EXPANDING THE RANGE OF POSSIBILITIES SOFTGELS
As the inventor of the rotary die encapsulation process still used today in modern softgel manufacturing, Catalent continues to lead the industry with cutting-edge drug delivery innovations. Our award-winning OptiShell® technology platform further advances drug delivery in softgel by providing development solutions for challenging compounds contained within complex fill formulations.
OptiShell® capsules utilize a patented shell derived from plant polysaccharides that are ideally suited for the encapsulation of higher melting point fill formulations. Softgels containing semi-solid matrices for modified release of poorly soluble and/or poorly permeable drug compounds are now an option, and only Catalent has succeeded in achieving FDA approval for such a formulation. For immediate release applications, OptiShell® technology expands the range of compatible fill formulations and excipients available for developing lipid-based capsule formulations, providing more solutions for solving unique drug delivery challenges.
The combined strength of OptiShell® technology and Catalent RP Scherer Softgels enable encapsulation of broader range of lipid-based formulations.
- Improves bioavailability for a greater number of poorly water-soluble and poorly permeable compounds
- Modified or extended release of compounds delivered in consumer preferred softgels
- Solves complex development and formulation challenges beyond conventional softgel technology
- Patented shell composition can handle:
- Encapsulation of high temperature fill formulations (up to 70˚C) for semi-solid and highly viscous fill formulations
- Higher pH fill formulations
- A wider range of compatible fill excipients for enhancing drug bioavailability and stability
VALUABLE PRODUCT DIFFERENTIATION
- Proprietary technology and process with strong IP protection
- Better patient adherence – easy to swallow
- Gelatin-free products for expanded markets
- Elimination of potential shell odor and a non-distinguishing taste
We have a long track record of customizing successful programs involving our proprietary advanced technologies:
- Pre-formulation and feasibility studies
- Solubility screening of New Chemical Entities
- Softgel capsule fill formulation development
- Small-scale lab encapsulation for early stability data and final formulation selection
- Shell development
- Strong IP (intellectual property) positions including fill formulations for improved bioavailability
- Extensive technical support in softgel capsule product development
- Reliable supply from clinical phases to commercial manufacturing
- Contingency planning and quality assurance via our expansive global network
Our deep formulation expertise supported by a global infrastructure of cGMP, FDA, EMA and locally accredited softgel facilities will provide a catalyst to your success by tailoring a unique drug delivery solution to bring your product faster to market.