Inhalation Development & Analytical

OVERVIEW

Why Catalent?      Catalent Services

Catalent leverages decades of experience in the development and evaluation of inhalation products to provide turn-key solutions, focused on driving effective regulatory submissions. As a top drug manufacturer, Catalent performs analytical services through the lens of facilitating the next stage of clinical or commercial development.

Catalent helps develop or test a wide-range of inhalation products:

• Dry Powder Inhalers (DPIs)
• Unit/Bi-Dose Liquid Nasal Sprays
• Nebulized Solutions, Suspensions or Emulsions
• Multidose Liquid Nasal Sprays
• Unit-Dose Nasal Powder

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WHY CATALENT?

Catalent provides end-to-end support for inhalation products, from early preformulation work to finished product release testing. Our industry-recognized technical experts can work with a broad array of dose forms.

• Over 30 years of experience in supporting inhalation product development
• Nearly 70,000 square feet of lab space between our Morrisville/RTP, NC and Boston, MA facilities
• Development work from the same team that supports integrated manufacturing projects means dossier-ready reports and a regulatory submission-oriented approach
• Dedicated personnel throughout project lifecycle
• Available in-house regulatory support and consulting services
• Ability to handle all DEA controlled substances (Schedules I-V) and safety levels (BSL-1 to BSL-4) at our Morrisville/RTP, NC location
• Support for potent and highly potent APIs as well as light, temperature, moisture and oxygen-sensitive compounds
• Leveraging the support of Catalent’s Scientific Resource Center (SRC), a global scientific network of over 2,400 researchers in 10 countries

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CATALENT SERVICES

As a leader in the development and characterization of inhalation products, we are able to provide the analytical support services throughout your product’s lifecycle:

Preformulation
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

Formulation
Catalent has decades of experience with all pulmonary and nasal dosage forms including 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)

Device Assessment
For over 30 years, our inhalation development team has helped customers select the optimal final dose form. As Catalent supports development across inhaled dose forms and device manufacturers, customers can feel secure that the recommended format is the best fit for the API and formulation as well as the patient.

• Device evaluation, selection and testing

Analytical Testing and Related Services
Catalent’s global analytical center-of-excellence, operating out of the Morrisville/RTP, NCfacility, is located alongside our inhalation development team, providing critical early-to-late-stage API, formulation and drug product characterization services. With more than 7,000 cubic feet of stability storage capacity and industry-recognized experts, Catalent supports a broad range of analytical services:

• • Method Development & Validation – From dissolution testing and residual solvents to method transfer, qualification and troubleshooting
  • Stability Testing & Storage – Comprehensive testing options from prototype and temperature excursion to forced-degradation and photostability, with diverse storage conditions and support for potent and controlled substances
  • Solid State Screening – Early stage screening and characterization to scale-up crystallization process development and single-crystal growth and structure determination

• Extractables & Leachables (E&L) – Controlled extraction, unknown identification, migration and simulation studies, leachable stability & release, evaluation of byproducts and evaluation of in-process testing
• Elemental Impurities – Inorganic spectroscopy solutions for screening services, development and validation (ICH Q3D), risk assessment testing and process chemistry support
• Organic Spectroscopy – Impurity/degradant identification, reference material characterization and manufacturing support
• Quality Control (QC) / Compendial Analysis – Testing of incoming raw materials in accordance with regulatory authorities, residual solvents, in-process testing and nitrogen testing
• Microbiological Assessment – Testing API and drug product for microbial enumeration, sterility and endotoxin assessment

Final Product Characterization and Release Testing
Catalent is equipped with a broad array of specialized inhalation testing equipment and has the niche experts to effectively characterize the final drug product, regardless of dose form, to assure accurate and consistent drug delivery.

• Particle size distribution / Impaction testing (NGI/ACI)
• Plume geometry, spray pattern, droplet size
• Breath simulation and automated actuation
• Dose delivery and uniformity
• HIAC foreign particulate matter
• Thermogravimetric analysis & Dynamic vapor sorption (DVS)