Formulation



Inhalation Formulation

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

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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.  Our scientists, the engine that powers our operation, is balanced with expertise in physical chemistry, analytical chemistry, formulation development, process development, process scale-up, and manufacturing.  We have the talent to drive your program’s success.

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:

  • 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
  • Spray-pattern and plume-geometry
  • Device performance
  • Pump and container selection (nasal formulation)
  • Release and finished product testing
  • Particle sizing (microscopy and laser-diffraction methods)
  • Drug and delivery assays
  • In-vitro bioequivalence testing
  • Stability studies (ICH and custom conditions)
  • Structural elucidation of drug-related impurities and degradation products 
  • Extractables and Leachables