Particle size plays a particularly significant role in inhalable drug production because particles from 2-15 µm settle in the alveolus. Therefore, regulatory agencies and manufacturers alike follow strict regulations regarding proper sizing and chemical specific detection of the useful active pharmaceutical ingredient, API particles as well as in the tight control of foreign particles in inhalable and nasal
Particle size plays a particularly significant role in inhalable
Particle size plays a particularly significant role in inhalable spray drugs, OINDP.
Morphologically directed Raman spectroscopy is used to determine the chemically specific particle size distribution, CSPSD. This has an significant impact on bioequivalence and is therefore of use for de-formulation studies of originators products.
Early studies on Dry Powder Inhalers (DPI) showed that more than 95% of all foreign particles are organic (plastic and fibers) by origin and therefore cannot be attributed properly to any substance found through SEM/EDS analysis.
Particle size and shape data directs the Raman spectroscopy and delivers a chemical specific particle size distribution. rap.ID offers the world’s most efficient technical solutions to provide rapid and relevant information about API or contamination particles from 2-10 µm.
rap.ID contract testing services provide API and FPM identification method development and validation within an extremely short timeline. Contact us today to streamline your new drug application, ANDA and NDA regarding FPM assessment.
An overview of particles material found from a 15 year investigation on Dry Powder Inhalers in 6 different products.
|Cellulose||Assebly and transport of devicse components.|
|Polymers||Particles generated during uadr of the device.|
|Carbon||Manufaccturing, accembly and transport of device components.|
|Protein||Manufacturing and assebly. Associated with the lactose carrier.|
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