Controlled Release

Optimized Oral Dose Product Performance

11-VARIETY-S-Catalent-0578 v2

We offer a complete range of controlled release capabilities for tablets, capsule development, and manufacture. 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 empower your controlled-release success on every level. As we have the capacity to enter into your process at any stage of your product’s lifecycle, we encourage you to consider controlled-release capabilities early in development to proactively increase your product’s value, enhance patient compliance, and maximize your investment. With extensive experience working with potent and complex compounds, we aim to develop controlled-release formulations and processes that are scalable, economical, and easy to manufacture, with the end goal of shortening your time to market. 

Our controlled-release technologies and oral solids capability offers formulation, development, and manufacturing services for both oral solid tablets and hardshell capsules, as well as powders, pellets, beads, and granules. 

Catalent Benefits 

Customers are drawn to our controlled-release expertise and capabilities across the entire lifecycle of products: 

  • Unsurpassed capacity, quality, and formats  
  • Complete range of controlled-release capabilities for tablets, capsule development, and manufacture
  • Added expertise working with potent APIs, nonchlorinated solvents, and all schedules of DEA-controlled substances 
  • Smart lifecycle management at every stage
  • Manufacturing experience and track record, particularly around fluid bed technology

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”
      • Pulse
    • 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
Catalent Capabilities

Catalent is highly experienced in producing controlled-release technologies for the following: 

  • Tablets
    • Matrix tablets
    • 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 capsule
    • 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 delivery 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 - IVV 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