Nasal Group

Objective

To develop EP methodology for Nasal sprays for aerodynamic particle size analysis of two fractions (<10µm & >10µm) thus proposing a standardized approach to measuring this parameter.

Work plan

1st Work-Phase: Selection of “Nasal inlet port” and analytical technique for % <10µm – completed

Nasal inlet port selection:

Metal ports (supplied by 3M &Copley)
Glass flask port
Nasal Cast (supplied by BI)

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.

2nd Work-Phase: Assessing the selected techniques – completed

Samples for testing

Nasal spray samples with ‘low’ and ‘high’ %< 10µm were tested using the different nasal ports

‘low’ fines samples, commercial nasal spray pumps
‘high’ fines samples, prototype nasal MDI samples

These systems were then tested to see if the method can distinguish between them and thus a scientific and practical approach is proposed.

3rd Work-Phase: Method validation package – ongoing

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.

Contact

European Pharmaceutical
Aerosol Group

EPAG, Unit Q, Troon Way
Business Centre, Humberstone Lane,
Thurmaston, Leicester,
LE4 9HA, United Kingdom