| 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.
発表者
Natalia Dadivanyan Ph.D. - Application Specialist XRD
詳細
- 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