Particle size plays a particularly significant role in inhalable drug production, due to particles from 2-15 µm settling 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 inhalable.
Particle size plays a particularly compelling role in inhalable spray drugs - OINDP.
Morphologically directed Raman spectroscopy is used to determine the chemically specific particle size distribution (CSPSD). This has an important impact on bioequivalence, and is consequently used for de-formulation studies of originator 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 correctly 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 in regards of the API, or contamination particles from 2-10 µm.
rap.ID’s 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 particle materials found during a 15 year investigation on Dry Powder Inhalers in 6 different products.
|Cellulose||Assembly and transport of device components|
|Polymers||Particles generated during of the device.|
|Carbon||Manufacturing, assembly and transport of device components|
|Protein||Manufacturing and assembly, associated with the lactose carrier.|
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