At Drug Delivery to the Lung 2018 (12 – 14th Dec, Edinburgh, UK) Copley Scientific, the global leader in inhaler testing equipment, will release ‘Quality Solutions for Inhaler Testing – 2019 Edition’, the company’s comprehensive brochure that sets products within the context of detailed, practical guidance on all aspects of testing.
Substantially updated with new solutions for both novel and generic product development, the brochure is particularly helpful as the regulatory landscape for the industry undergoes significant change. It is a valuable reference resource for anyone working with orally inhaled and nasal drug products (OINDPs) including: metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulisers and nasal sprays. Drop by the Copley stand to pick up a copy hot off the press!
Products making their debut in the 2019 Edition reflect a dramatic rise in product-specific Food and Drug Administration (FDA) guidance and US pharmacopeia monographs. Accessories for testing Albuterol Inhalation Aerosols, for example, answer directly to specifications in the recently proposed draft product-specific US Pharmacopoeia (USP) monograph.
New inclusions also support industry efforts towards more clinically representative testing and enhanced reproducibility. The new Facemask Test Stand (FMS) and Next Generation Impactor to FMS Interface Accessory, for instance, make it easier to test nebulizers with a facemask in place to obtain more clinically realistic data. Enhanced IVIVC (in vitro in vivo correlation) test systems all feature.
Several core Copley ancillaries have recently been upgraded to deliver enhanced reproducibility via superior automation, state-of-the-art technology, and innovative design.
These include the TPK™ 2100 Critical Flow Controller, a vital accessory for DPI testing, and the BAC™ 2100, an advanced Breath Actuation Controller for automating the flow control associated with testing MDIs.
Incorporating robust, automated data reporting, these next-generation products make testing easier and more productive, while at the same time minimizing the potential impact of user variability.
On display at DDL will be a BAC™ 2100, complete with MDI Actuation Sensor, a discrete device that clips onto the MDI canister to sense manual actuation and enable automatic flow synchronization. Visit the stand to take a closer look at how it enhances MDI testing, to view other products and/or to find out more about any aspect of inhaler testing.