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Nasal Sprays

UNIT/BI-DOSE NASAL SPRAY DEVELOPMENT AND MANUFACTURE

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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 from concept to market
    • Dosage form selection and technology assessment
    • Formulation development and analytical testing
    • Supplying toxicological and clinical trial materials
    • Commercial-scale manufacturing
    • Track record of regulatory success around the globe

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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)
    • In-vitro bioequivalence testing
    • Release and finished product testing
    • Particle sizing, droplet sizing and spray 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 for nasal dosage forms and provide seamless technology transfer to our commercial manufacturing facilities:
      • Class 10,000 space
      • Potent compound handling capabilities
      • DEA-controlled substances licenses
      • Flexible manufacturing and warehouse space
      • Customized facilities built to suit
      • Both sterile and preserved production capabilities
      • “Roll in – roll out” equipment and processes
      • Warehousing
      • Vendor qualifications