What is Aerodynamic Particle Size Distribution?

Aerodynamic Particle Size Distribution, or APSD, is the distribution of aerosolised particles from an inhaler or nasal drug product according to their aerodynamic diameter. Aerodynamic diameter reflects how particles behave in a moving air stream, which influences where they are likely to deposit in the respiratory tract. In inhaler testing, APSD helps laboratories understand the aerodynamic size of emitted particles and how much of the dose may be capable of reaching different areas of the respiratory tract.

APSD of Metered Dose Inhalers (MDIs)
The APSD testing of MDIs is typically performed at a flow rate of 28.3 L/min when using an ACI or 30 L/min when using an NGI. For Breath Actuated MDIs (BAIs) a Breath Actuation Controller may also be used to generate a time delay. However, it must be noted that when add-on devices such as spacers or valved holding chambers (VHCs) are used, the APSD characteristics may be substantially altered from what is emitted when the MDI is used alone and must be assessed appropriately.
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APSD of Dry Powder Inhalers (DPIs)
The APSD measurement of DPIs is typically performed under the same conditions as DDU testing, however a Preseparator is typically interposed between the induction port and stage 0 of cascade impactor to capture the large, non-inhalable carrier particles, to prevent impactor over-loading. As for delivered dose testing of DPIs, test flow rate is set on the basis of a 4 kPa pressure drop across the device, to approximate the mean patient inhalation flow rate achieved during clinical use.
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APSD of Nebulisers
For devices such as nebulisers, the evaporation of droplets exacerbated by the thermal mass of the impactor can be a problem, especially for drugs in solution. Loss of solvent reduces droplet size, producing artificially low APSD measurements, compromising the integrity of the resulting data. Cooling the impactor to approximately 5°C is the recommended method for overcoming this problem.
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APSD of Soft Mist Inhalers (SMIs)
For ADIs as for nebulisers, the evaporation of droplets exacerbated by the thermal mass of the impactor can be a problem. Loss of solvent reduces droplet size, producing artificially low APSD measurements, compromising the integrity of the resulting data. Cooling the impactor to approximately 5°C is the recommended method for overcoming this problem.
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APSD of Nasal Products
Nasal sprays, nasal aerosols and nasal powders typically produce droplets in the range of 20-200 microns, which is outside the effective range of cascade impactors. However, each may deliver a proportion of fine droplets in the <10 micron range. It is important to quantify this FPD since it can penetrate beyond the nasal tract and into the lower respiratory tract or lungs, which may be undesirable.
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Aerodynamic Particle Size Distribution FAQs

What is Aerodynamic Particle Size Distribution?

Aerodynamic Particle Size Distribution, or APSD, measures the distribution of aerosolised particles according to their aerodynamic diameter. Aerodynamic diameter reflects how particles behave in a moving air stream, taking into account factors such as particle size, density and shape. In inhaler testing, APSD helps laboratories assess where particles emitted from an inhaler or nasal drug product are likely to deposit in the respiratory tract.

What does APSD stand for?

APSD stands for Aerodynamic Particle Size Distribution. It is commonly used in orally inhaled and nasal drug product testing to assess the aerodynamic size of particles or droplets emitted from a device.

Why is aerodynamic particle size important?

Aerodynamic particle size is important because it helps determine whether a product delivers the dose to the intended region of the respiratory tract. Particles that are too large may deposit in the mouth, throat or nasal passages, while smaller particles may travel further into the lungs. Understanding and controlling aerodynamic particle size therefore supports targeted drug delivery, product performance, patient safety and therapeutic efficacy.

What is aerodynamic particle diameter?

Aerodynamic particle diameter describes how a particle behaves in a moving airstream, rather than only its geometric or physical size. It takes into account factors such as particle size, shape and density and inertia, all of which can affect how easily a particle is carried in the air or deposits on a surface. As a result, particles with the same geometric size may not have the same aerodynamic diameter, making this measure especially important when assessing inhaled aerosols and likely respiratory deposition.

What is fine particle dose?

Fine Particle Dose, or FPD, is the mass of drug contained in the fine particle size range, commonly defined as particles below 5 µm aerodynamic diameter. For APSD assessments, it is used to help assess the portion of the emitted dose that may be capable of reaching the lower respiratory tract.

How is APSD measured?

APSD is typically measured using cascade impactors or impingers, which separate aerosolised particles into different size fractions as the aerosol passes through a series of stages. In a cascade impactor, precision nozzles subject the particles to progressively increasing air velocities, causing particles with different aerodynamic diameters to deposit on different stages. The collected drug is then recovered and analysed to determine the aerodynamic particle size distribution of the emitted dose.

Under controlled test conditions. The collected drug is then analysed to determine the aerodynamic particle size distribution of the emitted dose.

Which products require APSD measurement?

APSD measurement is relevant to all orally inhaled and nasal drug products, including metered dose inhalers, dry powder inhalers, nebulisers, soft mist inhalers, nasal sprays, nasal aerosols and nasal powders.

What equipment is used for APSD measurement?

APSD measurement requires equipment such as a Next Generation Impactor, Andersen Cascade Impactor, Multi-Stage Liquid Impinger, flow controllers, preseparators, induction ports and product-specific accessories. The correct set-up depends on the device type and test method.

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