Orally Disintegrating Tablet With Organic Acid Coating
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Solution Overview
Problem
Intraorally disintegrating tablets face challenges in simultaneously achieving taste masking, disintegration, and controlled dissolution properties, with existing formulations often failing to maintain a stable disintegration property immediately after preparation.
Innovation Solution
Compression molding of active ingredient-containing core particles coated with a water insoluble or enteric polymer, along with an organic acid such as ascorbic acid or citric acid, to enhance taste masking and disintegration while maintaining a good dissolution profile.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a coating layer comprising water insoluble polymer and/or enteric polymer is used, then taste masking property and dissolution property are improved, but disintegrating property immediately after preparation deteriorates
Solution Approach 1:
The patent applies preliminary action by incorporating a disintegrant in the coating layer before tablet formation. This pre-positioned disintegrant is prepared in advance to ensure rapid disintegration occurs immediately after tablet preparation, counteracting the potential deterioration of disintegrating properties that would otherwise result from using polymer coatings for taste masking and controlled dissolution.
2Adaptability or versatility
If multiple properties (taste masking, disintegration, controlled dissolution) are simultaneously targeted, then formulation complexity increases, but quality stability deteriorates
Solution Approach 1:
The patent merges multiple functions into a single integrated coating layer that simultaneously provides taste masking (through polymer coating), disintegration (through incorporated disintegrant), and controlled dissolution (through water insoluble/enteric polymer). This consolidation of multiple functions into one coating system maintains quality formulation stability while achieving all desired properties.
Solution Approach 2:
The coating layer is formulated as a composite material combining water insoluble polymer, enteric polymer, and disintegrant in specific proportions. This composite structure enables the coating to simultaneously provide taste masking, rapid disintegration, and controlled dissolution properties while maintaining stable and reproducible formulation quality.
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 approach results in intraorally disintegrating tablets that effectively mask bitterness and irritation, with improved disintegration and dissolution properties, retaining performance immediately after preparation.
Implementation Method 1
an intraorally disintegrating tablet... comprising an organic acid as a disintegration accelerator
Implementation Method 2
a property of masking unpleasant tastes such as bitterness derived from the active ingredient and an irritating sensation
Implementation Method 3
a dissolution property intended for the intestinal tract... an enteric polymer such as a methacrylic acid copolymer
Data Source
AI summary
Disclosed is an orally disintegrating tablet which masks bitterness, dissolves well, and which permanently retains good oral disintegration properties immediately following manufacture. The disclosed orally disintegrating tablet is formed by compression-molding an organic acid together with particles comprising active ingredient-containing nuclear particles covered by a layer containing water-insoluble polymers and/or enteric polymers.