Date recorded: July 12 2016

Duration: 39 minutes 11 seconds

In a recent newsletter, the US FDA highlighted the important role Morphologically-Directed Raman Spectroscopy (MRDS) can play in supporting the development of generic drug products. The component-specific particle size and shape distribution data generated by this technique can aid sponsors with pinpointing the formulation characteristics and possible manufacturing route used for a Reference Listed Drug (RLD) product, and provides the in vitro data required to support bioequivalence studies. This webinar will consider the workflow associated with RLD deformulation and will introduce the technique of MDRS and its application in developing complex generics including Oral Solid Dose (OSD), Topical and OINDP formulations.
Table of contents
1. Welcome
01:30
2. The deformulation workflow needs to consider the RLD product API and excipient properties
04:18
3. The deformulation workflow needs to consider the RLD product API and excipient properties
00:41
4. Morphological imaging enables particle classification on the basis of the size and shape of particles
01:58
5. Morphologically-Directed Raman Spectroscopy extends this capability by identifying particles
00:50
6. The MDRS measurement workflow uses size and shape classifications to target Raman measurements
00:50
7. The MDRS measurement workflow uses size and shape classifications to target Raman measurements
00:42
8. The MDRS measurement workflow uses size and shape classifications to target Raman measurements
00:55
9. The FDA has recently recognized the role MDRS has in supporting in vitro bioequivalence studies
01:27
10. Case Study: characterization of nasal spray suspension formulations
02:25
11. Case Study: characterization of nasal spray suspension formulations
00:36
12. MDRS extends image analysis using Raman spectroscopy to identify different materials
00:52
13. The analysis speed is optimized by defining a target particle size or shape range for Raman analysis
01:10
14. Components are identified by spectral matching enabling API-specific data to be generated
00:45
15. Components are identified by spectral matching enabling API-specific data to be generated
00:44
16. Case study: measuring the size and shape of two APIs in a dry powder inhaler formulation
01:22
17. Case study: measuring the size and shape of two APIs in a dry powder inhaler formulation
00:47
18. Case study: measuring the size and shape of two APIs in a dry powder inhaler formulation
01:00
19. Case study: measuring the size and shape of two APIs in a dry powder inhaler formulation
01:04
20. Case study: measuring the size and shape of two APIs in a tablet formulation
01:10
21. Case study: measuring the size and shape of two APIs in a tablet formulation
00:08
22. Case study: measuring the size and shape of two APIs in a tablet formulation
01:10
23. Case study: characterizing complex emulsions and topical formulations
00:35
24. Case study: characterizing complex emulsions and topical formulations
00:49
25. Case study: characterizing complex emulsions and topical formulations
00:40
26. Case study: characterizing complex emulsions and topical formulations
00:43
27. Case study: quantifying the proportion of different polymorphs within a blend
01:06
28. Case study: understanding the API manufacturing process for a tablet formulation
01:13
29. Conclusion
01:07
30. Thank you for your attentionAny questions?Please type your questions in using the Q&A panel on the right side of your screen
00:43
31. Thank you
05:51