Dry granulation in solid oral formulation: advantages of spray-dried mannitol in roll compaction

September 25, 2025

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The article explores the benefits of spray-dried mannitol as a filler/binder in dry granulation via roller compaction, a technique particularly suited to moisture- and heat-sensitive APIs since it avoids wet granulation and drying steps. Compared to unprocessed mannitol, spray-dried grades deliver improved powder flowability, higher bulk density, and reduced fine particle formation, enhancing tableting performance. Studies show that granules made using spray-dried mannitol consistently exhibit increased specific surface area—especially under higher compaction forces—due to fragmentation of brittle particles, which supports strong tablet tensile strength even at scale. Among mannitol grades evaluated (e.g. PO, GR, EZ, XL), spray-dried XL and EZ showed superior tabletability, though they were more sensitive to high compaction forces than PO and GR. The findings highlight that selecting the optimal mannitol grade based on compaction characteristics helps ensure robust granule quality, consistent flow, and reliable tablet performance in roller compaction-based dry granulation processes.