Assessment of Nasal Products – Proposing a New Inlet
Niklas Baltz and Regina Scherließ
Department of Pharmaceutics and Biopharmaceutics, Kiel University, Grasweg 9a, 24118 Kiel, Germany
With increasing interest in intranasal applications, quality attributes of nasal medicines are gaining more interest. The Ph.Eur. requires nasal products, inter alia, to be tested for uniformity of delivered dose and EMA and FDA furthermore recommend the assessment of the sub 10 micron fraction. Yet, a suitable setup for both applications including an inlet is missing. This study presents considerations regarding the inlet design for the assessment of nasal products and proposes a newly developed inlet for discussion.
A new inlet, the Kiel Nasal Inlet, was developed for the assessment of nasal products, for example with respect to emitted dose and sub 10 micron fraction. The inlet was easy to handle and led to reproducible results. First data are presented to initiate discussion.