Controlled Release Delivery
THE MOST DOSAGE SOLUTIONS FROM THE INDUSTRY’S LEADING INNOVATOR
Catalent is the most reliable brand of choice for all controlled release oral delivery solutions. With more than 15 years of experience launching over 50 products in all major American, European, and Asian markets, we continue to produce the most dosage-form solutions with superior quality and utmost efficiency. As a solutions-oriented service organization, we recognize that our success depends upon your success. Accordingly, we match each project with a competent, enthusiastic team to ensure all work is performed according to your timeline and budget. Whether you seek controlled-release technology to manage your product’s lifecycle in the marketplace or want a specific clinical, pharmacodynamics, or pharmacokinetic profile, we can help you achieve your desired outcome – every time, all the time.CATALENT BENEFITS
- Cutting-edge expertise reliably proven over 15 years
- Innovative, advanced immediate-release and modified-release formulation and process technologies
- Most dosage-form solutions
- Tablets, capsules and other formulations for sustained/modified drug substance release
- Dedicated project management
- Integrated services across the entire lifecycle of product
- Internal technology transfer from laboratory to pilot plant to commercial production
HOW IT IS MADE
Consider working with us from preformulation through supply to best meet your delivery needs and minimize your costs:
Preformulation
- Thermal
- XRD
- Moisture
- IR
- Particle size
- Particle physical properties
Formulation
- Method development and validation
- Stability testing
- Assay and impurities
- Dissolution profile
Process feasibility
- Key process parameters identified
Process scale-up
- Key process parameters identified
- Batch record drafted
Process demonstration
- Batch records
- Performance trending
- Compliant material for human use
Clinical supplies
- Compliant material for human use
Registration batches
- 1/10 scale or 100,000 unit yield minimum
Validation batch manufacture
- Full scale and at least 3 batches
Commercial
- Full scale
HOW IT WORKS
Controlled Release process
- Polymers used to coat tablets and beads or drug particles in capsules
- Dissolution of coating releases the API over time
Controlled Release types
- Extended release (XR) or long-acting (LA)
- Sustained release (SR)
- Delayed or enteric release
- Repeat action or pulsed release
CATALENT SERVICES
Key process technologies
- Fluid bed drying
- Top spray processing
- Wurster HS processing
- Rotor processing
- High shear processing
- Pan-coating
Highly efficient project management
- Initiation
- Planning
- Execution
- Monitoring and controlling
- Closing/milestone completion
CATALENT CAPABILITIES
Catalent is highly experienced in manufacturing controlled release in the following:
Tablets
- Matrix tablet
- Osmotic tablets
- Bi-layer tablets
- Traditional tablets
Coated pellets/beads
- High-potency pellets
- Drug-layered spheres
- Taste mask particles
Capsules
- IR powder in a capsules
- API in a capsule (Xcelodose®)
- Beads for CR
- Tablets in capsules
Equipment
- Wet granulation
- Dry granulation
- Blending
- Extrusion and spheronization
- Milling
- Tablet manufacturing process
- Tablet and bead coating
- Hardshell capsule filling process
FACILITIES
Our five oral solid dosage facilities have strong track records for both quality and regulatory compliance.
Winchester, KY, USA
Schorndorf, Germany
Somerset, NJ, USA
Nottingham, UK
San Diego, CA, USA
