10 September 2024; Nottingham, UK: A new application note from Copley compares the performance of alternative dose collection solutions for delivered dose uniformity (DDU) testing for solution and suspension nasal sprays and nasal powders. Experimental data highlight the performance of Copley’s Nasal Spray Dose Collector (NSDC) for all product types and provides insight into the complementary utility of alternatives such as the standard dose uniformity sampling apparatus (DUSA) and Kiel Nasal Inlet (KNI). The new note offers valuable information for anyone looking to establish optimised DDU test set-ups for nasal drug products, from R&D through to QC.
The uptick in interest in intranasal drug delivery over recent years has triggered growing scrutiny of the test methods used for product characterisation. Recent gap analysis by the USP Expert Panel on New Advancements in Product Performance Testing (EP-NAPPT)i highlights the scope to improve DDU test set-ups, relative to current compendial specifications, with optimal solutions required for solution, suspension, and powder-based products.
The new application note includes:
- Experimental data demonstrating the performance of the NSDC for two commercial nasal spray suspension formulations.
- Comparative measurements for solution and suspension nasal sprays made with a range of alternative apparatuses: NSDC, KNI, standard compendial DUSA, 1L glass expansion chamber and custom-made set-up consisting of frit and snap-lid jar.
- An assessment of the NSDC, KNI and standard compendial DUSA for nasal powders.
The NSDC was developed specifically for simple and efficient DDU testing for nasal sprays and can be easily integrated within an automated shake, fire and flow control platform for consistent and high throughput analysis. Download the application note to learn more about its potential for optimal nasal drug product DDU testing.
i Sakagami, M. and Fotak, N. Stimuli to the Revision Process ‘Testing the In Vitro Product Performance of Inhalation and Nasal Drug Products: Views of the USP Expert Panel’ Published Sep 2022
About Copley Scientific
Copley Scientific is widely recognised as the world’s leading manufacturer and supplier of inhaled product testing equipment and is a major provider of testing systems for other pharmaceutical dosage forms. The company also supplies equipment for detergent testing.
Copley’s pharmaceutical product range includes testing equipment for all types of orally inhaled and nasal drug products – metered-dose inhalers, dry powder inhalers, nebulisers and nasal products – with a particular focus on solutions for delivered dose uniformity and aerodynamic particle size distribution measurement. It also includes testers for tablets (dissolution, disintegration, friability and hardness) capsules, powders, suppositories, semisolids and transdermals.
Used from R&D through to QC, this extensive range of equipment is supported by a full validation and aftersales service. Copley works in partnership with specialist distributors, extending localised support across the world. This network provides expert help and training to every customer, directly enhancing the application of all Copley products. www.copleyscientific.com
