Inhalation

The most choices & deepest expertise - across the inhalation 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

• Widest breadth of service capabilities for inhaled drug development
  • All dosage forms (pMDI, DPI, nasal, solution/suspension, Nebulizer)
  • Integrated services from preformulation to formulation, analytical testing, and clinical trial supply to commercial manufacturing and packaging
• More inhalation product development experiences
  • Over 2 decades of inhalation product development
  • 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 exemplary regulatory track record
  • Global project and supply chain management to ensure high-quality delivery
  • Thorough understanding of U.S. and European regulatory requirements and submissions protocol
  • Assistance in defining submission strategies in Chemistry, Manufacturing and Controls (CMC) to avert potential failure
• Significant investments in top scientific talent, resources, and capacity

Catalent Services

We can provide the expertise you need for dosage form selection and technology assessment; formulation development and analytical testing; and toxicological and clinical supply trial materials.

• Dosage form and device selection 
  • Matching drug characteristics with the best inhalation dosage form
• Pressurized metered dose inhalers 
  • Formulation selection and optimization
  • Canister, valve, and actuator selection
  • Spacer and add-on device testing
• Dry powder inhalers 
  • 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
• Nasal sprays 
  • Formulation selection and optimization
  • Pump and container selection
  • In-vitro bioequivalence testing
  • Laboratory - scale filling
• Solutions and suspensions for inhalation 
  • Formulation selection and optimization
  • Container selection
  • Aerosol characterization of formulation/nebulizer system combinations

Catalent Capabilities

Having faced many of the same challenges you face today, our analytical teams offer an insider's knowledge of complex testing processes and procedures. This complements our product development and aids our understanding of test methods versus product-specific troubleshooting. Our testing services include:

• A wide range of laboratory space featuring flexible configurations
• Controlled temperature and humidity laboratories
• 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