Influence of fill factor variation in high shear granulation on the post granulation processes: Compression and tablet properties

• Granulation fill factor affects tablet mechanical properties and drug distribution.
• The tablets from large batches were weaker and had a faster dissolution rate.
• Drug distribution in tablets is correlated to the distribution of drug in granules.
• Tablets from larger batches show greater variation than to those from smaller batches.

This paper describes an investigation of the effect of fill factor; on the compaction behaviour of the granules during tabletting and hence mechanical properties of tablets formed. The fill factor; which is the ratio of volume of wet powder material to vessel volume of the granulator, was used as an indicator of batch size. It has been established previously that in high shear granulation the batch size influences the size distribution and granule mechanical properties [1]. The work reported in this paper is an extension to the work presented in [1], hence granules from the same batches were used in production of tablets. The same tabletting conditions were employed during tabletting to allow a comparison of their properties. The compaction properties of the granules are inferred from the data generated during the tabletting process. The tablet strength and dissolution properties of the tablets were also measured. The results obtained show that the granule batch size affects the strength and dissolution of the tablets formed. The tablets produced from large batches were found to be weaker and had a faster dissolution rate. The fill factor was also found to affect the tablet to tablet variation of a non-functional active pharmaceutical ingredient included in the feed powder. Tablets produced from larger batches show greater variation compared to those from smaller batches.

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