The global leader in equipment for inhaled product testing
Copley Scientific is the world’s leading manufacturer and supplier of inhaler test equipment with a comprehensive range of products for testing:
• Metered dose inhalers (MDI), dry powder inhalers (DPI), nebulisers and nasal sprays
• Both innovator (novel) and generic drug products
• In accordance with the USP/Ph.Eur./FDA/EMA requirements
• To secure better in vitro in vivo relationships
• Productively within a high-throughput environment.
Trusted equipment for routine testing
Copley Scientific equipment and accessories are the mainstay of the majority of inhaled product testing facilities. Robust, well-engineered solutions that fully meet the pharmacopoeia specifications for Delivered Dose Uniformity (DDU) and Aerodynamic Particle Size Distribution (APSD) include:
• Dose uniformity sampling apparatus (DUSA) for DPIs, MDIs and nebulisers
• Next Generation Impactor (NGI), Andersen Cascade Impactor (ACI), Multi-Stage Liquid Impinger (MSLI) and Glass Twin Impinger (GTI)
• All the accessories required to efficiently implement a standard inhaler testing set-up where required: mouthpiece adapters, critical flow controller, vacuum pump, breath simulator, flow meter, tubing, connectors and validation tools
• Drug monograph specific equipment for testing Fluticasone Propionate/+ Salmeterol.
Copley inhaler testing data analysis software (CITDAS) is fully validated and efficiently handles all the data generated during cascade impactor measurements, presenting particle size metrics in accordance with pharmacopoeial and regulatory requirements.
Innovative tools for better IVIVRs
Working closely with industry experts and academics, Copley Scientific has an established track record of successful innovation to meet evolving testing needs.
Better in vitro in vivo relationships (IVIVRs) have the potential to accelerate time to market for drug development. They also underpin the secure demonstration of bioequivalence – a critical step in the development of generic OIPs – and help reduce the risk of unexpected outcomes in clinical trials. The set-up shown opposite uses new components alongside established equipment to deliver data that represent in-vivo behaviour more accurately than data from the standard test methodologies originally designed for QC. It includes a(n):
• Alberta Idealised Throat (child and adult) for realistic representation of the human mouth/throat geometry
• Breath simulator for assessing how different patient representative flow profiles impact on drug delivery performance
• Mixing inlet to decouple the variable flow rate through the inhaler from the constant sampling flow rate, when using a cascade impactor.
• Equipment for measuring drug dissolution rates specific to size fractions within the inhalable aerodynamic particle size range.
Accessories for enhancing productivity
Inhaler testing is widely recognised as a labour intensive process. Copley Scientific supplies a broad range of labour saving devices and semi-automated systems for both the ACI and NGI that can free up analyst time for more added-value tasks. By reducing manual input, these tools also help to eliminate the risk of repetitive strain injury (RSI), while at the same time enhancing reproducibility. This part of the range extends from simple rinsing tools for discrete tasks to fully automated, integrated systems for the entire sample recovery process. Furthermore, Copley Scientific also supplies a range of abbreviated impactors, which, when combined with Efficient Data Analysis (EDA) techniques, can also be used to enhance productivity and accelerate product screening.
The reassurance of exemplary lifetime support
Copley Scientific is a company with a focus on quality and a reputation for delivering valued, cost-efficient testing solutions to the pharmaceutical industry that extends over many decades. Covering the complete inhaler testing range is a guarantee of exemplary service and support that extends to:
• Highly informative brochures, user manuals and articles that explain how to use equipment to achieve successful testing within the regulatory framework
• A comprehensive range of fully customised in-house and on-site service contracts to provide quality maintenance and calibration at a competitive price
• In–depth technical and application training from globally recognised experts
• Qualification tools and a complete, quick turn-around stage mensuration service to maintain validated impactor performance.
Read white papers
Refining Inhaled Product Testing: A Review
Understanding the links between drug delivery route and in vitro test methods
Using Breathing Simulators to Enhance Inhaled Product Testing
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