| 00:00:00 | Welcome |
| 00:03:04 | Application of particle size and shape analysis in Oral Solid Dose product formulation |
| 00:03:55 | Applying QbD to OSD development requires a full understanding of a product and its performance |
| 00:05:23 | Guidance is Available in ICH Q6A Regarding When Particle Size is a Critical Quality Attribute |
| 00:06:54 | Excipient and API size and shape data can aid OSD product and process understanding |
| 00:07:56 | Excipient and API size and shape data can aid OSD product and process understanding |
| 00:08:29 | Laser diffraction calculates particle size distributions by measuring particle light scattering intensity |
| 00:09:40 | Laser diffraction offers many advantages for pharmaceutical particle size measurements |
| 00:11:11 | Case study: using laser diffraction to specify and detect changes in excipient blends |
| 00:12:43 | Case study: using laser diffraction to monitor API particle size distributions during scale-up |
| 00:13:39 | Case study: using laser diffraction to monitor API particle size distributions during scale-up |
| 00:14:35 | Case study: using laser diffraction to monitor API particle size distributions during scale-up |
| 00:15:25 | Morphologically Directed Raman Spectroscopy can provide particle size, shape and chemical ID data |
| 00:16:57 | MDRS measures component specific size and shape distributions in support of formulation studies |
| 00:17:42 | MDRS measures component specific size and shape distributions in support of formulation studies |
| 00:18:15 | MDRS measures component specific size and shape distributions in support of formulation studies |
| 00:18:48 | Case study: correlating dissolution performance with API particle shape for a powder formulation |
| 00:20:37 | Case study: quantifying the proportion of different polymorphs within a blend |
| 00:21:44 | Case study: quantifying the proportion of different polymorphs within a blend |
| 00:22:24 | Case study: understanding changes in API cohesively / flowability |
| 00:23:02 | Case study: understanding changes in API cohesively / flowability |
| 00:23:30 | Case study: understanding changes in API cohesively / flowability |
| 00:24:24 | Case study: understanding the impact of API manufacturing process changes |
| 00:25:29 | Case study: monitoring process induced API changes with blended formulations |
| 00:28:49 | Conclusion and Q&A |
| 00:50:20 | Contact Information |
The development of oral solid dose (OSD) products requires a knowledge of how the physical properties of the excipients and active pharmaceutical ingredients (APIs) present within a formulation affect product performance. This requires access to relevant technologies for measurement properties such as particle size, size distribution and particle shape. In this webinar, we will introduce the workflow for OSD formulation and will explore how Morphologically Directed Raman Spectroscopy and laser diffraction can aid formulation developers in material selection and in understanding the impact of formulation processing operations.