Orally Disintegrating Tablet Additive Composition for Hardness and Disintegration Balance

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Solution Overview

Problem

Orally disintegrating tablets face a challenge in achieving a balance between tablet hardness and disintegration time, as higher hardness tends to lengthen disintegration time and vice versa.

Innovation Solution

The addition of a (meth)acrylic polymer and/or a cellulosic polymer to an additive composition for orally disintegrating tablets, which includes an excipient, crystalline cellulose, and a swellable water-insoluble polymer, improves moldability by enhancing tablet hardness while maintaining a short disintegration time.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If molding pressure is increased to enhance tablet hardness, then tablet hardness is improved, but disintegration time is lengthened

Engineering Contradiction:
Improvetablet hardnessVSAvoiddisintegration time
Core Design Contradiction:
StrengthVSLoss of time

Solution Approach 1:

The patent introduces a novel additive composition with specific chemical parameters (polymer type, molecular weight, composition ratios) that changes the physical-chemical properties of the tablet matrix. This allows the tablet to achieve high hardness through chemical bonding rather than mechanical compression, thereby resolving the contradiction between hardness and disintegration time

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses a composite additive system comprising multiple components: (meth)acrylic polymer, cellulosic polymer, and superdisintegrant in specific ratios. This composite material provides both binding strength for hardness and disintegration promotion, simultaneously addressing both contradictory requirements

Inventive Principle:
Principle #40Composite materials

2Loss of time

If molding pressure is decreased to shorten disintegration time, then disintegration time is shortened, but tablet hardness is reduced

Engineering Contradiction:
Improvedisintegration timeVSAvoidtablet hardness
Core Design Contradiction:
Loss of timeVSStrength

Solution Approach 1:

By changing the chemical composition parameters of the tablet matrix through the additive system, the patent enables rapid disintegration without relying on high compression pressure. The superdisintegrant and polymer network structure facilitate quick water penetration and matrix breakdown even at low molding pressures

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The composite additive composition works synergistically to provide both structural integrity at low pressure and rapid disintegration. The cellulosic polymer provides binding at low compression while the superdisintegrant ensures quick breakdown, resolving the contradiction between hardness and disintegration speed

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

This approach allows for the production of orally disintegrating tablets with higher moldability, achieving higher tablet hardness at the same tableting pressure or the same hardness at lower pressure, thereby improving their disintegrability and manufacturing efficiency.

Implementation Method 1

a swellable water-insoluble polymer

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Implementation Method 2

a swellable water-insoluble polymer selected from the group consisting of crospovidone and croscarmellose sodium

Methodology Applied
Scientific EffectSwelling:

Implementation Method 3

a (meth)acrylic polymer and/or a cellulosic polymer... enhances tablet hardness while maintaining a short disintegration time

Methodology Applied
Scientific EffectAdhesion: Adhesive

Data Source

PatentUS20250195417A1Additive composition for orally disintegrating tablet
Publication Date: 2025.06.19 DAICEL CORP
  • US20250195417A1 patent drawing
  • US20250195417A1 patent drawing
  • US20250195417A1 patent drawing

AI summary

The present disclosure provides an additive formulation for an orally disintegrating tablet containing (A) an excipient, (B) a crystalline cellulose, (C) a swellable water-insoluble polymer, and (D) (D1) a (meth)acrylic polymer and/or (D2) a cellulosic polymer.