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Nebulizers : Achieving bioequivalence using laser diffraction and automated microscopy

Date recorded: January 31 2017

Duration: 23 minutes 21 seconds

This webinar will center on the use of laser diffraction as a technique in characterizing nebulizers, and how it is helpful in understanding the delivery of the drug product. The presentation will also cover the application of automated imaging technology in achieving OINDP bioequivalence and how this technique is complementary to laser diffraction. Finally there will be a case study which highlights the use of these two technologies in characterizing “Pulmicort respules” as a nebulizer formulation.
Table of contents
1. Welcome
00:13
2. Introduction
01:02
3. Nebulizers – Achieving bioequivalence using laser diffraction and automated imaging
00:08
4. Agenda
00:37
5. A Moment of Truth…
00:26
6. Laser diffraction measures droplet and particle size distributions using light scattering
00:45
7. Dependence of light scattering on particle size
00:42
8. Spray characterisation: why use laser diffraction?
00:05
9. Laser diffraction is applied to understanding the delivery of the drug product
01:05
10. Morphological imaging techniques are now widely applied in OINDP bioequivalence testing
00:38
11. Morphological imaging enables particle classification on the basis of the size and shape of particles
00:30
12. Convexity-State of Dispersion
00:36
13. The data obtained by imaging can be used to understand the state of dispersion of samples
00:05
14. The workflow can be extended to enable component specific measurements if required
00:55
15. Case study
00:04
16. Pulmicort Respules: drug product specific guidance
00:35
17. Pulmicort Respules: in vitro bioequivalence tests
00:21
18. Laser diffraction measurements can be made either using an open measurement zone or a flow cell
00:14
19. For open bench measurements, the position of the nebuliser and extraction unit must be considered
00:44
20. Influence of receiver distance on the measured nebulizer droplet size
01:03
21. Influence of nebulizer distance on the measured droplet size
00:43
22. Influence of extraction distance on the measured nebulizer droplet size
00:32
23. Influence of extraction flow rate on the measured nebulizer droplet size
00:05
24. Droplet size measurement RSD recorded for each method parameter
00:48
25. Open bench method recommendations
00:41
26. Laser diffraction: flow cell measurements
00:57
27. Comparison between laser diffraction and cascade impaction for nebuliser measurements
00:43
28. Flow cell measurements: affect of breathing rate on breath-assisted nebuliser operation
00:57
29. Drug and agglomerate particle size analysis using morphological imaging
00:57
30. Innovator formulation: CE Diameter distributions
00:25
31. Generic formulation: CE Diameter distributions
00:34
32. Innovator & Generic: CE Diameter
00:51
33. Conclusions
00:39
34. Thank you for your attentionAny questions?
03:22
35. Contact Information
00:19
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