal cavity while maintaining mechanical strength, using a normal tableting machine without special devices.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If the mechanical strength of orally-disintegrating tablets is increased to improve handling properties, then the tablets become easier to handle with automatic packaging machines, but the disintegration time in the buccal cavity increases

Engineering Contradiction:

Improvemechanical strengthVSAvoiddisintegration time

Core Design Contradiction:

StrengthVSLoss of time

Solution Approach 1:

The sugar alcohol is segmented into two distinct forms: powder (providing disintegration properties) and granules (providing molding properties). This segmentation allows each form to contribute its specific advantage without the drawbacks of the other, resolving the contradiction between mechanical strength and disintegration time.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The invention uses a composite formulation combining sugar alcohol powder and sugar alcohol granules in specific proportions (3:7 to 7:3 by weight). This composite approach integrates the beneficial properties of both forms - the powder provides rapid disintegration while the granules provide adequate mechanical strength for handling.

Inventive Principle:

Principle #40Composite materials

2Loss of time

If sugar alcohol is used in fine powder form to achieve good disintegration properties, then the tablets disintegrate rapidly in the buccal cavity, but the molding properties deteriorate and tableting becomes difficult

Engineering Contradiction:

Improvedisintegration timeVSAvoidmolding properties

Core Design Contradiction:

Loss of timeVSEase of manufacture

Solution Approach 1:

The sugar alcohol is segmented into two distinct forms: powder (providing disintegration properties) and granules (providing molding properties). This segmentation allows each form to contribute its specific advantage without the drawbacks of the other, resolving the contradiction between mechanical strength and disintegration time.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The invention uses a composite formulation combining sugar alcohol powder and sugar alcohol granules in specific proportions (3:7 to 7:3 by weight). This composite approach integrates the beneficial properties of both forms - the powder provides rapid disintegration while the granules provide adequate mechanical strength for handling.

Inventive Principle:

Principle #40Composite materials

3Ease of manufacture

If granulated sugar alcohol is used to improve molding properties, then the tablets can be formed more easily, but the disintegration properties in the buccal cavity deteriorate

Engineering Contradiction:

Improvemolding propertiesVSAvoiddisintegration time

Core Design Contradiction:

Ease of manufactureVSLoss of time

Solution Approach 1:

The sugar alcohol is segmented into two distinct forms: powder (providing disintegration properties) and granules (providing molding properties). This segmentation allows each form to contribute its specific advantage without the drawbacks of the other, resolving the contradiction between mechanical strength and disintegration time.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The invention uses a composite formulation combining sugar alcohol powder and sugar alcohol granules in specific proportions (3:7 to 7:3 by weight). This composite approach integrates the beneficial properties of both forms - the powder provides rapid disintegration while the granules provide adequate mechanical strength for handling.

Inventive Principle:

Principle #40Composite materials

Data Source

PatentEP1980272B1Orally-disintegrating tablet and manufacturing method thereof

Publication Date: 2015.07.08 NIPRO CORP

AI summary

An orally-disintegrating tablet comprises a principal agent, a sugar alcohol powder and a sugar alcohol granule, wherein the orally-disintegrating tablet has a hardness of 30 N or greater. According to the present invention, a smooth swallowing orally-disintegrating tablet, for which both the mechanical strength and the disintegration properties in the buccal cavity are favorable with using a normal tableting machine and without using special devices and the feeling on the tongue and taste are favorable, is provided.