| 00:00:00 | Welcome |
| 00:01:30 | The deformulation workflow needs to consider the RLD product API and excipient properties |
| 00:05:48 | The deformulation workflow needs to consider the RLD product API and excipient properties |
| 00:06:29 | Morphological imaging enables particle classification on the basis of the size and shape of particles |
| 00:08:27 | Morphologically-Directed Raman Spectroscopy extends this capability by identifying particles |
| 00:09:17 | The MDRS measurement workflow uses size and shape classifications to target Raman measurements |
| 00:10:07 | The MDRS measurement workflow uses size and shape classifications to target Raman measurements |
| 00:10:49 | The MDRS measurement workflow uses size and shape classifications to target Raman measurements |
| 00:11:44 | The FDA has recently recognized the role MDRS has in supporting in vitro bioequivalence studies |
| 00:13:11 | Case Study: characterization of nasal spray suspension formulations |
| 00:15:36 | Case Study: characterization of nasal spray suspension formulations |
| 00:16:12 | MDRS extends image analysis using Raman spectroscopy to identify different materials |
| 00:17:04 | The analysis speed is optimized by defining a target particle size or shape range for Raman analysis |
| 00:18:14 | Components are identified by spectral matching enabling API-specific data to be generated |
| 00:18:59 | Components are identified by spectral matching enabling API-specific data to be generated |
| 00:19:43 | Case study: measuring the size and shape of two APIs in a dry powder inhaler formulation |
| 00:21:05 | Case study: measuring the size and shape of two APIs in a dry powder inhaler formulation |
| 00:21:52 | Case study: measuring the size and shape of two APIs in a dry powder inhaler formulation |
| 00:22:52 | Case study: measuring the size and shape of two APIs in a dry powder inhaler formulation |
| 00:23:56 | Case study: measuring the size and shape of two APIs in a tablet formulation |
| 00:25:06 | Case study: measuring the size and shape of two APIs in a tablet formulation |
| 00:25:14 | Case study: measuring the size and shape of two APIs in a tablet formulation |
| 00:26:24 | Case study: characterizing complex emulsions and topical formulations |
| 00:26:59 | Case study: characterizing complex emulsions and topical formulations |
| 00:27:48 | Case study: characterizing complex emulsions and topical formulations |
| 00:28:28 | Case study: characterizing complex emulsions and topical formulations |
| 00:29:11 | Case study: quantifying the proportion of different polymorphs within a blend |
| 00:30:17 | Case study: understanding the API manufacturing process for a tablet formulation |
| 00:31:30 | Conclusion |
| 00:32:37 | Thank you for your attentionAny questions?Please type your questions in using the Q&A panel on the right side of your screen |
| 00:33:20 | Thank you |
In a recent newsletter, the US FDA highlighted the important role Morphologically-Directed Raman Spectroscopy (MRDS) can play in supporting the development of generic drug products. The component-specific particle size and shape distribution data generated by this technique can aid sponsors with pinpointing the formulation characteristics and possible manufacturing route used for a Reference Listed Drug (RLD) product, and provides the in vitro data required to support bioequivalence studies. This webinar will consider the workflow associated with RLD deformulation and will introduce the technique of MDRS and its application in developing complex generics including Oral Solid Dose (OSD), Topical and OINDP formulations.