Mannitol-CMC Co-mixture for Rapid Disintegration Tablets
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Solution Overview
Problem
Current tablet matrices for rapid release of active compounds from solid oral medicaments face challenges in achieving high hardness while ensuring rapid disintegration and pleasant taste, with existing mannitol preparations being complex or inadequate in pharmaceutical formulation properties.
Innovation Solution
A co-mixture of 90-98% sprayed mannitol and 10-2% crosslinked sodium carboxymethylcellulose, characterized by a BET surface area of greater than 1.5 m2/g, bulk density between 0.45-0.60 g/ml, and angle of repose between 30-38°, allowing for direct tableting with high hardness and rapid disintegration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a tablet matrix is designed to provide high tablet hardness through compression, then the tablets become easier to handle and store, but the disintegration time increases and rapid release of active compound is compromised
Solution Approach 1:
The patent uses a composite matrix system combining mannitol (provides hardness and structural integrity) with crosslinked sodium carboxymethylcellulose (provides rapid disintegration). This composite approach allows simultaneous achievement of high tablet hardness (>250N) and rapid disintegration (<70 seconds) by leveraging the complementary properties of each material component.
Solution Approach 2:
The patent optimizes specific parameters including BET surface area (>1.5 m²/g), bulk density (0.45-0.60 g/ml), and angle of repose (30-38°) to achieve the desired balance between hardness and disintegration. By controlling these physical parameters, the matrix provides both mechanical strength and rapid moisture-driven disintegration capability.
2Duration of action of moving object
If a tablet matrix is designed for rapid disintegration and release of active compounds, then the release speed improves, but the tablet hardness decreases making handling difficult
Solution Approach 1:
The composite system of mannitol and crosslinked sodium carboxymethylcellulose enables simultaneous achievement of high tablet hardness (>250N) and rapid disintegration (<70 seconds) by leveraging the complementary properties of each material component.
Solution Approach 2:
The patent optimizes specific parameters including BET surface area (>1.5 m²/g), bulk density (0.45-0.60 g/ml), and angle of repose (30-38°) to achieve the desired balance between hardness and disintegration. By controlling these physical parameters, the matrix provides both mechanical strength and rapid moisture-driven disintegration capability.
3Duration of action of moving object
If existing mannitol preparations are used to achieve rapid disintegration, then the disintegration property improves, but the structure becomes very complex and processing becomes difficult
Solution Approach 1:
The patent specifies precise parameter ranges including BET surface area (>1.5 m²/g), bulk density (0.45-0.60 g/ml), and angle of repose (30-38°) that simplify the matrix structure while maintaining rapid disintegration performance. These parameter controls enable straightforward industrial processing without complex granulation steps.
Solution Approach 2:
The patent employs crosslinked sodium carboxymethylcellulose as a localized disintegrant component within the mannitol matrix, providing rapid disintegration functionality only where needed without complicating the overall matrix structure. This targeted approach maintains simplicity in the bulk mannitol formulation.
4Duration of action of moving object
If a co-mixture with high BET surface area is used to increase disintegration rate, then the disintegration time decreases, but the manufacturing precision requirements increase
Solution Approach 1:
The patent specifies precise parameter ranges including BET surface area (>1.5 m²/g), bulk density (0.45-0.60 g/ml), and angle of repose (30-38°) that simplify the matrix structure while maintaining rapid disintegration performance. These parameter controls enable straightforward industrial processing without complex granulation steps.
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 co-mixture enables the production of tablets with hardness greater than 250N and disintegration time less than 70 seconds, maintaining low friability and rapid disintegration over a broad hardness range, suitable for various pharmaceutical formulations.
Implementation Method 1
a tablet matrix which disintegrates very rapidly, has a pleasant taste and is simple to process
Implementation Method 2
After compression at a pressing force of 20 kN, it is possible to obtain tablets having hardnesses of >250N
Data Source
AI summary
The present invention relates to a novel directly compressible matrix for the production of tablets which disintegrate rapidly in the presence of moisture, in particular in the mouth.