Effect of Different Direct Compaction Grades of Mannitol on the Storage Stability of Tablet Properties Investigated Using a Kohonen Self-Organizing Map and Elastic Net Regression Model
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- Atsushi Kosugi
- Formulation Development Department, Development & Planning Division, Nichi-Iko Pharmaceutical Co., Ltd., 205-1, Shimoumezawa Namerikawa-shi, Toyama 936-0857, Japan
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- Kok Hoong Leong
- Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Malaya, Kuala Lumpur 50603, Malaysia
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- Eri Urata
- Laboratory of Pharmaceutical Technology, Graduate School of Medicine and Pharmaceutical Science for Research, University of Toyama; 2630 Sugitani, Toyama-shi, Toyama 930-0194, Japan
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- Yoshihiro Hayashi
- Formulation Development Department, Development & Planning Division, Nichi-Iko Pharmaceutical Co., Ltd., 205-1, Shimoumezawa Namerikawa-shi, Toyama 936-0857, Japan
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- Shungo Kumada
- Formulation Development Department, Development & Planning Division, Nichi-Iko Pharmaceutical Co., Ltd., 205-1, Shimoumezawa Namerikawa-shi, Toyama 936-0857, Japan
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- Kotaro Okada
- Laboratory of Pharmaceutical Technology, Graduate School of Medicine and Pharmaceutical Science for Research, University of Toyama; 2630 Sugitani, Toyama-shi, Toyama 930-0194, Japan
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- Yoshinori Onuki
- Laboratory of Pharmaceutical Technology, Graduate School of Medicine and Pharmaceutical Science for Research, University of Toyama; 2630 Sugitani, Toyama-shi, Toyama 930-0194, Japan
説明
<jats:p>This study tested 15 direct compaction grades to identify the contribution of different grades of mannitol to the storage stability of the resulting tablets. After preparing the model tablets with different values of hardness, they were stored at 25 °C, 75% relative humidity for 1 week. Then, measurement of the tablet properties was conducted on both pre- and post-storage tablets. The tablet properties were tensile strength (TS), friability, and disintegration time (DT). The experimental data were analyzed using a Kohonen self-organizing map (SOM). The SOM analysis successfully classified the test grades into three distinct clusters having different changes in the behavior of the tablet properties accompanying storage. Cluster 1 showed an obvious rise in DT induced by storage, while cluster 3 showed a substantial change in mechanical strength of the tablet including a reduction in the TS and a rise in friability. Furthermore, the data were analyzed using an Elastic net regression technique to investigate the general relationships between the powder properties of mannitol and the change behavior of the tablet properties. Consequently, we succeeded in identifying the crucial powder properties for the storage stability of the resulting tablets. This study provides advanced technical knowledge to characterize the effect of different direct compaction grades of mannitol on the storage stability of tablet properties.</jats:p>
収録刊行物
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- Pharmaceutics
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Pharmaceutics 12 (9), 886-, 2020-09-18
MDPI AG