The Pharmaceutical Development business of Catalent Pharma Solutions offers comprehensive product development services to help take your inhaled product from concept through regulatory approval. Our team has experience with all inhalation dosage forms – pressurized metered dose inhalers (pMDIs), dry powder inhalers (DPIs), nasal sprays and solutions for inhalation.
We can provide the expertise you need for dosage form selection and technology assessment; formulation development and analytical testing; and supplying toxicological and clinical trial materials.
For capabilities that meet your needs, and outcomes that exceed your expectations, partner with Catalent today. For more information fill out our Contact us form or call a member of our sales staff toll-free at 866.720.3148.
Formulation
- 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
Product testing
Our analytical teams have faced many of the same challenges you face today. We 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:
- A 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
For capabilities that meet your needs, and outcomes that exceed your expectations, partner with Catalent today. For more information fill out our Contact us form or call a member of our sales staff toll-free at 866.720.3148.