OptiDose™ Drug Delivery Technology
Flexible single or multi-cored tablets
OptiDose™ is an innovative flexible core tableting technology that enables the formulation and manufacturing of single or multi-cored tablets with differentiated controlled release functionality and a range of unique dose forms including fixed dose combination tablets.
OptiDose™ (one step dry coating) tableting process simplifies manufacturing by forming the tablet and core in a solvent free, dry compression single process operation. The innovative variable double punch and independent cam movement provide the flexibility to produce cores of various shapes, sizes and positions within a tablet.
OptiDose™ is a fully developed technology and is commercially proven in Japan for cardiovascular and type II diabetes products. Catalent has exclusively partnered with Sanwa Kagaku Kenkyusho Co., Ltd to bring this innovative technology to the global market.
OptiDose™ Technology enables our pharmaceutical and OTC partners to formulate, development, manufacture, and ultimately bring better treatments to market.
- Better drug efficacy and safety
- Optimized pharmacokinetic and pharmacodynamic profiles to deliver more drug when it’s needed
- Targeted drug delivery to deliver more drug where it’s needed
- Improved disease management
- Better compliance/reduced pill burden
- Enhanced patient convenience
- Enhanced product branding and differentiation
- Tablets with a unique look and feel
- OTC or Private Label product orientation
- Potential anti-counterfeit protection
Broad, Innovative, Differentiated Tablet Forms:
OptiDose™ single and multi-core tablets pave the way for new options in tablet formulations.
- Flexible single or multi-cored tablets
- Multiple discrete cores in an individual tablet
- Flexible core shapes, sizes, and positioning within tablets
- Dividable tablets with discrete cores
- Address FDA 2013 new guidelines for dividable tablets
- IR, CR and enteric coated tablets
- Loosely or poorly compressible encased
- Alternative to encapsulation
- Precision thin layer coating
- Alternative to film coating
- Wide variety of tablet shapes and sizes
- Round or oblong
- With or without debossing capabilities
Advanced Controlled Release Formulations:
- Full range of Controlled Release formulations
- Pulsatile release
- Enteric coating for targeted delivery
- Delayed release
- Extended release (XR, SR)
- Multi-release profiles: Immediate/Extended/Enteric/Delayed
- Fixed Dose Combination formulations
- Combination release profiles for up to 3 API’s in a single tablet
Innovative Technology – How it Works:
The patented, variable, double punch configuration and cam function allows for complex and independent movement of inner and outer, upper and lower punches. This enables formulation and manufacturing of tablets across the range of OptiDose™ combination and controlled release dosage forms.
Different single or multi-core tablet configurations are produced by changing the punches of the rotary tablet machine.
- Punches can be customized to meet your desired tablet configurations
- Enabling flexibility in core shapes, sizes, and positioning multiple active cores within a tablet
- Tablets and Cores are produced in a single, solvent-free one step dry coating process operation
- Simplifying manufacturing by eliminating the need for a separate unit operation to produce the core, and the need for solvent handling.
- Independently moving variable double punch design facilitates the manufacture of precision quality tablets
- Superb weight control of layer quantities
- The tablets and cores are produced in a single stage while the punches make one rotation on the turntable, producing precise coatings of nearly any thickness and tablet shape utilizing the innovative cam movement design and variable double punch configuration.
- Highly accurate core alignment
- Cores are held in place by the lower outer punch until immediately before the final compression, ensuring core alignment.
- Minimized cross interaction between API core layers and/or coating excipients
- The tablet construct reduces surface area contact vs. conventional tablets, increasing stability for non-compatible API’s for combination tablet formulations.
OptiDose™ Technology is located at our Somerset, New Jersey, U.S.A. advanced delivery technology center.
OptiDose™ is a trademark of Catalent Pharma Solutions