Determining the effect of granule particle size on tablet properties

Abstract

During the formulation of tablets and other solid dosage forms, it involves processing powder beds which are heterogeneous in their particle size distribution. The cause of this study was to investigate the effect of granule particle size on the hardness and friability of tablets using selected batches of tablets. The granule particles were formed by the process of wet granulation in the rapid mixer and granulator and dried using a fluidized bed equipment. The granules where then sized using the sieve technology method, the sieve sizes used included mesh size12mm,16mm,20mm and 30mm for the tablets. The resulting sized granules were blended and then taken for compression into tablets using a rotary compression machine. 10 tablets for each granule size where sampled and used for checking hardness, this was done in triplicates for each granule size. The results indicated that when the granule size decreased from 16mm-30mm, the friability value for both tablets increased. It was granule size 12mm & 16mm that gave friability results below the acceptable value of 1% while 20mm and 30mm size gave friability above one. Sieve size 12mm gave the best friability value of 0.27% of Lumartem while for Efavil 600, it was sieve size 16mm that gave the best friability of 0.26%. The hardness of the tablets decreased as the sieve size reduced for both tablets. Sieve size 12mm gave a good hardness value for Lumartem as 4.2kg/m which was within the acceptable limits while for Efavil 600 sieve size 16mm gave the best hardness value of 4.3kg/m which also was within the limits of (4-8) kg/m. This study has therefor showed that varying the granule size of tablets can affect some of the physical properties of tablets. This means that the granule sizes should be controlled during tablet processing in order to avoid weight and content variation while ensuring that only tablets with desirable mechanical characteristics are formed.