Inhalation

The broadest range of development services across all inhaled dose forms

For global pharmaceutical companies with inhaled drug pipelines, Catalent is your service solutions partner that enables you to enhance the value of your treatment and improve your product’s speed to market. 

Particularly effective in the treatment of respiratory conditions, such as asthma, sinusitis, and Chronic Obstructive Pulmonary Disease (COPD), drug delivery by inhalation has numerous advantages, including its ability to precisely target a diseased area (bypassing the gastrointestinal tract and thus minimizing systemic absorption). As a number of therapeutic drug classes are currently under investigation as candidates for delivery via inhalation devices, Catalent stands ready to respond with the broadest range of development services across all inhaled dose forms and a proven track record advancing inhalation products to market.

From preformulation to clinical manufacturing, our team can provide the expertise you need for dosage form selection and technology assessment; formulation development and analytical testing; and supply of toxicological and clinical trial materials. Our experience covers all inhaled dose forms:

• Pressurized metered dose inhalers (pMDIs)
• Dry powder inhaler (DPIs)
• Nasal spray
• Solutions/suspensions for inhalation

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, clinical trial supply and packaging
• More inhalation product development experiences
  • Over 20 years of inhalation product development experiences
  • Catalent development and analytical services used in almost all pMDI drugs in current U.S. market
  • Accelerated product development through “fast-to-fail” process
  • Ample knowledge and insight gained through supporting industry expert groups (EPAG, ITFG, PQRI)
• 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 and submission protocol
  • Assistance in defining submission strategies on Chemistry, Manufacturing and Controls (CMC) to avert potential issues by using the best possible solutions

Catalent Services

As the world’s leading provider of inhalation product development, manufacturing, and packaging, we offer comprehensive inhalation development services throughout all stages of your product's lifecycle: 

• Dosage form selection and technology assessment 
• Formulation development and analytical testing 
• Supply of toxicological and clinical trial materials
• Commercial-scale manufacturing
• Packaging services

Our team has extensive experience with all inhalation dosage forms:

• Pressurized metered-dose inhalers (pMDIs)
• Dry powder inhalers (DPIs)
• Nasal sprays and solutions/suspensions for inhalation
• Nebulizers and liquid inhalers

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. 

• Product testing
  • 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
• Clinical and commercial manufacturing
  • We offer complete clinical trial materials preparation in support of Phase I - IV studies for all inhalation 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
    • Build to suit
    • “Roll in – roll out” equipment and processes
    • Warehousing
    • Vendor qualifications