A novel approach to minimize loss of compactibility in a dry granulation process using superdisintegrants

Aug. 7, 2022, midnight - by Maarten Jaspers , Timo P. Roelofs , Pauline H.M. Janssen , Robin Meier , Bastiaan H.J. Dickhoff

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Roller compaction for dry granulation is gaining popularity as a method for producing oral solid dosage forms. The process offers simplicity compared to wet granulation and operates inherently in a continuous manner. However, a common challenge with dry granulation is the diminished compactibility of the granules in comparison to the original powders. In this study, we introduce an innovative approach to mitigate the loss of compactibility during dry granulation. Our method involves the intra-granular addition of a superdisintegrant, which effectively reduces the loss of compactibility in granules based on anhydrous lactose produced through roller compaction. This reduction is attributed to a decrease in granule hardness, facilitating enhanced granule fragmentation during tablet compression. The heightened degree of fragmentation exposes more lactose surface area for bonding, ultimately improving tablet strength. The findings presented herein illustrate how intra-granular superdisintegrants can be strategically employed to minimize the loss of compactibility in a dry granulation formulation.

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