Problems in determining particle sizes during clinical development

This White Paper from Denmark’s particle properties specialist laboratory, Particle Analytical, explores particle analysis in clinical development and in particular commonly encountered pitfalls in determination of particle sizes.

The paper reviews different methods for determining particle size, and in particular the implications of applying various mathematical transformation models (Mie or Fraunhofer) to the data obtained from laser diffraction. The paper shows how using a transformation based on incorrect particle Refractive Index (RI) can produce very different particle size distribution results.

Thus, Particle Analytical demonstrates the dangers of using default RI values within Mie transformation modeling software programs and suggests a safer methodology for determining particle size and distribution accurately based on actual RI values or the Fraunhofer model.