Chemical Particle Characterization in Respiratory Drug Products

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.

Foreign Particulate Matter in Inhalables

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.

  • Foreign particle status of formulations, agents and excipients; foreign particle load in administered doses
  • Method development and validation of foreign particle studies
  • Routine foreign particle monitoring and release testing of nasal spray suspensions
  • Testing for particulate matter release on capsules and inhaler parts
  • Quality assurance and foreign particle analytics in inhalable drugs
  • Cleanliness analyses for incoming inspection of inhaler component parts

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.

Dry Powder Inhaler Data

An overview of particles material found from a 15 year investigation on Dry Powder Inhalers in 6 different products.

Main Sources of Foreign Particulate Matter Recovered While Simulating Use fo Three DPIs Foreign Particulate Matter

Particle Composition Source
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.

1. During our studies no significant amount of FPM that might be considered dangerous (such as asbestos) was found.

2.  In some cases we concluded that the contamination profiles in a dry powder inhaler was strongly dependent on sampling point (dose number) in the filetime of the device.

3. In on example, after the first couple of actuations the particles chemical nature changed from larger cellulose particles and fragments, to smaller poymer particles.

4. Polymer particles were typically found to originate frm the device itself.

5. Regardless of device life-stage,the most prevalent contaminants were cellulose, poymers, carbon and proteins.

6.Particles can be generated during device usage.



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