ASSESSMENT

“I do not need to make my son Dylan take his treatments anymore, he does it by himself. This eFlow Technology device (Trio) is great!”

Dylan’s Mom, Cleveland, Ohio

Analytical Methods:
We have extensive expertise in developing selective analytical methods for quantification of drugs and excipients even in very low concentrations. This is a prerequisite to measuring drugs either dissolved or dispersed in aerosols. PARI methods have been adopted into universal standards (CEN) and are in compliance with a variety of standards, guidances and guidelines, issued by the FDA, EMEA, and CPMP. Our modern analytical equipment includes HPLC combined with UV, photodiode array, evaporative light scattering (ELSD) and mass spectrometry detectors.

Particle Sizing and Breath Simulation:
Particle sizing and breath simulation measurements provide comprehensive information to predict deposition.

PARI has made significant contributions to investigate the effects of test conditions on the particle size distribution patterns. Laser Diffraction (Malvern) and Cascade Impaction (Andersen and NGI) are used to assess the geometric and aerodynamic droplet / particle size distribution patterns of nebulized aerosols for the calculation of parameters. Particle sizing and breath simulation measurements provide comprehensive information to predict deposition. Breath Simulation gives a more realistic model of real life conditions. PARI scientists have developed two proprietary devices to measure aerosols under Breath Simulation: PARI Compass Breath Simulator and Breathing Monitor. The ability to use the results from both particle sizing and breath simulation give a more realistic picture for clinical trials and regulatory submissions. Measurement parameters include:

  • Delivered Dose (DD)
  • Aerosol Losses
  • Drug Residue
  • Nebulization Time
  • Mass Median Diameter [µm] (MMD)
  • Mass Median Aerodynamic Diameter [µm] (MMAD)
  • Respirable Fraction (RF)
  • Respirable Dose (RD)
  • Drug Delivery Rate (DDR)
  • Respirable Drug Delivery Rate (RDDR)