During specific API Process Development stages, the primary step in powder processing is milling, which involves reducing large particles to smaller ones for a range of processability, bioavailability, reactivity, and safety-related considerations. The drug's efficacy and its capacity to deliver the API to the targeted site in the body at the right pace and concentration are both influenced by particle size distribution (PSD). This is an exact science since the ultimate result will be greatly impacted by the production of too-fine or not-fine-enough powder.
Overheating, oxidation, powder bridging, sieve obstructions, and poor flowability problems are frequently experienced during milling and material handling. In most cases, the necessary physical qualities of the formulation can be obtained by adjusting a wide range of process parameters.