Experts in Nasal Spray, Nasal Aerosol and Nasal Powder Testing Nasal drug product development is currently the focus of considerable research activity. Traditionally, nasal preparations have been used for the local administration of antihistamines, decongestants and steroids in order to alleviate cold or allergy symptoms and nasal congestion. A growing interest in nasal drug product development is largely fuelled by its wide-ranging potential for systemic and nose-to-brain drug delivery, vaccination, and drug repurposing. When it comes to testing these medicines, multiple in vitro techniques can be usefully deployed for either new or generic product development. However, there is a growing need for better strategies to improve the sensitivity and clinical relevance of in vitro nasal drug product test methods to provide more insight for targeted systemic drug delivery and to demonstrate bioequivalence more rigorously. Our nasal drug product testing solutions enable better, more informative testing in line with evolving market requirements. Dose Uniformity Sampling Apparatus (DUSA) For vertical (or near-vertical) nasal product actuation as recommended in Ph. Eur. 0676 and USP <601> Delivered Dose Uniformity (DDU) DDU testing is used to confirm that a consistent dose is delivered throughout the lifetime of the nasal drug product device. We offer two dose collection devices, depending on testing requirements. Nasal Spray Dose Collector (NSDC) Patent Pending An optimised internal geometry eliminates splashback, drips and leakage and ensures complete dose capture every time, while the low internal volume and easy internal access aids drug recovery.

Aerodynamic Particle Size Distribution (APSD) Nasal drug products typically generate particles with an MMAD >10-20µm to ensure nasal deposition and minimise deposition in the lungs. However, they will also produce a proportion of drug in smaller particles/droplets (<10µm) which must be quantified as deposition of this respirable fraction beyond the nasal tract may be undesirable. Aerodynamic particle sizing using a cascade impactor is a US FDA requirement and is recommended in USP <601> to complement other sizing techniques. Glass Expansion Chamber Used together with a cascade impactor (shown...

Automated shot weight measurement via an integrated balance Vertus® III+ with DUSA Interface Plate Automated Nasal Spray Testing Automation not only eases the burden associated with routine analysis, but it also plays an important role in reducing variability and improving data integrity. Our well-established, fully automated and flexible Vertus® shake, fire and flow control systems can be used for nasal spray testing to meet the need for highly consistent actuation, as required by USP <601>. The Vertus® Plus model also includes an integrated analytical balance for automated shot weight measurement....

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