Inhalation Services

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

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

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
• 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

Specialized Inhalation Testing Apparatuses

• Next generation impactor
• Andersen cascade impactors
• Marple-Miller Impactor™M150
• Multistage liquid impinger (MSLI)
• Malvern Spraytec droplet-size analyzer
• HIAC Royco particulate matter analyzer
• Horiba particle-size analyzer
• Clemex PS3 particle sizing system
• TSI digital flow meters
• Copley Scientific
• • Inhaler testing data analysis software (CITDAS)
  • Model TPK critical-flow controller
• Innova Systems
• • Nasal dose weight collection station (NSP-DWCS)
  • MDI FD-10 automated bursting station
  • Nasal spray pump actuation station (eNSP, Mighty Runt)
• Pamasol hand crimper and vacuum crimper
• Pamasol pressure filler
• Spray View system for:
• • Plume geometry
  • Spray pattern
• Optronics imaging system for optical microscopy
• Humidity and temperature controlled testing rooms