날짜 기록: June 06 2019
Duration: 39 minutes 28 seconds
Setting meaningful and realistic specifications for pharmaceutical product Critical Material Attributes (CMAs) is an important in ensuring a product meets its target performance profile. Within this, the particle size and size distribution of the Active Pharmaceutical Ingredients (APIs) and excipients present within a product formulation are often considered to be important. However, why is this the case and what guidance is available to help decide whether a method selected for particle size analysis is appropriate?
This webinar series we will consider why particle size is important for pharmaceutical products and how answering this question can lead to the specification of a realistic method.
In this first presentation we will consider why a particle size specification may be required. We’ll review the guidance provided in ICH Q6A, which recommends that formulation developers consider how product bio-availability, uniformity, stability and process ability may be impacted by particle size changes. We will then consider how techniques such as laser diffraction and automated image analysis can aid formulation developers in material selection and in understanding the impact of formulation processing operations on likely product performance.
The second seminar in the series will consider how an appropriate method for particle size analysis can be developed based on an understanding of why particle size analysis is important.