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.

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