DDU of Nasal Products
Recent developments in nasal delivery systems has resulted in greater focus on different uses for drug delivery. With great potential for rapid drug absorption into the turbinates and lymphoid tissues located at the back of the nasal cavity, focus has shifted to absorption into the systemic circulation and central nervous system for a wider range of treatments.
Our nasal aerosol testing solutions enable better, more informative testing in line with evolving market requirements.
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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.
KNI Technical Specifications | |
Dimensions (w x d x h): | 178mm x 73mm x 73mm |
System contents: | KNI Collection Tube Filter Support Cap 2x of Rinsing Caps 3x Nosepiece Inlets (5mm, 7.5mm and 10mm) |
Air connector type: | Quick Release |
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DUSA Interface Plate for Nasal Aerosols
Simplifying the measurement of delivered dose uniformity testing for nasal sprays in accordance with the European Pharmacopoeia (Ph. Eur.) Chapter 0676 and United States Pharmacopoeia (USP) Chapter <601>, the nasal dose uniformity sampling apparatus (DUSA) interface plate enables simple, leak-free connection between a standard DUSA and the nasal drug product to ensure complete dose capture. Designed for use with the Vertus® III/III+ automated shake and fire system, routine test set-ups for nasal drug products are now easily automated using our complete integrated solution.
- Apparatus as specified in USP Chapter <601> and Ph.Eur. 0676
- Automated nasal spray shaking (Vertus® III/+)
- Automated nasal spray actuation (Vertus® III/+)
- Automated flow control (Vertus® III/+)
- Automated shot weight measurement (Vertus® III+)
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Nasal Spray Dose Collector (NSDC)
Specially designed for nasal spray DDU testing, the NSDC has an optimised internal geometry to eliminate splashback, drips and leakage following actuation to ensure complete spray dose capture every time.
Designed for use with the Vertus® III/+ automated shake and fire systems, the NSDC enables reproducible and time efficient nasal spray testing. It can also be used as a standalone device for the manual dose collection of nasal sprays.
Nasal Spray Waste Collector (NSWC)
Streamlining nasal spray wasting, the NSWC is designed to collect high volumes of waste aerosol doses with no splashback onto the nozzle for safe and convenient disposal of waste drug product.
Designed for use with the Vertus® III/+ automated shake and fire systems, the NSWC improves the speed and efficiency of nasal spray wasting.
Vertus® III Range – Automated Shake and Fire Systems for MDIs, Nasal Sprays and Nasal Aerosols
Semi-Automation Tools
Improve efficiency
Reduce variability
Eliminate handling errors
Increase testing capacity Semi-Automation Tools
All of the tests involved in Delivered Dose Uniformity require the collection and drug recovery of individual doses into the collection tube of a Dosage Unit Sampling Apparatus (DUSA) appropriate to its type (MDI or DPI) prior to assay.
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