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Updated: Jun 11, 2026

Formation of Dispersible Taohong Siwu Tablets
Published on: February 3, 2023
Development of a new disintegration method for orally disintegrating tablets
Ryo Kakutani1, Hiroyuki Muro, Tadashi Makino
1Novel Pharmaceutical Labs, Kyoto Pharmaceutical Industries, Ltd., Kyoto, Japan. kakutani@kyoto-pharm.co.jp
A new Kyoto-model disintegration (KYO) method accurately predicts oral disintegrative properties of orally disintegrating tablets (ODTs). This physical assessment method correlates well with human sensory tests, aiding ODT development and quality control.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
Background:
- Assessing oral disintegrative properties is crucial for orally disintegrating tablets (ODTs).
- A simple, physical method for evaluating ODT disintegration is needed for development and quality control.
Purpose of the Study:
- To develop and validate a new disintegration test method (KYO method) for orally disintegrating tablets.
- To assess the KYO method's ability to predict oral disintegration properties and its correlation with human sensory perception.
Main Methods:
- Developed the Kyoto-model disintegration (KYO) method, classifying ODTs by water permeability and using a standardized water volume.
- Evaluated 25 commercial prescription ODTs using the KYO method and compared results with a human sensory test.
- Assessed the method's ability to detect time-dependent changes in ODT disintegration.
Main Results:
- The KYO method showed a good correlation with human sensory test results for 25 ODT samples.
- The KYO method effectively evaluated time-dependent changes in ODT disintegration.
- The Japanese Pharmacopeia disintegration test did not correlate with the human sensory test.
Conclusions:
- The KYO method accurately reflects the disintegration characteristics of ODTs in the oral cavity.
- The KYO method is a practical tool for the development and quality control of orally disintegrating tablets.
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