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Catalent Pharma Solutions leverages decades of experience in the development, evaluation, and manufacture of inhalation products to advance and accelerate molecules from early development through commercial manufacturing. Our operation integrates our knowledge and experience in preformulation sciences, formulation development, device evaluation/selection, CMC, manufacturing and product characterization to reliably deliver therapies across all common inhalation dosage forms:

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  • End-to-end development and manufacturing services to take your API from particle to patient
    • Particle size reduction
    • Material characterization
    • Formulation feasibility
    • Product development
    • Process development
    • Clinical-scale manufacture
    • Clinical-supply services
    • Commercial-scale manufacture
    • Packaging
    • QC / Release testing
  • Deep inhalation product development expertise
    • Decades of inhalation product development experience
    • Expertise in Quality-by-Design
    • Engaged with and influential among inhalation expert groups
    • Integrated preformulation and formulation services
    • Development across all common dosage forms (MDI, Nebules, Nasal, DPI)
  • 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 for both generic and new chemical entity drug-device combination products
    • Assistance in defining submission strategies on Chemistry, Manufacturing and Controls (CMC)

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As a leader in inhalation product development, we offer development services throughout your product’s lifecycle:

With the state-of-art technologies and a team of experienced and talented preformulation scientists, 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.

  • Physicochemical characterization
  • Solid-state services
  • Structural chemistry

Catalent combines decades of project with all pulmonary and nasal dosage forms including MDIs, 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:

  • Formulation feasibility, development and optimization
  • Dosage-form selection and technology assessment
  • Container and formulation compatibility
  • De-formulation and comparator product characterization (e.g. generics)

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 complex and demanding formulations for clients around the globe.

  • Commercial-scale manufacturing: MDI and Blow-Fill-Seal nebules
  • Clinical-scale manufacturing: MDI, Unit/Bi-dose Nasal Spray, DPI and Blow-Fill-Seal nebules

Characterization and Analytical Services
Catalent Pharma Solutions distinguishes itself in the CDMO industry by offering a comprehensive suite of integrated analytical services from initial material characterization through release testing, without the need to subcontract projects to third parties. This provides better project visibility to the customer, a single point of contact and ultimately reduces project costs and development timelines.