Nasal Spray FPD Tests
To ensure better drug deposition in nasal cavity rather than lung, nasal products such as nasal sprays generate particles with aerodynamic diameters mostly among 20-200μm. However, there will be 5% (or less) particles with aerodynamic diameters under 10μm generated, and deposited in the lower respiratory tract and lung. It is therefore important to quantify fine particle dose (FPD) generated by nasal sprays.
Cascade impactors are used to capture 0-10μm particles. The combination of cascade impactor with nasal spray expansion chamber is used to measure fine particle dose of drugs in nasal sprays and nasal aerosols.
1L capacity: used in nasal aerosols to maximize deposition below the top stage.
2L capacity: used in nasal sprays to maximize nebulization and deposition.
5L capacity: for some stronger nasal sprays, additional room is required to be able to generate aerosol plume.
FDA Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (2003)
FDA Nasal Spray, Inhalation Solution, Suspension & Spray Drug Products(2002)
Nasal Preparations (Dosage Forms 0676) Ph.Eur. 2021 10.5