Inhalation Overview

World-class expertise developing and manufacturing inhaled products.

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.  Catalent Pharma Solutions leverages decades of experience in the development, evaluation, and manufacture of inhalation products to accelerate and advance molecules and programs from the early phases of development through to commercial manufacturing.  Our operation integrates our knowledge and experience in preformulation sciences, formulation development, device evaluation/selection, performance testing, CMC, and manufacturing to reliably deliver all dosage forms relevant to an inhaled route of administration.  These include:

  • Pressurized metered dose inhalers (pMDIs)
  • Dry powder inhaler (DPIs)
  • Nasal spray
  • Solutions/suspensions for inhalation
Catalent Benefits
  • Deep inhalation-product development expertise
    • Decades of inhalation product development experience
    • Expertise in Quality-by-Design
    • Engaged with and influential among inhalation expert groups (like EPAG, ITFG, PQRI, IPAC-RS)
  • Wide breadth of capabilities for inhaled drug development
    • Dosage-form development (pMDI, DPI, Nasal, solution/suspension for inhalation)
    • Integrated services to speed the development process
      • Preformulation (physicochemical characterization, solid-state services, and structural chemistry)
      • Formulation Development, Device Evaluation/Selection, Product Performance Testing
      • Stability Services
    • Clinical and commercial-scale manufacturing of pMDIs, DPIs, and unit-/bi-dose nasal formulations.
  • 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) 
Catalent Services

As the leader in inhalation product development, we offer inhalation development services throughout your product's lifecycle: 

Preformulation

With the state-of-art technologies and a team of experienced and talented preformulation scientists (Optiform™ Technology) your product can be optimized for success. Our preformulation capabilities include a combination of proprietary instrumentation, industry-hardened workflows and expertise to provide a thorough assessment of the physical properties and enable selection of the best formulation options of your API.

Formulation

Catalent combines decades of project with all pulmonary dosage forms including pMDIs, DPIs, nasal sprays and solutions/suspensions for inhalation. Speed is delivered by workflows that have been continuously refined and applied to programs at all stages of development including:

  • Device evaluation/selection
  • Product-performance testing
  • Dosage-form selection and technology assessment

Pre-clinical, Clinical, and Commercial Manufacturing

Catalent offers flexible manufacturing solutions at scales suitable to reliably supply pre-clinical evaluation studies through to clinical studies and into the marketplace.  Our inhalation-manufacturing operations have a track-record of regulatory excellence, and we routinely manufacture pMDIs, DPIs, and nasal formulations for clients around the globe.

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