Fecha registrada: February 09 2016
Duration: 35 minutes 10 secondsThe 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
2. Particle Characterization for Oral Solid Dose Formulations
3. What should be considered when testing new drug products?
5. Dissolution: what should I consider?
6. Stability: what should I consider?
7. Stability: what should I consider?
8. Content uniformity: what should I consider?
9. How should I measure?
10. What should I report?
11. Case study: controlling powder flowability
12. Case study: controlling powder flowability
13. Case study: detecting instability during storage
14. Case study: detecting instability during storage
15. Case study: understanding dissolution behaviour
16. Case study: predicting processability
17. Case study: predicting processability
18. Case study: predicting processability
19. Case study: predicting processability
21. Thank you for your attentionAny questions?
22. Contact Information