Fecha registrada: May 20 2015

Duration: 52 minutes 20 seconds

The development of oral solid dose (OSD) products requires a knowledge of how the physical properties of the excipients and active pharmaceutical ingredients (APIs) present within a formulation affect product performance. This requires access to relevant technologies for measurement properties such as particle size, size distribution and particle shape. In this webinar, we will introduce the workflow for OSD formulation and will explore how Morphologically Directed Raman Spectroscopy and laser diffraction can aid formulation developers in material selection and in understanding the impact of formulation processing operations.
Table of contents
1. Welcome
03:04
2. Application of particle size and shape analysis in Oral Solid Dose product formulation
00:51
3. Applying QbD to OSD development requires a full understanding of a product and its performance
01:28
4. Guidance is Available in ICH Q6A Regarding When Particle Size is a Critical Quality Attribute
01:31
5. Excipient and API size and shape data can aid OSD product and process understanding
01:02
6. Excipient and API size and shape data can aid OSD product and process understanding
00:33
7. Laser diffraction calculates particle size distributions by measuring particle light scattering intensity
01:11
8. Laser diffraction offers many advantages for pharmaceutical particle size measurements
01:31
9. Case study: using laser diffraction to specify and detect changes in excipient blends
01:32
10. Case study: using laser diffraction to monitor API particle size distributions during scale-up
00:56
11. Case study: using laser diffraction to monitor API particle size distributions during scale-up
00:56
12. Case study: using laser diffraction to monitor API particle size distributions during scale-up
00:50
13. Morphologically Directed Raman Spectroscopy can provide particle size, shape and chemical ID data
01:32
14. MDRS measures component specific size and shape distributions in support of formulation studies
00:45
15. MDRS measures component specific size and shape distributions in support of formulation studies
00:33
16. MDRS measures component specific size and shape distributions in support of formulation studies
00:33
17. Case study: correlating dissolution performance with API particle shape for a powder formulation
01:49
18. Case study: quantifying the proportion of different polymorphs within a blend
01:07
19. Case study: quantifying the proportion of different polymorphs within a blend
00:40
20. Case study: understanding changes in API cohesively / flowability
00:38
21. Case study: understanding changes in API cohesively / flowability
00:28
22. Case study: understanding changes in API cohesively / flowability
00:54
23. Case study: understanding the impact of API manufacturing process changes
01:05
24. Case study: monitoring process induced API changes with blended formulations
03:20
25. Conclusion and Q&A
21:31
26. Contact Information
02:00