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Dry Powder Inhalers

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CATALENT BENEFITS

  • In-depth expertise and significant investment in talent and technologies across the entire inhalation field
  • Comprehensive services that can help expedite your product
  • Device selection and technology assessment
  • Formulation development and analytical testing
  • Supplying toxicological and clinical trial materials
  • Track record of regulatory success around the globe

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CATALENT SERVICES

  • Dosage form development
    • Powder evaluation and characterization
    • Formulation of low- and high-dose powder systems
    • Formulation of carrier-based or pure drug aggregated systems
    • Evaluation of moisture effects on powder properties, formulation stability, and aerosol performance
    • Device evaluation and selection
    • Characterization of aerosols
    • Device performance
    • cGMP compliance
  • Product testing
    • Powder evaluation and characterization
    • Formulation of low- and high-dose powder systems
    • Formulation of carrier-based or pure-drug aggregated systems
    • Evaluation of moisture effects on powder properties, formulation stability, and aerosol performance
    • Device evaluation and selection
    • Manufacturing validation support (process and cleaning validation)
    • Release and finished product testing
    • Aerodynamic & geometric particle sizing
    • Dose delivery
    • 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 for and nasal dosage forms and provide seamless technology transfer to our facilities, including:
      • Class 10,000 space
      • Potent compound handling capabilities
      • DEA-controlled substances licenses
      • Flexible manufacturing and warehouse space
      • “Roll in – roll out” equipment and processes
      • Warehousing
      • Vendor qualifications