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  6.  » Modified Release Formulations

Modified Release Formulations


Catalent has extensive capabilities and deep expertise to be your go to partner for all oral modified release delivery solutions including controlled, sustained, delayed, and pulsatile release.

With robust experience in the development and manufacture of oral controlled release delivery formats, Catalent has launched over 50 products spanning U.S., Europe, and major Asian markets.

Catalent’s scientific advisors provide technical guidance and expertise on the key attributes that determine whether a compound is suitable for modified release formulation, at every stage of development. By matching each project to a knowledgeable and experienced team, Catalent can help develop the right solution to get your product into the clinic, provide reliable ongoing supply and scale up thru CMC and to patients .

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  • Proven track record in developing modified release dosage forms
  • Access to innovative and proven immediate-release and modified-release formulation and processing technologies
  • Physiological based pharmacokinetic (PBPK) modeling expertise to determine API feasibility for controlled/sustained release and to support formulation development
  • Dedicated scientific advisors and project management expertise
  • Integrated services across the entire product lifecycle
  • Efficient internal technology transfer to scale up capacity from laboratory to pilot plant to commercial production.

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Consider working with us from preformulation through to supply to best meet your delivery needs and minimize your costs:

Preformulation capabilities

  • Differential scanning calorimetry
  • X-ray powder diffraction
  • Dynamic vapor sorption
  • Infrared spectroscopy
  • Particle size analysis
  • Particle physical properties
  • Scanning electron microscopy

Formulation capabilities

  • Method development and validation
  • Stability testing
  • Assay and impurities
  • Dissolution profile

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


  • Full scale

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Modified release process

  • Polymers are used to control the release of the API from the formulation through one of two approaches:
    • Coating of tablets or multiparticulates
    • Development of matrix tablets or multiparticulates with or without additional coatings
  • Release of the API dependent on the type of polymer and strategy used to produce the finished product

Modified release types

  • Extended release (XR) or long-acting (LA)
  • Sustained release (SR)
  • Controlled release (CR)
  • Delayed release (DR)
  • Enteric coating
  • Repeat action or pulsatile release

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Key process technologies

  • Fluid bed drying
  • Top spray granulation process
  • Wurster HS coating
  • Rotor processing
  • High shear mixing
  • Pan-coating
  • Extrusion Spheronization
  • Twin screw wet granulation
  • Twin melt granulation
  • Hot melt extrusion
  • Laser Drilling

Highly efficient project management

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

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Catalent is highly experienced in manufacturing the following:


  • Matrix tablets
  • Film coated tablets
  • Osmotic tablets
  • Bi-layer tablets
  • Tri-layer tablets
  • Traditional tablets

Coated pellets/beads

  • High-potency pellets
  • Drug-layered spheres
  • Taste mask particles
  • Modified release pellets


  • Immediate release powder-in-a-capsule
  • API-in-a-capsule
  • Beads for CR
  • Tablets in capsules


  • Wet granulation
  • Dry granulation
  • Blending
  • Extrusion and spheronization
  • Twin Screw Extruder
  • Milling
  • Tablet manufacturing process
  • Tablet and bead coating
  • Hard-shell capsule filling process

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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