INHALER TESTER
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.
Improving IVIVCs
Making a relatively small investment in systems that enhance the clinical realism of standard pharmacopoeia in-vitro test set-ups for delivered dose uniformity (DDU) testing and aerodynamic particle size distribution (APSD) measurement may help bridge the gap between data collected during QC testing and in vivo performance helping to accelerate and improve R&D.
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Improving IVIVCs
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Delivered Dose Uniformity (DDU)
MDIs
The uniformity of the delivered dose of a drug emitted from a device is a Critical Quality Attribute (CQA) for the determination of safety, quality and efficacy of orally inhaled and nasal drug products (OINDPs).
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). |
*NEW* Inhaler Testing Workstation (ITW)
Mainly used for DDU testing. The ITW keeps the DUSA collection tube, vacuum connection, flow meter and waste shot collector (WSC2) in place during the testing process.
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FEATURES
Stable and secure platform for test components Quick-slide attachments for rapid method change Supplied with quick-release connectors for easy interfacing Suitable for both right- and left-handed configurations Flexible configurations to suit different testing requirements |
Aerodynamic Particle Size Distribution (APSD)
Next Generation Impactor (NGIs)
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. Typically particles should be in the range of 1 to 5 microns to be effective, any larger than 5 microns and they are likely to impact the oropharynx and be swallowed, any smaller than 1 micron and it is possible that the particles will remain entrained in the air system. |
TYPES OF INHALERS FOR DDUs
APSD for Metered Dose Inhalers (MDIs) Next Generation Impactor (NGIs) Anderson Cascade Impactor (ACI) Multi Stage Liquid Impinger (MSLI) Glass Twin Impinger (GTI) APSD for Dry Powder Inhalers (DPIs) APSD for Nebulisers APSDs for Aqueous Droplet Inhalers (ADIs) APSD for other Nasal Products |
Ancillaries
Copley offers a range of ancillary products required in addition to the Dosage Unit Sampling Apparatus (DUSA) 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).
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Related instruments
Pharmaceutical Testers
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Powder Analysers
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*Pictures shown above are for reference only. Actual product may differ slightly.
**Some products may not be available in all countries. Please contact us for further information and clarification. |
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