APSD of Nasal Products
Nasal drug products typically produce droplets larger than 10-20 microns, to ensure nasal deposition and minimise deposition within the lungs. However, a proportion of fine droplets in the <10 micron range may also be produced. Deposition of this respirable fraction beyond the nasal tract may be undesirable and must be quantified. Aerodynamic particle sizing with a cascade impactor is a US FDA requirement and is recommended in USP <601> to assess potential deposition beyond the nasal cavity.
Our nasal product testing solutions enable better, more informative testing in line with evolving market requirements.
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Like nasal sprays, nasal aerosols also typically produce droplets in the range 20-200 microns, which is outside the effective range of cascade impactors. However, most aerosols typically deliver a proportion (typically <5%) of fine droplets in the <10 micron range, which must be quantified.
Used together with a cascade impactor such as the Next Generation Impactor (NGI) and a high volume expansion chamber, such as the Glass Expansion Chamber, the Vertus® III/Vertus® III+ automated shake, fire and flow control systems can be used to meet the need for highly consistent nasal aerosol actuation as recommended by USP <601>.
Shot weight measurement
The Vertus® III+ model includes an integrated analytical balance for automated nasal aerosol shot weight measurement.
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Nasal Aerosols: Semi-Automated APSD Measurement
The Vertus® III automated shake, fire and flow range is made up of integrated turn-key solutions for precise, controlled and reproducible nasal aerosol testing. Compatible with most nasal aerosols, the Vertus III or Vertus III+ offers analysts complete control over:
- The speed, angle and duration of shaking, ahead of actuation
- Firing force and the speed of application and release of that force
- The time delay between the end of shaking and device actuation
How Does a Cascade Impactor Work?
Manual Nasal Aerosol Sampling
In addition to the Vertus® automated shake, fire and flow systems, we offer a full suite of products to support manual testing, including flow meters, flow controllers and vacuum pumps.
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We also offer a range of equipment for additional nasal aerosol testing application support:
Related Applications
Two factors have been identified as being critical to improving the clinical relevance of DDU testing and APSD measurement: realistic breathing profiles and realistic throat and nasal models.
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Semi-Automation Tools
Improve efficiency
Reduce variability
Eliminate handling error
Increase testing capacity Semi-Automation Tools
Copley supplies a broad range of labour-saving devices and semi-automated systems for Aerodynamic Particle Size Distribution applications.
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Semi-Automation Tools
Copley supplies a broad range of labour-saving devices and semi-automated systems for Aerodynamic Particle Size Distribution applications.
View Product Range
Semi-Automation Tools
Copley supplies a broad range of labour-saving devices and semi-automated systems for Aerodynamic Particle Size Distribution applications.
View Product Range
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