Preformulation



Inhalation Preformulation

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

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.

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 and evaluation
  • Salt and polymorph screening and selection
  • Physical properties evaluation of the API (pXRD, thermal properties, moisture-sorption)
  • Solubility screening in propellant and co-solvent systems
  • Solution and solid-state stability
  • Drug-excipient compatibility
  • Formulation-container closure system compatibility
  • Bulk properties (e.g., bulk and tap density, angle-of-repose)
  • Micrometric properties (e.g., particle size, particle morphology, and flow)
  • Chromatographic method evaluation, optimization, and characterization studies
  • Particle size reduction (e.g., sub-contract micronization, spray, drying)