Predicting physical properties of pharmaceutical compacts using focused beam reflectance measurement (FBRM)

Abstract

Fluid bed granulation is a dominant method used to produce granules in the pharmaceutical industry. However, controlling the various process parameters is still challenging and granule product quality has further impacts on the tableting process and final tablet quality. Focused beam reflectance measurement (FBRM) was implemented inside the vessel of a fluid bed granulator as a tool for monitoring in-line the particle growth during the granulation process. The main objective of our study was to investigate the relationship between the FBRM measurements of the granules with the physical properties of the compacted granules (tablets). Fifteen granulation experiments were performed under different process parameters in order to vary the dimension of the granules. After granulation, the mean granule size was measured using sieve analysis. Then, the granules were compacted using an instrumented compaction simulator in order to simulate high-speed tableting conditions. The breaking force, disintegration time, compactibility and compressibility of the tablets were analyzed. The results showed that granule size has a powerful influence on the physical properties of the final tablets and, thus, on the quality of the tablets. However, the prediction of those properties exhibited its dependency on the method used to determine particle size.