Complementary particle characterization techniques for faster DPI development

Summary

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Number of actuations/measurement

Speed of measurement

Metric measured




Regulatory requirement


Primary applications

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Cascade Impaction

Multiple and variable

2 PSD measurements/hour

Aerodynamic particle size distribution of the API



For all OINDPs


Drug delivery efficiency assessment as part of R&D and for routine QC

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Laser diffraction

One

10,000 measurements/sec

Volumetric based particle size distribution and concentration for the formulation

For nasal sprays and some nebulized formulations

Understand and aerosolization behavior during R&D, Routine QC for nasal sprays and some nebulisers

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Further reading on the application of laser diffraction in DPI studies:
P.Kippax and D. Morton “Unlocking the secrets of the dry powder inhaler plume” Drug Delivery Technology, Jan 2008, Vol 8, No1

S. R. R. Behara et al. ‘An approach to characterising the cohesive behaviour of powders using a flow titration aerosolisation based methodology’ Chemical Engineering Science 04/2011; 66(8):1640-1648.

For further reading on the application of MDRS in DPI studies:

Component specific particle characterisation of dry powder inhaler formulations

Extrinsic lactose fines improve dry powder inhaler formulation performance of a cohesive batch of budesonide via agglomerate formation and consequential co-deposition.