| 00:00:00 | Novel analytical technologies for product de-formulation - Part 1: Nasal spray product development for generic pharmaceutical companies |
| 00:00:52 | Novel analytical technologies for product de-formulation - Part 1: Nasal spray product development for generic pharmaceutical companies |
| 00:02:16 | Novel analytical technologies for product de-formulation |
| 00:03:19 | Nasal pump sprays are widely applied for both local and systemic drug delivery |
| 00:04:51 | The filtration and clearance mechanisms within the nose make drug delivery challenging |
| 00:06:17 | For nasal sprays, guidance is available regarding bioavailability assessments |
| 00:06:47 | The following CQAs are suggested by the FDA when carrying out in vitro BA / BE studies |
| 00:08:28 | Laser diffraction droplet size analysis provides a means of assessing atomization performance |
| 00:10:49 | Changing the Newtonian viscosity of a formulation has a significant affect on the atomisation dynamics |
| 00:12:32 | Using thixotropic formulations may yield improved atomisation at high actuation forces / velocities |
| 00:14:15 | Changing the nasal spray pump mechanism may provide a means of improving atomisation |
| 00:15:29 | The actuator orifice diameter can also be reduced in order to change the delivered droplet size |
| 00:16:36 | Changing the pump and orifice may impact other plume characteristics such as the plume angle |
| 00:17:27 | Nasal spray suspensions |
| 00:19:26 | Particle differentiation based on shape |
| 00:19:58 | Automated Morphological Imaging for API Particle Sizing pre- and post-actuation |
| 00:20:51 | Automated Morphological Imaging for API Particle Sizing pre- and post-actuation |
| 00:21:32 | When particle differentiation based on shape is not possible |
| 00:22:43 | Morphologically Directed Raman Spectroscopy (MDRS) for API Particle Sizing |
| 00:24:50 | Compare particle Raman spectra to reference spectra |
| 00:25:58 | Differentiate particles based on Chemistry |
| 00:26:58 | Relate particle chemistry to particle shape for more efficient particle targeting |
| 00:28:30 | Relate particle chemistry to particle shape for more efficient particle targeting |
| 00:29:34 | Size Class based on chemically identified API particles |
| 00:30:12 | Conclusions |
| 00:44:17 | Contact Information |
Successful development of generic nasal drug products requires sponsors to understand how the dose is atomized by the chosen pump device in order to achieve bioequivalence. In addition, the impact of atomization of the particle size of the drug substance must also be determined in the case of suspension-based products. In this webinar, we introduce how laser diffraction droplet size analysis and Morphologically Directed Raman Spectroscopy (MDRS) can be applied to gain this insight, significantly speeding up the development of new generic formulations.