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.

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 sprays 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 Andersen Cascade Impactor (ACI) and a high volume expansion chamber, such as the Glass Expansion Chamber, the Vertus® II/Vertus® Plus automated shake, fire and flow control systems can be used to meet the need for highly consistent nasal spray actuation as recommended by USP <601>.

Shot weight measurement

The Vertus® Plus model includes an integrated analytical balance for automated nasal spray shot weight measurement.

Nasal Aerosols: Semi-Automated APSD Measurement

The Vertus® automated shake, fire and flow range is made up of integrated turn-key solutions for precise, controlled and reproducible nasal spray testing. Compatible with most nasal sprays, the Vertus II or Vertus Plus 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

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How Does a Cascade Impactor Work?

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Manual Nasal Spray Sampling

In addition to the Vertus® automated shake, fire and weigh systems, we offer a full suite of products to support manual testing, including flow meters, flow controllers and vacuum pumps.

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Semi-Automation Tools

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Reduce variability
Eliminate handling error
Increase testing capacity

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