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Aerodynamic Particle Size Distribution

Aerodynamic Particle Size DistributionWithin each dose of an inhaler device, a consistent distribution of specifically-sized particles is required depending on the condition being treated. Among many other factors, the size distribution of the particles within each inhaler dose, or a dose of any inhaler device, indicates where the drug lands within the respiratory system and how quickly it is dissolved into the user’s system. Typically, the smaller the particle, the further down the respiratory system it travels, and the faster it is absorbed. On the other hand, particles that are too small may be exhaled without impacting at all. Depending on therapeutic intent and desired deposition location in the respiratory tract, the correct aerodynamic particle size plays a big role.

There are several methods to determine Aerodynamic Particle Size Distribution (APSD), such as laser diffraction and time of flight, but the most common industry-accepted practice is using cascade impactors.

Beyond quantifying the overall mass balance of the drug, which requires additional testing such as Deliver Dose Uniformity Testing (DDU), the individual particulate sizing distribution must be within a given tolerance across the lifespan of the inhaler device, from device to device and capsule to capsule.

MSP provides tools to accurately, consistently, robustly, and efficiently gather/collect pharmaceutical aerosols to analyze their chemical characteristics and ensure consistency, from development to quality control (QC).

Accurate – our tools are built above and beyond the high-quality level of tolerance specifications as per the USP. We understand the needs of the industry and supply the system for use in testing and validating.

  • MSP’s Impactors separate the particles into different sizes to be analyzed above and beyond USP guidelines.
  • MSP’s IVIVC (in-vitro in-vivo correlation) reduces development risk and potential time/money spent in preclinical trials.

Robust – using high precision and quality materials, MSP has produced almost 2,000 NGIs to date, most of which are still being used.

Consistent – the high quality manufacturing process and mensuration/calibration services we offer ensures our customers’ tools are still within specifications after sustained use.

Efficient – we design our products specifically for ease-of-use to expedite the drug collection and testing process.

  • MSP’s NGI was designed by the pharmaceutical industry and for the pharmaceutical industry. Using an NGI in liew of legacy cascade impactors makes the testing process more simple – it is easier to use, to clean/maintain, to collect/prepare samples, and incorporates a more ergonomic design.
  • MSP’s NGI Assistant and other basic automation equipment has streamlined the drug recovery process of inhalation testing, improving method transfer and ensuring consistency between drug batches. They eliminate inconsistencies or process variation, and provide reproducible results.