| 00:00:00 | Recent trends of using advanced Instrumentation for characterizing topical sprays, aerosolized powders, and nebulizer drug products in accordance with FDA guidance requirements – A joint webinar by Malvern and Next Breath |
| 00:02:25 | Agenda |
| 00:03:11 | Advantages of Nasal Administration |
| 00:04:30 | Nasal Sprays |
| 00:05:35 | Nasal Aerosols |
| 00:07:34 | Nasal Powders |
| 00:11:30 | ANDA vs NDA and Laser Diffraction |
| 00:14:27 | Automated Actuation Systems |
| 00:15:46 | Selection of Actuation Parameters (Hand Study) |
| 00:17:17 | Actuation Velocity and Droplet Size Distribution |
| 00:17:57 | Droplet/Particle Size Distribution by Laser Diffraction |
| 00:18:24 | Life of a Nasal Spray |
| 00:18:54 | Plume Formation, Stability and Dissipation |
| 00:19:26 | Approach to Method Development |
| 00:19:57 | Next Breath Approach to Method Validation (ICH guidelines) |
| 00:20:28 | Global In Vitro BE Differences (Nasal Sprays) |
| 00:21:20 | Release Tests Regulatory Differences |
| 00:21:50 | Drug Product Development using Malvern Spraytec & Chemical Identification |
| 00:22:45 | How do laser diffraction systems measure particle size distributions? |
| 00:23:29 | Size vs. scattering angle Fraunhofer Theory of Diffraction |
| 00:24:13 | Not only Diffraction, but Refraction and Absorption are taking place (Mie Theory) Typically ignoring these factors results in false fines (<10um) |
| 00:25:46 | Basic Laser Diffraction setup (Spraytec) |
| 00:26:21 | Spraytec Light Scattering Data |
| 00:27:11 | What information does laser diffraction provide? |
| 00:27:53 | And how can it be used? |
| 00:29:08 | Nasal spray atomisation dynamics |
| 00:30:32 | Nasal spray delivered particle size |
| 00:31:29 | Actuation force dependence of particle size |
| 00:32:26 | Actuation velocity dependence of size profiles |
| 00:33:22 | Actuation velocity dependence of size distribution |
| 00:33:44 | Viscosity Modifier Polyvinylpyrrolidone (PVP) concentrations versus water (VP3 pump) |
| 00:35:04 | PVP concentrations vs. water: EquadelTM pump |
| 00:35:41 | Chemical Identification of API, Excipients, and Contaminants in OINDP drug products |
| 00:36:25 | The use of Automated Imaging to Differentiate Excipients vs. API, and identify contaminants |
| 00:36:38 | Drug product image analysis : scattergram |
| 00:37:19 | Drug product image analysis: scattergram |
| 00:37:31 | Morphologically Directed Raman Microscopy |
| 00:37:50 | Drug dose Raman spectrum |
| 00:38:10 | Drug Dose chemical classification |
| 00:38:36 | Size distributions of components |
| 00:39:39 | Conclusions |
| 00:40:20 | Contact Information |
Malvern's Spraytec is a key instrument used at NextBreath to measure OINDP particle size distributions, in adherence with FDA guidances. This webinar reviews how Spraytec is used, and how Next Breath uses the data to meet a sponsor's needs.