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Metered Dose Inhalers (MDIs)

EXTENSIVE SUPPORT FROM EARLY DEVELOPMENT THROUGH COMMERCIAL MANUFACTURE

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CATALENT BENEFITS

  • Experience in commercializing HFA-based MDIs
  • End-to-end development and manufacturing services to take your API from particle to patient
    • Particle size reduction
    • Material characterization
    • Formulation feasibility
    • Product development
    • Process development
    • Clinical-scale manufacture
    • Clinical-supply services
    • Commercial-scale manufacture
    • Packaging QC / Release testing
  • Deep inhalation product development expertise
    • Decades of inhalation product development experience
    • Expertise in Quality-by-Design
    • Engaged with and influential among inhalation expert groups
    • Integrated preformulation and formulation services
    • Development across all common dosage forms (MDI, Nebules, Nasal, DPI)
  • Reliably supplied with an exemplary regulatory track record
    • Global project and supply chain management to ensure high-quality delivery
    • Thorough understanding of U.S. and European regulatory requirements for both generic and new chemical entity drug-device combination products
    • Assistance in defining submission strategies on Chemistry, Manufacturing and Controls (CMC)

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CATALENT SERVICES

  • Dosage form development
    • Formulation selection and optimization
    • Characterization of aerosols
    • Device performance
    • Pump and container selection
    • cGMP compliance
  • Product testing
    • Manufacturing validation support (process and cleaning validation)
    • Release and finished product testing
    • Particle size distribution
      • Next Generation Pharmaceutical Impactor (NGI)
      • Anderson Cascade Impactor (ACI)
    • MDI plume geometry
    • Spray and droplet analysis
    • Automated actuators
    • Thermogravimetric analysis
    • Drug and delivery assays
    • Stability studies (ICH and custom conditions)
    • Structural elucidation of drug-related impurities and degradation products
    • Extractables and leachables studies
  • Clinical and commercial manufacturing
    • Complete clinical trials materials preparation in support of Phase I – IV studies and provide seamless technology transfer to our commercial manufacturing facilities:
      • Class 10,000 space
      • Cannister filling and packaging
      • Potent compound handling capabilities
      • DEA-controlled substances licenses
      • Flexible manufacturing and warehouse space
      • Warehousing
      • Vendor qualifications