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Startseite » DC excipient » 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

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

24. September 2020
Tablet properties of pre- and post-storage tablets consisting of different mannitol grades

Tablet properties of pre- and post-storage tablets consisting of different mannitol grades

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.

Download the full publication here: 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

or continue reading here: 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.

Direct compaction grades of mannitol tested in this study

Mannitol GradesManufacturerManufacturing MethodCrystalline Form
Mannit QMitsubishi Life Science InstituteSpray-dryingβ
Pearlitol 100SDRoquetteSpray-dryingα, β
Pearlitol 200SDRoquetteSpray-dryingα, β
Pearlitol 300DCRoquetteGranulationβ
Pearlitol 400DCRoquetteGranulationβ
Pearlitol 500DCRoquetteGranulationβ
Parteck M100MerckSpray-dryingβ
Parteck M200MerckSpray-dryingβ
Granutol FFreund CorporationGranulationβ
Granutol SFreund CorporationGranulationβ
Granutol RFreund CorporationGranulationβ
Mannogem EZ Spray DriedSPI PharmaSpray-dryingα, β
Mannogem XLSPI PharmaSpray-dryingα, β
Mannogem 2080SPI PharmaGranulationβ
Mannogem AGSPI PharmaGranulationβ
Tags: excipientsformulation

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