Hard Shell Capsules

Development and manufacturing solutions with a competitive edge

9-CAPSULES-S-Catalent-0537-v2

As the premier innovator of coated multi-particulate dosage forms, we also offer expert development and manufacturing services for hardshell capsules (HSC), as well as oral solid tablets, powders, pellets, beads, and granules. An HSC is a tasteless capsule that consists of a hard-gelatin shell and cap that fit together and “lock.”  Capable of decreasing the possibility for tablet compression (particularly helpful in early oral dose-form clinical trials), HSCs can be matched to our wide range of release options and are relatively easy to manufacture. Backed by our vast experience in working with potent APIs, non-chlorinated organic solvents, and all schedules of DEA-controlled substances as well as our manufacturing expertise - in particular, around fluid bed technology - we can help your HSC meet its therapeutic requirements and stand out in a highly competitive market.

Catalent Benefits 
  • Integrated services from development to market
    • Preformulation and formulation expertise solving numerous challenges
    • Innovative proprietary release technologies that optimize delivery
    • Network of FDA-compliant facilities
    • Project management teams with on-point contact
    • Reliable, customized clinical supply
    • Track record of regulatory success in NDAs and ANDAs
  • Extensive expertise, experience, and capacity for full-scale production
    • Range of HSC production choices
      • Clear or colored
      • Distinct fillings: powder, granules or pellets
      • Encapsulate some liquids into HSCs using our softgel technology
Valuable Product Differentiation 
  • Capsule characteristics
    • Immediate release powder in a capsule
    • API in a capsule (Xcelodose®* )
    • Beads for controlled release, including multi-particulate
    • Tablets in capsules
  • Dose release options
    • Immediate Release
    • Modified Release
      • Controlled Release
      • Delayed Release/Enteric Release
      • Repeat Action or Pulse Release
    • Proprietary technologies
      • Zydis® fast dissolve 
        • The no. 1 oral disintegrating tablet that enhances pre-gastric absorption
Catalent Capabilities

Controlled substance processing:

  • Capability of ordering, storing, testing, and processing of DEA Schedules II – V
  • Significant experience processing controlled release morphine analogs and amphetamines
  • Tablet and capsule dosage forms
  • 24/7 security
  • Video surveillance of processing rooms
  • 110 pallet space narcotics vault
Facilities
  • Somerset, NJ, U.S.A.
    • Commercial and development
    • Isolation technologies
      • Milling
      • Roller compacting
      • Granulating
      • Drying
      • API mixing
      • Sieving
      • Tableting
      • Capsule filling
      • Blending
      • Tablet and bead coating
  • Winchester, KY, U.S.A.
    • Category I - II I and solvent-based processing
    • Extrusion and spheronization
    • Commercial high-shear granulation
    • Blending
    • Tablet compression
    • Hardshell-Capsule filling
    • Pan-coating
  • Schorndorf, Germany
    • Category I – IV and solvent-based processing
    • Commercial high-shear granulation
    • Blending
    • Dry granulation
    • Extrusion and spheronization
    • Tablet compression
    • Hardshell-capsule filling
    • Pan-coating

* Xcelodose® is a registered trademark of Capsugel Belgium BVBA