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Controlled Release Delivery
THE MOST DOSAGE SOLUTIONS FROM THE INDUSTRY’S LEADING INNOVATOR

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.

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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

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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

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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)
  • Sustained release (SR)
  • Delayed or enteric release
  • Repeat action or pulsed release

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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
  • Planning
  • Execution
  • Monitoring and controlling
  • Closing/milestone completion

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CATALENT CAPABILITIES

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

Tablets

  • Matrix tablet
  • Osmotic tablets
  • Bi-layer tablets
  • 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
  • Tablets in capsules

Equipment

  • Wet granulation
  • Dry granulation
  • Blending
  • Extrusion and spheronization
  • Milling
  • Tablet manufacturing process
  • Tablet and bead coating
  • Hardshell capsule filling process

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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