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Inhaled Pharmaceuticals Experience


Breathe easier knowing you can rely on PPD® Laboratories for your next inhaled pharmaceutical program.

Developing medicines that are delivered via the pulmonary and nasal routes for the treatment of local and systemic diseases is challenging. While the demonstration of safety, potency and purity is a fundamental part of the marketing authorization process for all drugs, incorporation of a delivery device greatly increases the complexity of the drug development process.

PPD® Laboratories GMP lab has been supporting the respiratory community across the product development continuum for more than 18 years. We have depth of experience evaluating drug/device combinations, and see continued growth in novel combinations and multi-active medicinal products.

In the past 10 years we have supported the development of more than 100 inhaled products of which at least 10 have received approval for commercialization by regulatory bodies.

Our experience with inhaled pharmaceuticals includes:

  • 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 drug products include:

  • Formulation evaluation studies
  • Drug product characterization studies: device robustness, dosing orientations, effect of resting times and others
  • Full extractables and leachables program support for container/closure systems
  • Drug content/stability assay development, optimization, validation, qualification and transfer
  • Stability, release and QC testing
  • Physicochemical characteristics for drug product and device
  • Dose content uniformity and emitted dose performance
  • Foreign particulate matter, impurities, degradation products and preservatives
  • Container/closure integrity including leak rate
  • Microscopic evaluation
  • Particle size, shape and distribution
  • Plume geometry and spray pattern

Key specialized facilities and instrumentation include:

  • Andersen cascade impactors
  • Clemex PS3 particle sizing system
  • Copley Scientific inhaler testing data analysis software (CITDAS), Model TPK critical-flow controller
  • HIAC Royco particulate matter analyzer
  • PPD-patented dose collection tubes used to analyze foreign particulate matter from pMDI and DPI products
  • Horiba particle-size analyzer
  • Humidity and temperature controlled testing rooms in Middleton and Athlone
  • Innova Systems nasal dose weight with collection station (NSP-DWC)
  • Malvern Spraytec droplet-size analyzer
  • Marple-Miller ImpactorM150
  • MDI FD-10 automated bursting station, nasal spray pump actuation station (Mighty Runt, NSP UA)
  • Multistage liquid impinger (MSLI)
  • Next generation impactors (NGI)
  • Optronics imaging system for optical microscopy
  • Pamasol hand crimper, vacuum crimper and pressure filler
  • SprayView® system for plume geometry and spray pattern
  • TSI digital flow meters


Explore our experience:

  • Small Molecule
  • Biologics
  • Satellite Solutions

 

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