Effects of baffle configuration and tank size on spherical agglomerates of dimethyl fumarate in a common stirred tank.

To pave the way for technology transfer and scale up of the spherical agglomeration (SA) process for dimethyl fumarate, effects of the US, European and Kawashima type baffles and 0.5, 2.0 and 10 L-sized common stirred tank were studied. It was found that the particle size distribution varied significantly. However, the size-related properties such as dissolution profile and flowability of agglomerates from the same size cut after sieving could remain unchanged. The interior structure-related properties such as particle density and mechanical property of agglomerates upon baffle change and scale up from the same size cut were decayed and the agglomerates could become denser and stronger by prolonged maturation time. To maintain the same size distribution, agglomerates from any batch could have been separated and classified by sieving and then blended back together artificially by the desired weight% of each cut.