Copley Scientific introduces a simple device for inhaled dose dissolution testing
10th February 2020, Nottingham, UK: The new Inhaled Dissolution Dose Collector (IDDC) from
Copley Scientific is a flexible, easy-to-use system for collecting the respirable fraction of the dose
delivered by a metered dose or dry powder inhaler (MDI or DPI) for dissolution testing. The
dissolution profile of inhaled drugs underpins therapeutic efficacy and is an area of increasing
regulatory scrutiny, particularly for the demonstration of bioequivalence in a generic. The new
IDDC works efficiently with standard inhaler test equipment to reproducibly capture a
representative sample for dissolution testing by US Pharmacopoeia (USP) Method 2, an apparatus
routinely used for tablets.
Following deposition, inhaled drug particles must dissolve and permeate into the lung tissue to
reach their site of action. Dissolution testing elucidates this behaviour and is particularly
important for modified release or low solubility compounds, or when establishing parity between
a test (generic) and reference (innovator) product. Currently published dissolution methods offer
limited flexibility with respect to the particle size ranges analysed, tend to suffer from poor
reproducibility and have low discriminating power. Inconsistent sample collection is a common
The new IDDC accommodates a range of inlet components routinely used to measure the
aerodynamic particle size distribution (APSD) of OIPs by cascade impaction including the standard
USP induction port, the Next Generation Impactor pre-separator, the Fast Screening Impactor
housing/insert and the Albert Idealised Throat. Choice of inlet component determines the particle
size range captured for dissolution testing. This can be the Impactor Sized Mass (ISM - the mass
that would penetrate the first stage of the impactor), the ex-throat dose or the Fine Particle Dose
(FPD); the fraction of the dose defined as respirable on the basis of size. The dose is collected on
a detachable insert, positioned inside a removable filter holder, at a test flow rate in the range 30
to 100 L/min, depending on the MDI or DPI under test. This insert can be directly transferred to a
USP Method 2 apparatus for dissolution testing, similar to the established Paddle over Disc
method (USP Method 5).
Because particles collect evenly across the surface of the IDDC insert, dissolution results are
reproducible and independent of loading. Once a test is complete the insert is simply replaced for
the next test. All wetted parts are manufactured from stainless steel ensuring durable
compatibility with the widest range of dissolution media/simulated lung fluids. Without an inlet
component fitted the unit has a diameter of 200mm and a height of 270 mm, occupying minimal
lab space. In combination these features make the IDDC a practical and efficient tool for those
looking to apply dissolution testing in the development of new and generic OIPs.
To find out more contact: firstname.lastname@example.org
About Copley Scientific
Copley Scientific is widely recognised as the world’s leading manufacturer and supplier of inhaler test 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 test equipment for all types of orally inhaled and nasal drug products - metered-dose inhalers, dry powder inhalers, nebulisers and nasal sprays - 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 has offices in the UK and Switzerland and works in partnership with aerosol particle science experts MSP Corporation in North America; specialist distributors extend 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
- Copley Scientific
- Copley Scientific