Fecha registrada: March 30 2017

Duration: 44 minutes 08 seconds

In this webinar, we explain how Malvern and PANalytical’s unique range of physicochemical analysis techniques can be used to accelerate the development of oral solid dose products, reducing the time to market for new complex generics.

Oral solid dose (OSD) drug products represent the largest class of products sold by the pharmaceutical industry, and as a result represent a significant opportunity for generic companies. Within this, products which have a modified or sustained release profile represent a significant challenge, as deformulation of these requires specific knowledge of the physicochemical properties of the active pharmaceutical ingredient (API) and any functional excipients present within the formulation.

We’ll explain how the range of measurement solutions from Malvern and PANalytical enable critical material attributes such as particle size, shape, structure and composition to be measured, aiding deformulation and rapid formulation development for complex oral solid dose products.
Table of contents
1. Welcome
00:13
2. Introduction
00:50
3. Complex generics: Understanding and optimising the performance of Oral Solid Dose Drug ProductsApplication of physicochemical characterisation methods in OSD product development
01:22
4. Complex generics: Understanding and optimising the performance of Oral Solid Dose Drug ProductsApplication of physicochemical characterisation methods in OSD product development
01:22
5. Proposed OSD deformulation workflow
03:41
6. Critical material properties for OSD
01:12
7. Possible development timeframe
01:53
8. Complex Generic Products
01:39
9. The FDA sets different equivalence requirements dependant on the RLD product complexity
01:42
10. Malvern PANalytical measurement solutions
01:23
11. Morphologically Directed Raman Spectroscopy can provide particle size, shape and chemical ID data
01:15
12. Morphologically Directed Raman Spectroscopy can provide particle size, shape and chemical ID data
00:25
13. MDRS measures component specific size and shape distributions in support of deformulation and IVBE studies
00:18
14. MDRS measures component specific size and shape distributions in support of deformulation and IVBE studies
00:18
15. MDRS measures component specific size and shape distributions in support of deformulation and IVBE studies
00:30
16. Oral solid dose: deformulation and IVBE
01:41
17. Bioavailability relates to particle size and solid form
02:20
18. Complex product deformulation using MDRS
01:01
19. Complex product deformulation using MDRS
00:59
20. Complex product deformulation using MDRS
00:49
21. Detecting the presence of different API polymorphs
01:06
22. Linking dissolution rate to particle shape measurements
00:30
23. Linking dissolution rate to particle shape measurements
01:10
24. Understanding the manufacturing process used for the active pharmaceutical ingredient
00:16
25. Understanding the manufacturing process used for the active pharmaceutical ingredient
01:00
26. HPMCAS excipient screening using SEC
02:44
27. Hydroxy ethyl cellulose excipient selection
02:02
28. Excipient grade selection
00:56
29. Conclusion: the OSD deformulation workflow
00:55
30. Thank you for your attentionAny questions?
07:57
31. Contact Information
00:39