DDU of Dry Powder Inhalers (DPIs)
The basic requirements for Dry Powder Inhalers DDU testing are the same as for MDI testing, namely DUSA, mouthpiece adapter, vacuum pump and flow meter. However, a critical flow controller (e.g. Critical Flow Controller TPK 100i) to measure the pressure drop across the device and control the flow conditions during testing is also required. This is because most DPIs are passive breath-actuated devices which rely on the patient’s inspiration rather than a propellant for dose aerosolisation and delivery. The testing of DPIs is further complicated by the fact that different inhalers provide varying degrees of flow resistance, i.e. some require more effort to inhale through than others.
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DDU Over the Entire Contents
In the case of DPI reservoir type devices, tests should be carried out throughout the life of the inhaler i.e. dose uniformity over the entire contents.
Learn MoreInhaler Support Accessory
Designed for larger Dry Powder Inhalers (DPIs) and particularly multi-dose disc-shaped devices, this new fixture provides a stable, airtight seal with an Induction Port or DUSA tube without the need for manual support. Its robust construction and spring-loaded retaining mechanism ensure seamless compatibility with Copley’s Mouthpiece Adapters, enhancing repeatability of DPI testing for generic development and bioequivalence studies.
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We also offer a range of equipment for additional MDI testing application support:
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Two factors have been identified as being critical to improving the clinical relevance of DDU testing and APSD measurement: realistic breathing profiles and realistic throat and nasal models.
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All of the tests involved in Delivered Dose Uniformity require the collection and drug recovery of individual doses into the collection tube of a Dosage Unit Sampling Apparatus (DUSA) appropriate to its type (MDI or DPI) prior to assay.
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