Flow test system MDIs

simulationfor the pharmaceutical industryfor research and development

Overview
Two factors have been identified as being critical to improving the clinical relevance of Delivered Dose Uniformity (DDU) testing and Aerodynamic Particle Size Distribution (APSD) measurement: realistic breathing profiles and realistic throat and nasal models. This page presents IVIVC test systems designed to deliver more clinically relevant DDU and APSD data for MDIs, DPIs and SMIs.

System options

• Realistic DDU — configuration focused on delivered dose uniformity using anatomically relevant mouth/throat or nasal models and realistic breathing profiles.
• Realistic APSD — configuration focused on aerodynamic particle size distribution using throat/nasal models and breathing profiles to improve clinical relevance.

Products featured in this system

• Mouthpiece Adapter — accessory to enable use of inhalers with mouth/throat model interfaces.
• Dose Uniformity Sampling Apparatus (DUSA) — apparatus for sampling delivered dose in DDU studies.
• BRS 300i Breathing Simulator — programmable breathing simulator to reproduce realistic inhalation and exhalation profiles for testing.

Related systems and use cases

• DDU of Dry Powder Inhalers (DPIs) — adapted DDU systems for powder-based devices.
• DDU of Metered-Dose Inhalers (MDIs) — adapted systems for MDIs including sampling and actuator control.
• DDU of Soft Mist Inhalers (SMIs) — systems tailored to aqueous droplet/soft mist devices.

Implementation notes

• The IVIVC test systems combine anatomical throat and nasal models with programmable breathing profiles to replicate patient-like conditions and improve in vitro — in vivo correlation.
• Systems are modular: ancillaries such as breathing simulators, adapters and sampling apparatus (e.g., mouthpiece adapters, DUSA) can be combined to match the device type (MDI, DPI, SMI).
• Multiproduct configurations and tabbed options allow selection between DDU-focused and APSD-focused workflows.

Documentation & supporting materials

• Brochures and system brochures are referenced on the product pages to provide full system descriptions and product specifications.

Caractéristiques / spécifications techniques

• Designed for testing of MDIs, DPIs and SMIs.
• Support for realistic breathing profiles via programmable breathing simulator (e.g., BRS 300i).
• Compatibility with realistic throat and nasal models for improved clinical relevance.
• Modular ancillaries: mouthpiece/nosepiece adapters, Dose Uniformity Sampling Apparatus (DUSA), flow controllers and vacuum pumps as required.
• Intended to produce more clinically relevant DDU and APSD results for method development, product characterisation and comparative/bioequivalence studies.