Nebulizers : Achieving bioequivalence using laser diffraction and automated microscopy | Malvern Panalytical

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

Contact sales Register now