Nasal Sprays
UNIT/BI-DOSE NASAL SPRAY DEVELOPMENT AND MANUFACTURE
OVERVIEW
Catalent Benefits Catalent Services
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
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
- 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:
