Focus on Pharma: Solid Form Analysis - Extend your understanding

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00:00:00 Focus on PharmaSolid Form Analysis: Extend your understanding
00:04:32 Why Solid Form Analysis?
00:05:49 USP<941> guidance for X-ray diffraction
00:06:48 Outline
00:08:01 In situ stability tests
00:08:28 Example 1: α-α-Trehalose
00:09:28 Example 1: α-α-Trehalose
00:11:46 Example 1: α-α-Trehalose
00:12:48 Example 2: Protein in situ humidity studies
00:14:50 Example 2: Hen Egg White Lysozyme (HEWL)
00:16:32 Example 2: HEWL in situ humidity study
00:18:59 High-throughput screening (HTS)
00:19:28 HTS with Empyrean
00:21:31 Data treatment with HighScore Plus
00:23:24 Crystallization plates integration
00:24:54 Example 1: Bovine insulin
00:25:26 Example 2: Anthranilic acid
00:26:49 Amorphous materials: quantification and structure
00:27:15 Quantification – low amorphous content
00:28:19 Quantification from X-ray diffraction data
00:31:18 Partial Least-Squares Regression (PLSR)
00:33:02 Quantification – low amorphous content
00:34:07 Quantification – low amorphous content
00:35:29 How X-ray diffraction sees the world
00:36:01 How X-ray diffraction sees the world
00:36:28 How X-ray diffraction sees the world
00:36:51 Pair-Distribution Function (PDF)
00:38:37 PDF analysis
00:39:24 Industrial interest
00:40:29 Example 1
00:41:19 Example 2
00:42:01 Example 2 – amorphous API
00:42:42 Example 2 – amorphous API
00:43:52 Example 2 – amorphous API
00:44:25 Internal and surface structure of solid dosage forms
00:44:59 Computed Tomography (CT)
00:46:10 API Distribution
00:47:55 QC: Batch comparison
00:49:15 Wall thickness analysis
00:51:31 Summary
00:52:36 Summary
00:53:23 Untitled
00:53:33 Thank you for your attention!

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.


Natalia Dadivanyan Ph.D. - Application Specialist XRD

자세한 내용

  • Who should attend?

- Anyone engaged in developing methods for XRPD 

- Anyone who is developing pharmaceutical formulations 

- Researchers engaged in chemical development or support of scale up activities 

- Anyone engaged in polymorph screening activities as part of lead optimization activities 

- Anyone engaged in producing or setting specifications for pharmaceutical raw materials or intermediates 

  •  Why attend?

- To learn about advanced applications of an XRPD system that are important for pharmaceutical products

- Understand how these methods can be applied within pharmaceutical development