Nasal inlet port selection:
Aerodynamic particle size analytical technique selection.
Measurements were made using either a short stack ACI or an NGI with <9µm or 10µm being recorded.
A consensus opinion was sought by surveying industry and government agencies.
Samples for testing
Nasal spray samples with ‘low’ and ‘high’ %< 10µm were tested using the different nasal ports
These systems were then tested to see if the method can distinguish between them and thus a scientific and practical approach is proposed.
Two nasal posts were persued – glass & metal. Inter & intra-Lab data will be collected to compare the performance of each method.
Several discussions have been held with the EMA Inhalanda group who are in agreement with the approach and interested to review any proposed methods from EPAG with regard to measuring % < 10µm in nasal sprays thus expert opinion and data have been shared with regulatory agencies.
The information will also be published and also shared with industry at a respiratory seminar in the future.