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Article

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

1
Formulation Development Department, Development & Planning Division, Nichi-Iko Pharmaceutical Co., Ltd., 205-1, Shimoumezawa Namerikawa-shi, Toyama 936-0857, Japan
2
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Malaya, Kuala Lumpur 50603, Malaysia
3
Laboratory of Pharmaceutical Technology, Graduate School of Medicine and Pharmaceutical Science for Research, University of Toyama; 2630 Sugitani, Toyama-shi, Toyama 930-0194, Japan
*
Author to whom correspondence should be addressed.
Pharmaceutics 2020, 12(9), 886; https://doi.org/10.3390/pharmaceutics12090886
Received: 21 August 2020 / Revised: 10 September 2020 / Accepted: 17 September 2020 / Published: 18 September 2020
(This article belongs to the Section Physical Pharmacy and Formulation)
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. View Full-Text
Keywords: excipient; storage stability; tablet; mannitol; Kohonen self-organizing map; Elastic net regression excipient; storage stability; tablet; mannitol; Kohonen self-organizing map; Elastic net regression
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MDPI and ACS Style

Kosugi, A.; Leong, K.H.; Urata, E.; Hayashi, Y.; Kumada, S.; Okada, K.; Onuki, Y. 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. Pharmaceutics 2020, 12, 886. https://doi.org/10.3390/pharmaceutics12090886

AMA Style

Kosugi A, Leong KH, Urata E, Hayashi Y, Kumada S, Okada K, Onuki Y. 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. Pharmaceutics. 2020; 12(9):886. https://doi.org/10.3390/pharmaceutics12090886

Chicago/Turabian Style

Kosugi, Atsushi, Kok H. Leong, Eri Urata, Yoshihiro Hayashi, Shungo Kumada, Kotaro Okada, and Yoshinori Onuki. 2020. "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" Pharmaceutics 12, no. 9: 886. https://doi.org/10.3390/pharmaceutics12090886

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