| 00:00:00 | Welcome |
| 00:00:13 | Introduction |
| 00:01:15 | Nebulizers – Achieving bioequivalence using laser diffraction and automated imaging |
| 00:01:23 | Agenda |
| 00:02:00 | A Moment of Truth… |
| 00:02:26 | Laser diffraction measures droplet and particle size distributions using light scattering |
| 00:03:11 | Dependence of light scattering on particle size |
| 00:03:53 | Spray characterisation: why use laser diffraction? |
| 00:03:58 | Laser diffraction is applied to understanding the delivery of the drug product |
| 00:05:03 | Morphological imaging techniques are now widely applied in OINDP bioequivalence testing |
| 00:05:41 | Morphological imaging enables particle classification on the basis of the size and shape of particles |
| 00:06:11 | Convexity-State of Dispersion |
| 00:06:47 | The data obtained by imaging can be used to understand the state of dispersion of samples |
| 00:06:52 | The workflow can be extended to enable component specific measurements if required |
| 00:07:47 | Case study |
| 00:07:51 | Pulmicort Respules: drug product specific guidance |
| 00:08:26 | Pulmicort Respules: in vitro bioequivalence tests |
| 00:08:47 | Laser diffraction measurements can be made either using an open measurement zone or a flow cell |
| 00:09:01 | For open bench measurements, the position of the nebuliser and extraction unit must be considered |
| 00:09:45 | Influence of receiver distance on the measured nebulizer droplet size |
| 00:10:48 | Influence of nebulizer distance on the measured droplet size |
| 00:11:31 | Influence of extraction distance on the measured nebulizer droplet size |
| 00:12:03 | Influence of extraction flow rate on the measured nebulizer droplet size |
| 00:12:08 | Droplet size measurement RSD recorded for each method parameter |
| 00:12:56 | Open bench method recommendations |
| 00:13:37 | Laser diffraction: flow cell measurements |
| 00:14:34 | Comparison between laser diffraction and cascade impaction for nebuliser measurements |
| 00:15:17 | Flow cell measurements: affect of breathing rate on breath-assisted nebuliser operation |
| 00:16:14 | Drug and agglomerate particle size analysis using morphological imaging |
| 00:17:11 | Innovator formulation: CE Diameter distributions |
| 00:17:36 | Generic formulation: CE Diameter distributions |
| 00:18:10 | Innovator & Generic: CE Diameter |
| 00:19:01 | Conclusions |
| 00:19:40 | Thank you for your attentionAny questions? |
| 00:23:02 | Contact Information |
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.