Inhalation

The most choices and deepest expertise - across the pulmonary and nasal market

With over twenty years in inhalation product development, Catalent has the broadest range of development services across all inhaled dose forms. In fact, almost all pressurized metered-dose inhalers (pMDI) currently sold in the U.S. market have made use of our development and analytical services. We also provide global project and supply chain management to ensure a high-quality service delivery of your manufacturing and distribution needs. Backed by our vast experience with U.S. and European regulatory protocol as well as insights gained from working with industry expert groups such as EPAG, ITFG, and PQRI, we are able to accelerate your project so your investment arrives faster – and more efficiently – at market. 

Catalent Benefits

• Largest variety of dose forms available 
  • All dosage forms (pMDI, DPI, Nasal, solution/suspension, Nebulizer) 
• More inhalation product development experiences
  • Over 20 years of inhalation product development
  • Integrated services from preformulation to formulation, analytical testing, and clinical trial supply to commercial manufacturing and packaging
  • Accelerated product development through “fast-to-fail” process
  • Ample knowledge and insight gained through supporting industry expert groups (EPAG, ITFG, PQRI) 
• Extensive experience handling potent compounds and all controlled substances in Schedules I to IV 
  • Catalent development and analytical services used in almost all pMDI drugs in current U.S. market
• Reliable supply with a positive regulatory track record
  • Global project and supply chain management to ensure high-quality delivery
  • Thorough understanding of U.S. and European regulatory requirements and submission protocol
  • Assistance in defining submission strategies on Chemistry, Manufacturing and Controls (CMC) to avert potential issues by using the best possible solutions 
• Significant investments in top scientific talent, resources, and capacity

Catalent Services

To support your drug development, we offer a continuum of services so that you can reach clinical trial, and beyond.

• Dosage form selection and technology assessment
• Formulation development and analytical testing
• Supply of toxicological and clinical trial materials
• Clinical and commercial-scale manufacturing 
  • MDI, DPI, nasal sprays and nebulizer production lines
  • Class 10,000 space
  • Potent compound handling capabilities
  • DEA-controlled substances licenses
  • “Roll in - roll out” equipment and processes
• Packaging services
• Flexible manufacturing and warehousing services

Catalent Capabilities

To benefit your product from the concept stage, our preformulation capabilities include:

• Drug candidate screening, salt selection, and lead optimization
• Solubility in propellant and co-solvent systems
• Drug-exipient compatibility
• Formulation-container closure system compatibility
• Micrometric properties – particle size, density, flow, and more
• Solution/solid-state stability and characterization studies
• Method evaluation, optimization, and characterization studies
• Method transfer
• Particle size reduction (e.g., sub-contract micronization, spray, drying)
• Physico-chemical properties evaluation