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Nasal Spray Test

Application

 Nasal Spray APSD Test

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Description

Features

Specification

Standards

Video

To ensure better deposit of drugs in nasal cavity other than lung, nasal products such as nasal sprays generate particles with aerodynamic diameters mostly between 20-200μm. However, nasal sprays generate some (often <5%) particles <10μm, these tiny particles can penetrate the lower respiratory tract or lung. It is therefore important to quantify this fine particle dose (FPD) generated by nasal sprays. Cascade impactors (NGI, ACI) are used to capture 0-10μm particles. The combination of cascade impactor with nasal spray expansion chamber is used to measure fine particle doses of drugs in nasal sprays and nasal aerosols.

Cascade impingers (NGI, ACI) are designed to capture particles in the 0-10 micron range. Connect the cascade impactor with a nasal spray expansion chamber can be used to measure the fine particle dose in particles or droplets of nasal sprays.

 

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 plume.

FDA Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (2003)

FDA Nasal Spray, Inhalation Solution, Suspension & Spray Drug Products2002

Nasal Preparations (Dosage Forms 0676) Ph.Eur. 2021 10.5

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