Fecha registrada: August 05 2014

Duration: 45 minutes 31 seconds

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.

Table of contents
1. Novel analytical technologies for product de-formulation - Part 1: Nasal spray product development for generic pharmaceutical companies
00:52
2. Novel analytical technologies for product de-formulation - Part 1: Nasal spray product development for generic pharmaceutical companies
01:24
3. Novel analytical technologies for product de-formulation
01:03
4. Nasal pump sprays are widely applied for both local and systemic drug delivery
01:32
5. The filtration and clearance mechanisms within the nose make drug delivery challenging
01:26
6. For nasal sprays, guidance is available regarding bioavailability assessments
00:30
7. The following CQAs are suggested by the FDA when carrying out in vitro BA / BE studies
01:41
8. Laser diffraction droplet size analysis provides a means of assessing atomization performance
02:21
9. Changing the Newtonian viscosity of a formulation has a significant affect on the atomisation dynamics
01:43
10. Using thixotropic formulations may yield improved atomisation at high actuation forces / velocities
01:43
11. Changing the nasal spray pump mechanism may provide a means of improving atomisation
01:14
12. The actuator orifice diameter can also be reduced in order to change the delivered droplet size
01:07
13. Changing the pump and orifice may impact other plume characteristics such as the plume angle
00:51
14. Nasal spray suspensions
01:59
15. Particle differentiation based on shape
00:32
16. Automated Morphological Imaging for API Particle Sizing pre- and post-actuation
00:53
17. Automated Morphological Imaging for API Particle Sizing pre- and post-actuation
00:41
18. When particle differentiation based on shape is not possible
01:11
19. Morphologically Directed Raman Spectroscopy (MDRS) for API Particle Sizing
02:07
20. Compare particle Raman spectra to reference spectra
01:08
21. Differentiate particles based on Chemistry
01:00
22. Relate particle chemistry to particle shape for more efficient particle targeting
01:32
23. Relate particle chemistry to particle shape for more efficient particle targeting
01:04
24. Size Class based on chemically identified API particles
00:38
25. Conclusions
14:05
26. Contact Information
01:14