The particle size and size distribution of the Active Pharmaceutical Ingredients (APIs) and excipients present in Oral Solid Dose (OSD) products are often critical to defining product performance. This is recognized by ICH Q6A, which recommends that formulation developers consider how product bioavailability, uniformity, stability and processability may be impacted by particle size changes, and develop a specification for particle size if required in order to achieve product quality control.

In this webinar we consider the guidance provided in ICH Q6A and introduce the use of image analysis and laser diffraction for particle characterization studies, providing examples of how these techniques can aid formulation developers in material selection and in understanding the impact of formulation processing operations on likely product performance.