Date recorded: February 09 2016

Duration: 35 minutes 10 seconds

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.
Table of contents
1. Particle Characterization for Oral Solid Dose Formulations
01:16
2. Particle Characterization for Oral Solid Dose Formulations
01:34
3. What should be considered when testing new drug products?
01:01
4. Untitled
01:18
5. Dissolution: what should I consider?
01:07
6. Stability: what should I consider?
00:55
7. Stability: what should I consider?
02:12
8. Content uniformity: what should I consider?
01:09
9. How should I measure?
01:51
10. What should I report?
01:28
11. Case study: controlling powder flowability
01:50
12. Case study: controlling powder flowability
01:07
13. Case study: detecting instability during storage
00:43
14. Case study: detecting instability during storage
01:09
15. Case study: understanding dissolution behaviour
02:11
16. Case study: predicting processability
01:09
17. Case study: predicting processability
01:19
18. Case study: predicting processability
01:45
19. Case study: predicting processability
01:44
20. Conclusions
01:27
21. Thank you for your attentionAny questions?
06:13
22. Contact Information
00:42