Customizing competitive tablets to your most stringent formulation requirements
As the premier innovator of coated multi-particulate dosage forms, we also offer expert development and manufacturing services for oral solid tablets (as well as powders, pellets, beads, and granules). Backed by a wide range of dose release options - from immediate to modified (including our proprietary Zydis® fast dissolve) - our highly trained scientists can help you develop formulations, then customize hardshell tablets to match specific requirements, thus enhancing your therapeutic outcome. Our experience is vast; we produce over 700,000,000 tablets per year - working with potent APIs, non-chlorinated organic solvents, and all schedules of DEA-controlled substances. As well, our manufacturing expertise - in particular, around fluid bed technology - can help further distinguish your product 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
- Traditional hard tablets
- Bi-layer tablets
- Combines two different APIs into a single tablet, or an immediate-release component with a controlled-release component
Valuable Product Differentiation
- Dose release options
- Immediate Release
- Modified Release
- Delayed Release/Enteric Release
- Repeat Action or Pulse Release
- Proprietary technologies
- Zydis® fast dissolve
- No. 1 selling technology that enhances pre-gastric absorption
How It Works
- Essential tablet characteristics defined and determined during formulation development
- API formulated with excipients to produce powder or granulation for the tablet presses
- Material compressed into tablets on a tablet press
- Tooling of presses varied to create a variety of tablet shapes, sizes, and embossed designs
Catalent Services
Our expert team of scientists can advise you which of our numerous methods is most suited to your tablet production:
- Matrix
- Osmotic pump
- Functionally coating
- Pan layering/coating of tablets
- Extrusion/spheronization/coating
- High drug load
- Fluidized bed layering/coating
Catalent Capabilities
- Tablet presses
- Manesty Express 700 (61 station “B” and 49 station “D” double-sided and bi-layer)
- Manesty Express “B” and “D” tooled
- Korsch PH300 (29 station “D” tooled, single sided)
- Bosch, Index & H&K 1500 capsule fillers all with IMA Precisa 120 weight sorters
- Tablet coaters
- Fully perforated pan-coaters
- Solvent or aqueous
- Available sizes
- 5” to 30” (Somerset)
- 24” to 60” (Winchester)
- 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 & 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