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 Delivered Dose
    The amount of drug that is supplied from the inhalation system
    (DD DD
    Delivered Dose -The amount of drug that is supplied from the inhalation system
    )
  • Aerosol Aerosol
    An aerosol is a colloid of fine solid particles or liquid droplets, in air or another gas.
    Losses
  • Drug Residue
  • Nebulization Time
  • Mass Median Diameter [µm] (MMD MMD
    Mass median diameter – The mass median diameter (MMAD) is the diameter such that half the aerosol particles is contained in particles with larger diameter and half the particles with smaller diameter, i.e. M normalized (MMD)=1/2.
    )
  • Mass Median Aerodynamic Diameter [µm] (MMAD)
  • Respirable Fraction (RF)
  • Respirable Dose Respirable Dose
    The amount of respirable drug (Particle size < 5 µm) that is supplied from the inhalation system.
    (RD RD
    The amount of respirable drug (Particle size < 5 µm) that is supplied from the inhalation system.
    )
  • Drug Delivery Rate (DDR)
  • Respirable Drug Delivery Rate Respirable Drug Delivery Rate
    The amount of respirable drug that is supplied at the mouthpiece per minute.
    (RDDR RDDR
    The amount of respirable drug that is supplied at the mouthpiece per minute.
    )