Controlled Release Delivery

The most dosage solutions from the industry’s leading innovator

43-VARIETY-S-Catalent-0591 v2

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)
      • 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