Controlled Release Manufacturing

Superior, efficient clinical supply – from small to full scale

As the premier innovator of coated multi-particulate dosage forms and a world leader in the production of coated beads and tablets, we bring years of experience and a network of FDA-compliant facilities to meet your controlled release manufacturing needs. Our goal is to provide you with high-quality product, efficiently managed, delivered on time.  From small-scale clinical supply lots to full-scale production, we effectively utilize our integrated internal resources across the entire lifecycle of your product to reduce your costs, minimize your capital outlay, and maximize your time to market. 

As a solutions-oriented service organization, we recognize that our success depends upon your success. Accordingly, we offer each project a competent, enthusiastic team, providing the personal service and attention necessary to assure all work is performed according to your timeline and budget. 

Catalent Benefits

Your outsourcing dollars, when invested with Catalent’s services, produce the following values:

  • Innovative, advanced immediate-release and modified-release formulation and process technologies
  • Creative, responsive, flexible full-service extension of your business strategy
  • Internal technology transfer from laboratory to pilot plant to commercial production
  • Relief for customer R&D resource constraints
  • Reduced manufacturing costs
  • Ability to adjust to variable market demand
  • Reduced capital outlay 
  • Reduced time to market
How It Is Made 

Consider working with us from preformulation through supply to fully leverage our expertise and minimize your manufacturing 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)
      • 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 
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

Catalent is highly experienced in manufacturing controlled release in the following:

  • Tablets
    • Matrix tablet
    • Osmotic 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
  • 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.
    • High reputation for service and compliance
    • Often noted by customers as one of Catalent’s top sites for quality and service
    • Over 98% on-time, in full deliver performance for the past 3 years
    • Passed numerous pre-approval inspections by both U.S. and international regulatory authorities
    • Services
    • Category I-III and solvent-based processing
    • Extrusion and spheronization
    • Commercial high shear granulation
    • Blending
    • Tablet compression
    • Hardshell capsule filling
    • Pan-coating
  • Schorndorf, Germany
    • Notable standards of compliance
    • Passed three FDA pre-approval inspections (PAI) and numerous inspections by national and international regulatory authorities
    • Services
    • Category I-IV and solvent-based processing
    • Commercial high-shear granulation
    • Blending
    • Dry granulation
    • Extrusion and spheronization
    • Tablet compression
    • Hardshell-capsule filling
    • Pan-coating 
  • Somerset, New Jersey, U.S.A.
    • Strong compliance
    • Passed numerous pre-approval inspections by both U.S. and international regulatory authorities
    • Services
    • Commercial and development
    • Hardshell-capsule filling