Зафиксированная дата: September 12 2019

Duration: 47 minutes 51 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.

This webinar series will consider the guidance available regarding polymorph and crystallinity analysis for pharmaceutical products and how appropriate methods can be developed using the technique of X-Ray Powder Diffraction (XRPD).

In this first presentation we will discuss why a polymorph specification may be required. We’ll review the guidance provided in ICH Q6A, which recommends that formulation developers consider how product bioavailability, uniformity, stability and processability may be impacted by structural changes. We will then consider how XRPD can aid formulation developers in material selection and in understanding the impact of formulation processing operations on product performance.

The second webinar in the series will consider how an appropriate method for XRPD analysis can be developed and how various sample preparation techniques can influence it.

The final webinar will focus on the advanced analysis methods available using an XRPD system which can help with understanding the distribution of components within pharmaceutical dosage forms and can also provide a means of describing amorphous materials.

Table of contents
1. Focus on PharmaSolid Form Analysis: Advance Your Analysis
03:59
2. Why Solid Form Analysis?
00:50
3. Why Solid Form Analysis?
02:12
4. Why Solid Form Analysis?
02:08
5. How does Quality by Design (QbD) help?
00:46
6. Applying QbD to drug product development
02:16
7. What parameters can be considered CMAs?
00:34
8. What parameters can be considered CMAs?
00:26
9. What can be considered a CMA?
00:28
10. What can be considered a CMA?
00:15
11. When is solid form considered a CMA?
01:35
12. When is solid form considered a CMA?
02:03
13. Solutions for solid form analysis
02:19
14. Solutions for solid form analysis
01:18
15. Crystallization monitoring
01:19
16. Industry need for on-line monitoring
00:31
17. Applications for in situ studies
00:50
18. DL-Alanine crystallization at pH = 6.1
01:52
19. Crystallinity change after tablet stress (T)
01:00
20. Why study polymorphs?
01:50
21. Case study: oral solid dose products
01:14
22. Polymorph Identification
00:45
23. 1. Comparison with multiple reference patterns
00:33
24. 1. Automatic identification using HighScore
01:17
25. 2. Polymorph identification – indexing method
00:25
26. 2. Unit cell search & indexing – Example
00:36
27. 2. Fitting with known unit cell parameters
00:27
28. 3. Comparison to Calculated pattern
01:10
29. 3. Rietveld refinement
01:08
30. What are the benefits of asking ‘why?’
01:44
31. Questions & Answers
09:21
32. Thank you for your attention!
00:40