Date d'enregistrement: October 10 2019

Duration: 01 hours 01 minutes 49 seconds

Setting meaningful and realistic specifications for pharmaceutical product Critical Material Attributes (CMAs) is an important in ensuring a product meets its target performance profile. Within this, the polymorphism and crystallinity of the Active Pharmaceutical Ingredients (APIs) and excipients present within a product formulation are crucial. Presence of an undesired polymorph could lead to a reduction in therapeutic benefit, due to changes in API solubility, and may even cause an adverse effect to the patient. Polymorph selection, and conformation of polymorphic stability over time, is therefore vital. This becomes even more important when an amorphous for of the API is selected to improve solubility, as unexpected crystallization of an insoluble form can be fatal.

In this third and final webinar in the series, we will focus on the advanced analysis methods available using an XRPD system. These methods can help with understanding the following aspects of pharmaceutical products:

- Stability of a formulation over time and as a function of temperature and/or relative humidity;
- Distribution of components within pharmaceutical solid dosage forms;
- Influence of different manufacturing methods on the internal and surface structure for solid dosage forms;
- Amorphous content and the structure of amorphous materials, in support of stability studies and detailed product specification.

Table of contents
1. Focus on PharmaSolid Form Analysis: Extend your understanding
04:32
2. Why Solid Form Analysis?
01:17
3. USP<941> guidance for X-ray diffraction
00:59
4. Outline
01:13
5. In situ stability tests
00:27
6. Example 1: α-α-Trehalose
01:00
7. Example 1: α-α-Trehalose
02:18
8. Example 1: α-α-Trehalose
01:02
9. Example 2: Protein in situ humidity studies
02:02
10. Example 2: Hen Egg White Lysozyme (HEWL)
01:42
11. Example 2: HEWL in situ humidity study
02:27
12. High-throughput screening (HTS)
00:29
13. HTS with Empyrean
02:03
14. Data treatment with HighScore Plus
01:53
15. Crystallization plates integration
01:30
16. Example 1: Bovine insulin
00:32
17. Example 2: Anthranilic acid
01:23
18. Amorphous materials: quantification and structure
00:26
19. Quantification – low amorphous content
01:04
20. Quantification from X-ray diffraction data
02:59
21. Partial Least-Squares Regression (PLSR)
01:44
22. Quantification – low amorphous content
01:05
23. Quantification – low amorphous content
01:22
24. How X-ray diffraction sees the world
00:32
25. How X-ray diffraction sees the world
00:27
26. How X-ray diffraction sees the world
00:23
27. Pair-Distribution Function (PDF)
01:46
28. PDF analysis
00:47
29. Industrial interest
01:05
30. Example 1
00:50
31. Example 2
00:42
32. Example 2 – amorphous API
00:41
33. Example 2 – amorphous API
01:10
34. Example 2 – amorphous API
00:33
35. Internal and surface structure of solid dosage forms
00:34
36. Computed Tomography (CT)
01:11
37. API Distribution
01:45
38. QC: Batch comparison
01:20
39. Wall thickness analysis
02:16
40. Summary
01:05
41. Summary
00:47
42. Untitled
00:10
43. Thank you for your attention!
08:16