Introducing the Copley Inhaled Dissolution Apparatus: a first-of-a-kind commercially available solution for inhaled product dissolution testing.
20 January 2026; Nottingham, UK: The innovative Inhaled Dissolution Apparatus (IDA) from Copley Scientific introduces discriminating dissolution testing to the commercially available in vitro toolkit for inhaled drug products. Addressing a longstanding and evolving industrial need, it brings new insights into in vivo behaviour, enabling faster and more effective development.
The IDA is a complete, integrated solution comprising a dedicated sample collection and transfer system and a purpose-designed dissolution tester. Robust and easy-to-use, it supports confident differentiation of formulation and device performance in early-stage development, while reducing reliance on more complex, expensive and time-consuming in vivo methods. It is suitable for all types of inhaled drug product but will be of particular interest to generic developers working towards regulatory submission in accordance with FDA Product Specific Guidances (PSGs). A growing number of these now specify dissolution for the demonstration of bioequivalence (BE).
“The launch of the IDA breaks new ground in inhaled product testing, reinforcing Copley’s commitment to advancing industry standards,” said Mr Jamie Clayton, CEO. “Its rigorously optimised design reflects our in-depth understanding of emerging challenges in inhaled drug development and builds on our unrivalled record of delivering reliable and relevant testing solutions.  By supporting the development of standardised, easily transferable dissolution test methods, the IDA has the potential to de-risk development and strengthen regulatory submissions – both of which are major gains,”
Despite specific references to dissolution testing in the FDA PSGs there are currently no standardised methods, leaving many researchers little alternative but to develop in-house solutions. Too often the result is sub-optimal, labour-intensive methods that are difficult to validate and transfer, and prone to significant lab-to-lab variability that compromises their value.
The IDA (patent pending) has been specially engineered to integrate sample collection, sample transfer and dissolution testing into a coherent, three-step workflow. Enabling clinically relevant assessment of the respirable fraction of the delivered dose, the IDA:
- Works in combination with established inertial impaction tools to isolate the sub-five micron fraction of the delivered dose.
- Enables undisturbed sample transfer from the dose collector to the dissolution tester using the unique IDA filter holder, maintaining sample integrity and simplifying the workflow.
- Includes a dedicated dissolution tester, the IDA-specific DIS 600i-ID or DIS 800i-ID, building on established, trusted Copley technology.
Suitable for multiple device types, the IDA offers the flexibility to tailor dose collection test conditions such as flow rate and inlet type for compatibility with established methods. The result is data that integrate directly with compendial results to build a more complete picture of in vivo fate and how formulation and device characteristics influence product performance. Early IDA studies, presented at Drug Delivery to the Lung 2025, demonstrate the ability of the apparatus to generate reproducible discriminatory data and its potential value for the nuanced comparison of reference and test products in generic development.
“The IDA offers developers a solution that dovetails with existing workflows to make routine dissolution testing highly accessible.” said Clayton. “Customer response to the IDA has been extremely positive, and we are confident it will deliver real value by supporting stronger in vitro-in vivo relationships and reducing reliance on in vivo studies.”
To find out more about the IDA contact us ([email protected]) or visit our website (www.copleyscientific.com).
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The Copley Inhaled Dissolution Apparatus (IDA), an integrated dose collection and dissolution testing system designed for reproducible inhaled product assessment.
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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
For further information
Press information/Company contact:
Rosanna Kelly, Marketing Manager, Copley Scientific Limited
Colwick Quays Business Park, Road No. 2, Nottingham, NG4 2JY, UK
Tel: +44 (0)115 961 6229
