Copley Scientific Introduces Simple Device for Inhaled Dose Dissolution Testing

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 analyzed, tend to suffer from poor reproducibility and have low discriminating power. Inconsistent sample collection is a common problem.

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 Idealized 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 200 mm 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.

Copley Scientific is widely recognized 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 localized support across the world. This network provides expert help and training to every customer, directly enhancing the application of all Copley products. For more information, visit www.copleyscientific.com.