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.
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.