OFFERINGS

Dry Powder Inhalants

Comprehensive services from dosage form to clinical trial

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
- 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
- Technical requirements
- Characterization of aerosols
- Device performance
- cGMP compliance
Product testing
- Manufacturing validation support (process and cleaning validation)
- Release and finished product testing
- Particle 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 provide seamless technology transfer to our commercial manufacturing facilities, including:
  - 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
  - “Roll in – roll out” equipment and processes
  - Warehousing
  - Vendor qualifications