OSDRC®OptiDose™ Drug Delivery Technology (One-Step Dry Coating)
Catalent offers a new option in Drug Delivery to help our pharmaceutical partners bring better treatments to market faster leveraging our deep drug development, delivery and manufacturing expertise and the broadest range of drug delivery solutions.
Catalent is the Drug Delivery partner of choice for controlled release oral delivery and orally disintegrating tablet solutions. With proven in-market success launching over 70 modified release products in all major American, European, and Asian markets, we continue to produce the better dosage-form solutions with superior therapeutic, delivery and release profiles, high quality and efficiency. 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 – get better treatments to market faster.
OSDRC®OptiDose™ is a fully developed technology and has already been commercially proven in Japan for a cardiovascular product. This novel technology is an advancement in controlled release design options and helps significantly improve therapeutic and drug delivery release profiles beyond the capabilities that can be achieved currently. Catalent has recently partnered with Sanwa Kagaku Kenkyusho Co., Ltd to bring this innovative technology to the global market. Catalent will commence customer trials utilizing OSDRC®OptiDose™ in January, 2012 at our Winchester, Kentucky, U.S.A. facility.
Catalent Benefits
- Cutting-edge expertise and proven in-market success over 15 years and +70 products
- 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
Catalent Capabilities
- Development teams in the U.S. and Europe
- Bench, pilot, and full-scale cGMP manufacturing in the US and Europe
- Fully validated and globally approved regulatory manufacturing sites with exemplary records
- Expert management of potent and controlled drugs
- Operational excellence and efficiency via Lean Six Sigma principles
- Full in-house analytical and regulatory services for product development and launch
Optimized Products and Better Treatments:
OSDrC®OptiDose™ technology offers the broadest range controlled release, combination products, and orally disintegrating tablets to optimize dosing, therapeutic and plasma release profiles to meet patient needs in a high quality, one step manufacturing process.
This innovative technology enables the design of single or multi-core tablets, with a practically endless variety of core numbers, shapes, sizes, and placement within the tablet. The flexible-core capability provides new alternatives in controlled release designs for drug formulators, developers, and marketers.
Broad Range of Tablet Options:
- Pulsatile Tablets
- Bi-Layer Tablets
- Combination Products
- Multi-core Tablets
- Dividable Tablets
- Extended Release Tablets
- IR/ER combination Tablets
- Direct Compression Orally Disintegrating Tablets (ODT)
How It Is Made
OSDRC®OptiDose™ includes several technologies, such as variable double punches, that go beyond the parameters of current tableting machines. The very latest technologies developed through a range of simulations have been harnessed to create the ability to manufacture these innovative tablet configurations at a rate of 100,000 per hour, while avoiding such problems as misaligned cores, mass variability, and cross-contamination.
OSDRC®OptiDose™ Technology:
- One-Step Manufacture of Cored Tablets with Variable Double-Punch Technology
- OSDRC® OptiDose™ technology is an innovative new pharmaceutical manufacturing technology that produces precise tablets of nearly any shape using a variable double-punch configuration. This rotary tableting machine has 54 double punches and three feeders. Because the tablets are produced in a single step while the punches make one rotation on a turntable, there is no longer any need for a separate stage to deliver the core. Because the core is held in place by the lower outer punch until immediately before the final compression, misalignment does not occur.
- Various Tablet Configurations Can be Produced Simply by Changing Punches
- The types of tablet configurations that can be manufactured with OSDRC®OptiDose™are unlimited, depending only on the double-punch variations. OSDRC®OptiDose™ technology lets formulators and process engineers freely control the appearance of the tablet and shape of the core, as well as giving them the ability to select the thickness of the coating and precisely control the core's position. This paves the way for completely new types of drug products, such as dividable cored tablets, that were not possible with existing technology.
- Cam Function Provides Precision, High-Speed Tableting
- An innovative cam design is the key to the movement of the double punch system. This cam function allows complex and independent punch movements while maintaining comparable or better productivity than conventional tableting machines
- State-of-the-Art Devices
- The OSDRC®OptiDose™ rotary tableting machine incorporates specifically designed components to prevent cross-contamination of powders. With design elements to collect surface contamination, eliminate powder residue, and recycle excess powder, tableting efficiency of 95% can be achieved. This makes a significant contribution to cost savings.
- Advanced In-Process Control Functions
- The OSDRC®OptiDose™ rotary tableting machine also comes equipped with several highly advanced functions conforming to Good Manufacturing Practice (GMP) standards, including a pressure monitor for each layer, automatic sampling, and an automatic exclusion mechanism.
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
- Project charter
- Project quote
- Signed quote
- Customer PO
- Planning
- Kickoff meeting
- Procurement
- Batch records
- Timeline development
- Execution
- Processing material
- Material Samples
- Testing
- Monitoring and controlling
- Updated charter
- Change control
- Document control updating timeline
- Closing/milestone completion
- Invoices
- Project summary
- Closed meeting
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
- 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 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 four modified release technology facilities have strong track records for both quality and regulatory compliance. We continue to expand and innovate our manufacturing capabilities with the addition of OSDRC®OptiDose™ technology to our Winchester, Kentucky, U.S.A facility.
- Winchester, Kentucky, U.S.A.
- OSDrC®OptiDose™
- Equipment is being installed, and customer pilot trials will commence in January, 2012
- Controlled Release
- High reputation for service and compliance
- Often noted by customers as one of Catalent’s top sites for quality and service
- 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
- Controlled Release
- Notable standards of compliance
- Passed three FDA pre-approval inspections (PAI) and numerous inspections by national and international regulatory authorities
- Services
- Category I-IV 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.
- Zydis® Fast Dissolve orally disintegrating tablets
- Research and development
- Pilot line
- Commercial line with controlled and potent drug capabilities
- FDA audited
- Controlled Release
- Strong compliance
- Passed numerous pre-approval inspections by both U.S. and international regulatory authorities
- Services
- Commercial and development
- Hardshell-capsule filling
- Swindon, U.K.
- Zydis® Fast Dissolve orally disintegrating tablets
- Research and development
- Pilot line with controlled and potent drug capabilities
- FDA and MCA audited
- Controlled drug capabilities
Zydis® is a registered trademark of Catalent Pharma Solutions
OSDrC® is a registered trademark of Sanwa Kagaku Kenkyusho Co., Ltd
Xcelodose® is a registered trademark of Capsugel Belgium
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