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Inhalation Product Services and Support

PPD® Laboratories offers inhalation services support testing and formulation development and specialized inhalation technologies for pulmonary and nasal products, including:

  • Dry powder inhalers (DPI)
  • Pressurized metered dose inhalers (pMDI)
  • Nebulizers UDV and MDV
  • Aqueous nasal sprays
  • Nasal aerosols
  • Novel drug delivery systems
  • Inhaled biologics

Analytical services offered for inhalation products include:

  • Method development and optimization
  • Method validation, qualification and transfer
  • Stability, release and QC testing
    • Appearance and color testing
    • Dehydrated alcohol content
    • Device counters
    • Dose content uniformity
    • Drug content assay
    • Extractables/leachables
    • Foreign particulate matter
    • Identification
    • Impurities and degradation products
    • Leak rate
    • Microscopic evaluation
    • Net content or fill weight
    • Particle size by laser diffraction
    • Particle-size distribution by inertial impaction
    • Particle size and shape including true shape and image analysis by Clemex PS3
    • Plume geometry
    • Preservatives
    • Pressure
    • Related substances methods
    • Retention of prime
    • Shot weight
    • Spray pattern
    • Spacer testing
    • Stability-indicating assay
    • Total number of actuations
    • Valve delivery
  • Testing performed in tightly controlled humidity rooms
  • Formulation evaluation studies
  • Inhalation formulation development services for pMDI, DPI, nasal and inhalation solutions
  • Drug product characterization studies (device robustness, dosing orientations, effect of resting times and others)
  • Full extractables and leachables program support for container and closure systems utilized in the development of inhalation and medical device products
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