Pressure testing machine IVIVC

air flowflowcomputer-controlled

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.

Key concepts

• Realistic breathing profiles to reproduce patient inhalation behaviour during APSD/DDU testing.
• Realistic throat and nasal models to better reflect in vivo deposition and improve clinical relevance of in vitro measurements.
• Combination of hardware (impactors, flow/pressure control, pumps, induction ports, mixing inlets, mouthpiece/nosepiece adapters) with software analysis to deliver reproducible APSD/DDU data that is more representative of clinical performance.

Products featured in this system

• High Capacity Pump HCP7
• Critical Flow Controller TPK 100i
• Next Generation Impactor (NGI)
• NGI Induction Port
• Mixing Inlet
• Mouthpiece Adapters
• NGI Cooler™
• Compressed Air Flow Controller
• Breathing Simulator BRS 200i
• Inhalytix®+ APSD Data Analysis Software

Related accessories and options

• Alberta Idealised Throat (AIT) and other realistic throat/nasal models
• Air Compressor for Mixing Inlet
• Stand for TPK
• Real-Time Breath Profile Verification Chamber
• Label Printer and other ancillaries for system configuration and data management

Systems and applications

• APSD measurement of nebulisers using clinically relevant setups (throat/nasal models + breathing profiles)
• DDU testing for nebulisers integrated into IVIVC test systems
• Support for comparative/bioequivalence studies, product development and investigations of variability in inhaled drug delivery

Multimedia
The page includes an embedded video demonstrating a system for improved in vitro–in vivo correlations (IVIVCs) of inhaled drug products and multiple illustrative system images showing APSD/TPK/NGI setups and screens.

Technical features / specifications

• Focus: improved clinical relevance of APSD and DDU via realistic breathing profiles and throat/nasal models
• Hardware components listed: pumps (HCP7), flow controllers (TPK series), impactors (NGI), induction ports, mixing inlets, mouthpiece/nosepiece adapters, NGI Cooler™, compressed air controllers
• Breathing simulator: BRS 200i (used to reproduce patient breathing profiles)
• Data analysis: Inhalytix®+ APSD data analysis software for processing APSD/DDU results
• Intended uses: method development, comparative/bioequivalence testing, product characterisation, workflow optimisation and investigating variability in inhaler/nebuliser testing
• System configurability: modular components and accessories to assemble IVIVC test systems tailored to nebuliser APSD and DDU testing