Novel analytical technologies for product deformulation - Part 1

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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.