Inhalant Solutions / Suspensions

Expertise from Formulation to Commercial-Scale Manufacturing

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
    • Packaging services
  • Track record of regulatory success around the globe
Catalent Services
  • Dosage form development
    • Formulation selection and optimization
    • Technical requirements
    • 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 
    • Article 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 – world-renowned scientific staff
  • Clinical and commercial manufacturing
    • Complete clinical trials materials preparation in support of Phase I - IV studies for all pulmonary and nasal dosage forms and seamless technology transfer to our commercial manufacturing facilities:
      • MDI, DPI, nasal sprays, and nebulizer production capabilities 
      • Fully automated MDI production lines 
      • 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