Abstract
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.
Highlights
In manufacturing tablet products, a wide range of excipients are incorporated into the dosage form as well as the active pharmaceutical ingredients (APIs)
The spray-dried mannitol grades correspond to Mannit Q (MQ), 100SD, 200SD, EZ, XL, M100, and M200, while granulated grades were 300DC, 400DC, 500DC, 2080, AG, Granutol F (GF), Granutol S (GS), and Granutol R (GR) [4,6,7]
They are different in terms of crystalline forms: namely, 100SD, 200SD, EZ, and XL were a mixture of α and β crystalline forms, while the other grades consisted of the β form only
Summary
A wide range of excipients are incorporated into the dosage form as well as the active pharmaceutical ingredients (APIs). Fillers are excipients to increase dosage form, volume, or weight, and they are added to tablet formulations for the manufacture of properly sized products for easy handling. They play an important role in improving tablet processability. Mannitol provides patients with a pleasant cool feeling when it dissolves in the mouth These properties are advantageous for a tablet filler, especially orally disintegrating tablets (ODTs). Mannitol is more chemically inert than lactose, because mannitol is not accompanied by the Maillard reaction, which can occur between lactose and amine functional groups, in APIs, which leads to their degradation [4,5] It can be used as an alternative filler to lactose
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