<p>The devices used for inhaled and nasal drug delivery are collectively referred as Orally Inhaled and Nasal Drug Products, OINDPs. The OINDPs comprises Inhalers (metered dose, dry powder and aqueous droplet), Nebulizers (jet, ultrasonic and vibrating mesh) and Nasal (aqueous based, dry powder and propellant based).</p>
It is widely recognized that Aerodynamic Particle Size Distribution (APSD) is a Critical Quality Attribute in the in vitro characterization of OINDPs. To be therapeutically effective the particle size of OINDPs should be in a particular size range. For example, MDI and DPI particle size should be in the range of 1-5 micron. Particles greater than 5 micron will generally go to the gastrointestinal tract and particles smaller than 1 micron will come out with exhalation. Particles between 1-5 micron have greater chance to be deposited in the lungs which is the target site of deposition.
Cascade Impaction is the sampling procedure for APSD analysis. Cascade Impactors collect particles of different sizes from an inhaler/spray/nebulizer. For Example, the particles of different sizes may range in 0.4-0.7 micron, 0.7-1.1 micron and 1.1-2.1 micron and so on. There are different cups in the cascade impactors to collect particles of different size ranges. The collected particles of different size ranges in different cups are then sent to analyze the Active Pharmaceutical Ingredient (API) by drug assay procedure. Thus, which size of particles carry more drugs can be identified. In more simple word, APSD is like distributing the drug particles into different cups according to their size. Then the drug particles of each cup are chemically measured to identify the delivered drug content.
BIO-XIN provides the world renowned Andersen Cascade Impactor (ACI) and high precision Next Generation Impactor (NGI) for APSD analysis. We also have a support for its service and spare parts for life time.