Analytical Technologies Singapore

Copley’s comprehensive range of world leading products for inhaler testing extends to equipment, software and services for every stage of development for both innovator and generic products. 

The devices used for inhaled and nasal drug delivery are collectively referred to as orally inhaled and nasal drug products (OINDPs). Contact us for more information of the products.

The DDU is the total mass of drug emitted from the inhaler and hence available to the patient.Delivered Dose Uniformity (DDU) is measured by firing the test device into a sampling apparatus which contains a filter. The active drug caught on the filter is then dissolved in solvent and analysed using High Pressure Liquid Chromatography (HPLC).

The Aerodynamic Particle Size Distribution (ASPD), along with Delivered dose, is widely recognised as a Critical Quality Attribute in the in vitro characterisation of OINDPs. The ASPD of an aerosol will determine where the particles in that cloud are going to deposit in the body, amongst other information. 

Delivered Dose Uniformity (DDU)

DDU is measured by firing the test device into a sampling apparatus which contains a filter. The active drug caught on the filter is then dissolved in solvent and analysed using High Pressure Liquid Chromatography (HPLC). Depending on the type of OINDP under test, different apparatus set-ups are required.

Aerodynamic Particle Size Distribution (APSD)

Together with the delivered dose, aerodynamic particle size distribution (APSD) is typically identified as a Critical Quality Attribute (CQA) for orally inhaled and nasal drug products (OINDPs) making it a primary focus for in vitro characterisation. 

Automation Inhaler Tester

Providing a board road range of labour-saving devices and systems that automate many routine and tedious testing procedures for both delivered dose uniformity (DDU) testing and aerodynamic particle size distribution (APSD) measurement.

Inhaler Ancillaries

Ancillary products are required in addition to the dose collection device and cascade impactor to make up fully operational systems for determining the Delivered Dose Uniformity (DDU) and Aerodynamic Particle Size Distribution (APSD) of orally inhaled and nasal drug products (OINDPs).

Improving IVIVCs

Making a relatively small investment in systems that enhance the clinical realism of standard pharmacopoeial in-vitro test set-ups for delivered dose uniformity (DDU) testing and aerodynamic particle size distribution (APSD) measurement.

APSD Data Analysis Software

Fully compliant data analysis software offers analysts a flexible and validated solution for the analysis and reporting of the aerodynamic particle size distribution (APSD) drug output from all OINDPs.

Special Inhaler Applications

Offering a range of testing equipment for additional qualification and validation of orally inhaled and nasal drug products (OINDPs), including assessments of generic drug formulations, inhaled dissolution testing and improving IVIVCs.