Controlled Release

Let one team take control with world-class technology

As the premier innovator of coated, multi-particulate dosage forms, we offer an unsurpassed range of controlled-release capabilities in the development and manufacture services of oral solid tablets and hardshell capsules (including powders, pellets, beads, and granules). To build the strongest data package for your drug product early on in development, our formulation services team can help you proactively choose the most appropriate release capability for your requirements, thus easing integration into our complete lifecycle services and accelerating your timeline to market. Our vast experience working with potent compounds and organic solvents gives us the expertise to solve your most difficult API challenges and deliver a formulation package that meets current global regulatory standards.

Catalent Benefits 
  • Richest range of options for controlled-release formats 
  • Tablets 
    • Matrix tablets
    • Osmotic pump tablets
    • Bi-layer tablets
    • IR/SR/DR combos
    • 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
      • Including multi-particulate
    • Tablets in capsules 
  • Enhanced patient compliance  
  • Integrated preformulation services that provide expert support from preclinical stages through regulatory filing
  • Proven experience in project management
  • Manufacturing experience and track record, particularly around fluid bed technology
  • Global integrated network of state-of-the-art facilities 
 

Gastric protection

Compliance through reduced dose frequency

Improved pharmaco-kinetic profile

Child & senior dosage forms    

Functional enteric coating of tabs and caps

X

     

Coated multi-particulate dosage forms

X

X

X

X

Coated drug substance

X

 

X

X

Fixed dose combination tablets & capsules

 

X

X

X

Controlled release matrix tablets

 

X

X

 

Controlled release osmotic tablets

 

X

X

 

Stick pack and granules or liquids

     

X

         

 
How It Is Made

Our controlled-release development path is specifically designed to meet every possible challenge and parameter through the entire lifecycle of your product.

  • 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)
      • Allows for a decrease in dosing frequency that would be necessary if the product were in an immediate dose form
    • Sustained Release (SR)
      • Specific amounts of the drug released at timed intervals
    • Delayed or Enteric Release 
      • API released at a specific point in the body based on pH or other characteristic - depending on the drug profile
      • Drugs released in the intestines formulated to release at a higher pH (more basic) than that found in the stomach (more acidic)
    • Repeat Action or Pulsed Release 
      • Short-term and long-term action created by combining both immediate release and controlled release products - combined into one dose form 
  • Controlled-release properties
    • Incompatibility barrier
    • Temperature-controlled release
    • Taste-making
    • Delayed release
      • Enteric
      • Delayed “dump”
      • Pulsed
    • Sustained release
    • Combination profiles via multiparticulates and bilayer tablets
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
      • Project charter
      • Project quote
      • Signed quote
      • Customer PO
    • Planning
      • Kickoff meeting
      • Procurement
      • Batch records
      • Timeline development
    • Execution
      • Processing material
      • Material samples
      • Testing
    • Monitoring and controlling
      • Updated charter
      • Change control
      • Document control updating timeline
    • Closing/milestone completion
    • Invoices
      • Project summary
        • Reports
      • Closed meeting
Catalent Capabilities
  • Preformulation equipment 
    • X-ray powder diffraction 
      • Variable temperature 
      • RH
    • Thermal methods 
      • DSC
      • TGA 
      • TMA
    • Dynamic vapor sorption
    • Particle size analysis 
      • Wet/dry laser light
      • Sonic sieve
    • Microscopy 
      • Optical
      • Hot-stage
      • Image analysis
      • SEM
    • Intrinsic dissolution equipment
    • Analytical chemistry
      • HPLC specifications
      • UV specifications
      • FTIR specifications
    • Bulk testing
      • Powder flow
      • Hardness testing
      • Rheometers
  • Controlled-release equipment
    • Wet granulation
      • Fluid bed technology
      • High-shear granulation
      • Low-shear granulation
    • Dry granulation
      • Roller compaction
      • Slugging
    • Blending
    • Extrusion and spheronization
    • Milling
    • Tablet manufacturing process
      • Tablet press
    • Tablet and bead coating
      • Film
      • Beads, pellets, and granules
    • Hardshell-capsule filling process
      • Powder, granules, pellets, or beads prepared
      • Modified release attributes then altered at the granule level before being filled into a hardshell capsule
Facilities

Our three oral solids facilities have strong track records for both quality and regulatory compliance. 

  • Winchester, Kentucky, U.S.A.
    • Capabilities
      • Category I - III and solvent-based processing
      • Extrusion and spheronization
      • Commercial high-shear granulation
      • Blending
      • Tablet compression
      • Hardshell-capsule filling
      • Pan-coating
    • Compliance
      • Often noted by customers as one of Catalent’s top sites for quality and service
      • Over 98% on-time, in-full delivery performance for the past 3 years
      • Passed numerous pre-approval inspections by both U.S. and international regulatory authorities
  • Schorndorf, Germany
    • Capabilities
      • Category I - IV and solvent-based processing
      • Commercial high-shear granulation
      • Blending
      • Dry granulation
      • Extrusion and spheronization
      • Tablet compression
      • Hardshell-capsule filling
      • Pan-coating 
    • Compliance
      • Passed three FDA pre-approval inspections (PAI) and numerous inspections by national and international regulatory authorities
  • Somerset, New Jersey, U.S.A.
    • Capabilities
      • Preformulation
      • Non-sterile oral dosage form development
      • Analytical support for oral dosage form development
      • Small-scale commercial manufacturing for non-sterile oral dosage forms
      • Hardshell capsule filling
    • Compliance
      • Passed numerous pre-approval inspections by both U.S. and international regulatory authorities