Abstract
The effects of a high shear blending process on lactose α-monohydrate have been investigated and important process parameters identified. Total energy input (kJ/kg), blade design and the conditions in which lactose was stored prior to blending were found to have the most significant effect on the particle size distribution, which may affect final formulation performance. The power settings used during blending, equipment temperature and humidity of the headspace above the powder were not found to have a significant effect. A simple energy balance model has also been produced that predicts the temperature of the blend with time. Although the temperature has no effect on the particle size distribution, it will affect the relative humidity in the blend which is known to have an impact on the drug-lactose interaction.