The purpose of this work is to demonstrate a process for the alteration of the shape of needle shaped crystals of an active pharmaceutical ingredient (API) using a combination of wet milling and temperature cycling. The effect upon powder handling metrics of the shape alteration approach was quantified and the impact upon a subsequent roller compaction process step demonstrated. Methods Particle shape was altered through a combination of wet milling and temperature cycling. Image analysis was...
The aim of the study was to optimize a tablet coating process for a continuous manufacturing line. High throughputs should be achieved while inter-tablet coating variability should be as small as possible. Drug-free cores were coated with a colored suspension. All processes were monitored in-line with Raman spectroscopy. A statistical design of experiment was performed to find optimum process parameters.