The latest accessory from Copley Scientific, the global leader in inhaled product testing equipment, simplifies the measurement of delivered dose uniformity for nasal drug products in accordance with the recently revised specifications in European Pharmacopoeia (Ph. Eur.)1 Chapter 0676 and US Pharmacopoeia (USP) Chapter <601>2. The new nasal 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 a Vertus II/Plus, Copley’s automated shake and fire system, it supports automated, high productivity, high repeatability testing. Introduction of the new interface means that all routine test set-ups for nasal drug products are now easily automated using Copley’s complete integrated solution.
Dose uniformity is a critical quality attribute for nasal drug products because of its direct impact on clinical efficacy. Dose uniformity measurements involve vertical or near vertical firing of the nasal drug product and capture of the released dose. Leakage and loss of dose, back on to the product nozzle, is a common problem, as is variability arising from manual product actuation.
The Vertus II/Plus is a well-established fully automated shake and fire system for nasal drug product actuation. Automated actuation of the nasal drug product reduces analytical variability, at the same time improving test productivity and reducing health and safety risks for analysts. With the introduction of the new interface, the Vertus II/Plus can now be used with:
- A standard metered dose inhaler DUSA – as specified in recent revisions to the Ph. Eur. and USP, which are more prescriptive than preceding versions with respect to dose capture.
- A Nasal Spray Dose Collector – an accessory designed specifically for nasal drug product testing that combines highly efficient drug capture and ease-of-use.
- A Nasal Spray Waste Collector – for firing to waste under representative conditions.
Together these products represent a complete solution for dose uniformity for nasal drug product dose uniformity testing. Furthermore, the Vertus II/Plus can be interfaced with any routinely used cascade impactor, via an expansion chamber or Alberta Idealised Nasal Inlet, to measure the aerodynamic particle size distribution of the respirable fraction of the dose, to assess the risk of drug delivery via the lungs. Such testing is recommended by the regulators for both new and generic products.
To find out more about Copley’s full range for nasal drug product testing and how it can help with faster, more effective product development go to www.copleyscientific.com.
- Ph. Eur. 10.5 Nasal Preparations, Nasalia. 01/2021:0676.
- USP Chapter <601> ‘Aerosols, Nasal Sprays, Metered Dose Inhalers and Dry Powder Inhalers’