Recent trends of using advanced Instrumentation for characterizing topical sprays, aerosolized powders, and nebulizer drug products.

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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.