Bench to batch: Linking pharmaceutical powder flow characterisation, intermediate bulk container discharge and video observations

Abstract

Five well known excipients and a model drug substance with varied particle properties and bulk behaviour were chosen for the study. Based on the results APAP, NaCMC-XL, mannitol and DCPA were selected for a design to understand the impact of different blends. Two pilot scale unvented IBCs were used in the study. The IBC discharge rates were measured using a catch balance and the mode of flow and powder behaviour inside the IBC was recorded using a camera. The videos inside the IBC showed that regardless of flow mode, for powder to flow from the IBC an air burst was necessary. This was similar to observations when emptying water from a bottle. The extent of the air flow inside the IBC was strong and could possibly result in fluidisation segregation. The discharge curves of 15° and 30° hopper half angles were very similar, which was explained by the vertical air movement in the steeper hopper, which reduces the particle acceleration. Several good indicators of flow/no flow in the IBCs were found. However, for predicting the discharge rate there was a linear correlation between flow through an orifice and IBC discharge rate.