<p>Particle Size Distribution is a very important parameter to be tested before drug product release. A correct particle size distribution ensures the bioavailability of the active drug on the target site of action. An unapproved particle size distribution may lead to waste of drug doses and decreased efficacy of the dose. For example, a very fine particle/droplet distribution of Nasal Spray (<10 micron) will deposit more spray droplets in the lungs and gastrointestinal tract than the nasal passageway which is the target site of action. To ensure maximum deposition of the spray droplets in the nasal passageway the particle size should be more than 10 micron. Therefore, particle size distribution analysis is an obligatory test before product release.</p>
Particle Size Distribution is a very important parameter to be tested before drug product release. A correct particle size distribution ensures the bioavailability of the active drug on the target site of action. An unapproved particle size distribution may lead to waste of drug doses and decreased efficacy of the dose. For example, a very fine particle/droplet distribution of Nasal Spray (<10 micron) will deposit more spray droplets in the lungs and gastrointestinal tract than the nasal passageway which is the target site of action. To ensure maximum deposition of the spray droplets in the nasal passageway the particle size should be more than 10 micron. Therefore, particle size distribution analysis is an obligatory test before product release.
FDA recommends using LASER DIFFRACTION technology for particle sizing of various pharmaceutical products. Our supplied equipments are also built with Laser Diffraction technology and complaint with ISO 13320-1 and CFR 21 rule 11.
BIO-XIN supplies a wide range of particle size analysis equipments for
