Modified Release Formulations
Catalent has extensive capabilities and deep expertise to be your go to partner for all oral modified release delivery solutions including controlled, sustained, delayed, and pulsatile release.
Catalent’s scientific advisors provide technical guidance and expertise on the key attributes that determine whether a compound is suitable for modified release formulation, at every stage of development. By matching each project to a knowledgeable and experienced team, Catalent can help develop the right solution to get your product into the clinic, provide reliable ongoing supply and scale up thru CMC and to patients .
CATALENT BENEFITS
- Proven track record in developing modified release dosage forms
- Access to innovative and proven immediate-release and modified-release formulation and processing technologies
- Physiological based pharmacokinetic (PBPK) modeling expertise to determine API feasibility for controlled/sustained release and to support formulation development
- Dedicated scientific advisors and project management expertise
- Integrated services across the entire product lifecycle
- Efficient internal technology transfer to scale up capacity from laboratory to pilot plant to commercial production.
HOW IT IS MADE
Consider working with us from preformulation through to supply to best meet your delivery needs and minimize your costs:
Preformulation capabilities
- Differential scanning calorimetry
- X-ray powder diffraction
- Dynamic vapor sorption
- Infrared spectroscopy
- Particle size analysis
- Particle physical properties
- Scanning electron microscopy
Formulation capabilities
- Method development and validation
- Stability testing
- Assay and impurities
- Dissolution profile
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
Modified release process
- Polymers are used to control the release of the API from the formulation through one of two approaches:
- Coating of tablets or multiparticulates
- Development of matrix tablets or multiparticulates with or without additional coatings
- Release of the API dependent on the type of polymer and strategy used to produce the finished product
Modified release types
- Extended release (XR) or long-acting (LA)
- Sustained release (SR)
- Controlled release (CR)
- Delayed release (DR)
- Enteric coating
- Repeat action or pulsatile release
CATALENT SERVICES
Key process technologies
- Fluid bed drying
- Top spray granulation process
- Wurster HS coating
- Rotor processing
- High shear mixing
- Pan-coating
- Extrusion Spheronization
- Twin screw wet granulation
- Twin melt granulation
- Hot melt extrusion
- Laser Drilling
Highly efficient project management
- Initiation
- Planning
- Execution
- Monitoring and controlling
- Closing/milestone completion
CATALENT CAPABILITIES
Catalent is highly experienced in manufacturing the following:
Tablets
- Matrix tablets
- Film coated tablets
- Osmotic tablets
- Bi-layer tablets
- Tri-layer tablets
- Traditional tablets
Coated pellets/beads
- High-potency pellets
- Drug-layered spheres
- Taste mask particles
- Modified release pellets
Capsules
- Immediate release powder-in-a-capsule
- API-in-a-capsule
- Beads for CR
- Tablets in capsules
Equipment
- Wet granulation
- Dry granulation
- Blending
- Extrusion and spheronization
- Twin Screw Extruder
- Milling
- Tablet manufacturing process
- Tablet and bead coating
- Hard-shell 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
