APSD of Nasal Products

Nasal sprays, nasal aerosols and nasal powders typically produce droplets in the range 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. Regulators recommend the use of a cascade impactor in conjunction with a high volume expansion chamber to quantify the amount of drug in the <10 micron range, to assess the potential risk of deposition in the lungs.

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