Copley Scientific, which introduced its new dissolution testing apparatus for OINDPs at DDL 2025, has announced the official launch of the Inhaled Dissolution Apparatus (IDA). The company points out that many developers of generic inhaled drugs have had to resort to assembling and trying to validate their own dissolution testing systems in order to generate data in response to recent FDA guidelines for demonstrating bioequivalence.
The announcement describes the IDA as “a complete, integrated solution comprising a dedicated sample collection and transfer system and a purpose-designed dissolution tester.” The company notes that the IDA uses standard cascade impaction technology and a special filter holder to collect and transfer a respirable dose sample for testing in the dissolution tester and adds that factors such as flow rate and inlet type can varied as needed.
Copley CEO Jamie Clayton commented, “The launch of the IDA breaks new ground in inhaled product testing, reinforcing Copley’s commitment to advancing industry standards. Its rigorously optimized design reflects our in-depth understanding of emerging challenges in inhaled drug development and builds on our unrivaled record of delivering reliable and relevant testing solutions. By supporting the development of standardized, easily transferable dissolution test methods, the IDA has the potential to de-risk development and strengthen regulatory submissions, both of which are major gains,”
Clayton added, “The IDA offers developers a solution that dovetails with existing workflows to make routine dissolution testing highly accessible. 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.”
In 2025, Copley launched a number of new products, including a new Inhalytix+ cascade impactor software package and several pieces of equipment for powder testing.
Read the Copley Scientific press release
