DDU of Nasal Products

Kiel Nasal Inlet

Developed by the Department of Pharmaceutics and Biopharmaceutics at Kiel University, and commercialised in partnership with Copley Scientific, the Kiel Nasal Inlet (KNI) is a robust, precision-engineered dose collection apparatus designed to support reliable Delivered Dose Uniformity (DDU) and Aerodynamic Particle Size Distribution (APSD) testing of nasal drug products.

The KNI enables vertical and near-vertical actuation and provides complete dose capture while minimising splashback, drips, and leakage – ensuring accurate and reproducible results. Its vented design allows it to be used for DDU testing, with or without an applied airflow, as well as in conjunction with an induction port for APSD testing, supporting the evaluation of the mass fraction of particles and droplets <10μm, in line with EMA and FDA guidance.

Compatible with both the Next Generation Impactor (NGI) and the Andersen Cascade Impactor (ACI), and made from the same solvent-resistant materials as Copley Dose Uniformity Sampling Apparatus (DUSA), the KNI is ideal for use in both R&D and QC environments.

• Enables vertical or near-vertical actuation for DDU and APSD tests
• Minimises splashback and leakage to ensure full dose collection
• Vented design ensures a more clinically realistic application when used with an applied air flow
• Supports EMA and FDA guidance for assessing particles/droplets <10μm
• Compatible with NGI and ACI
• Flexible inlet design for use with different device types
• Compatible with Copley DUSA Tube Shaker (DTS 100i)
• Solvent-resistant materials for reliable recovery and easy cleaning
• Precision-engineered and serialised for traceability

To learn more about the development and application of the KNI, click here to read a paper authored by the team at Kiel University:
Advancing nasal formulation characterization: Considerations toward a robust and precise method to determine the mass fraction below 10 μm in nasal products. Aerosol Science and Technology, 58(11), 1305–1317.