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, 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 Grades | Manufacturer | Manufacturing Method | Crystalline Form |
|---|---|---|---|
| Mannit Q | Mitsubishi Life Science Institute | Spray-drying | β |
| Pearlitol 100SD | Roquette | Spray-drying | α, β |
| Pearlitol 200SD | Roquette | Spray-drying | α, β |
| Pearlitol 300DC | Roquette | Granulation | β |
| Pearlitol 400DC | Roquette | Granulation | β |
| Pearlitol 500DC | Roquette | Granulation | β |
| Parteck M100 | Merck | Spray-drying | β |
| Parteck M200 | Merck | Spray-drying | β |
| Granutol F | Freund Corporation | Granulation | β |
| Granutol S | Freund Corporation | Granulation | β |
| Granutol R | Freund Corporation | Granulation | β |
| Mannogem EZ Spray Dried | SPI Pharma | Spray-drying | α, β |
| Mannogem XL | SPI Pharma | Spray-drying | α, β |
| Mannogem 2080 | SPI Pharma | Granulation | β |
| Mannogem AG | SPI Pharma | Granulation | β |