Metered Dose Inhalers (MDIs)
EXTENSIVE SUPPORT FROM EARLY DEVELOPMENT THROUGH COMMERCIAL MANUFACTURE
OVERVIEW
Catalent Benefits Catalent Services
CATALENT BENEFITS
- Experience in commercializing HFA-based MDIs
- End-to-end development and manufacturing services to take your API from particle to patient
- Particle size reduction
- Material characterization
- Formulation feasibility
- Product development
- Process development
- Clinical-scale manufacture
- Clinical-supply services
- Commercial-scale manufacture
- Packaging QC / Release testing
- Deep inhalation product development expertise
- Decades of inhalation product development experience
- Expertise in Quality-by-Design
- Engaged with and influential among inhalation expert groups
- Integrated preformulation and formulation services
- Development across all common dosage forms (MDI, Nebules, Nasal, DPI)
- Reliably supplied with an exemplary regulatory track record
- Global project and supply chain management to ensure high-quality delivery
- Thorough understanding of U.S. and European regulatory requirements for both generic and new chemical entity drug-device combination products
- Assistance in defining submission strategies on Chemistry, Manufacturing and Controls (CMC)
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)
- Release and finished product testing
- Particle size distribution
- Next Generation Pharmaceutical Impactor (NGI)
- Anderson Cascade Impactor (ACI)
- MDI plume geometry
- Spray and droplet analysis
- Automated actuators
- Thermogravimetric 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 and provide seamless technology transfer to our commercial manufacturing facilities:
- Class 10,000 space
- Cannister filling and packaging
- Potent compound handling capabilities
- DEA-controlled substances licenses
- Flexible manufacturing and warehouse space
- Warehousing
- Vendor qualifications
- Complete clinical trials materials preparation in support of Phase I – IV studies and provide seamless technology transfer to our commercial manufacturing facilities: