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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

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, measur...

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Autores principales: Kosugi, Atsushi, Leong, Kok Hoong, Urata, Eri, Hayashi, Yoshihiro, Kumada, Shungo, Okada, Kotaro, Onuki, Yoshinori
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7559487/
https://www.ncbi.nlm.nih.gov/pubmed/32961856
http://dx.doi.org/10.3390/pharmaceutics12090886
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author Kosugi, Atsushi
Leong, Kok Hoong
Urata, Eri
Hayashi, Yoshihiro
Kumada, Shungo
Okada, Kotaro
Onuki, Yoshinori
author_facet Kosugi, Atsushi
Leong, Kok Hoong
Urata, Eri
Hayashi, Yoshihiro
Kumada, Shungo
Okada, Kotaro
Onuki, Yoshinori
author_sort Kosugi, Atsushi
collection PubMed
description 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.
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spelling pubmed-75594872020-10-26 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 Kosugi, Atsushi Leong, Kok Hoong Urata, Eri Hayashi, Yoshihiro Kumada, Shungo Okada, Kotaro Onuki, Yoshinori Pharmaceutics Article 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. MDPI 2020-09-18 /pmc/articles/PMC7559487/ /pubmed/32961856 http://dx.doi.org/10.3390/pharmaceutics12090886 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Kosugi, Atsushi
Leong, Kok Hoong
Urata, Eri
Hayashi, Yoshihiro
Kumada, Shungo
Okada, Kotaro
Onuki, Yoshinori
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7559487/
https://www.ncbi.nlm.nih.gov/pubmed/32961856
http://dx.doi.org/10.3390/pharmaceutics12090886
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