Oral Macromolecule Delivery
ENABLING IV TO ORAL CONVERSION OF MACROMOLECULES
Currently, due to permeability, stability, and delivery challenges, the dosing of macromolecules has been traditionally delivered in an intravenous form. Intravenous drug delivery, while able to provide an optimal pharmacokinetic therapeutic profile, presents challenges such as ease of use, dosing frequency, regulatory challenges, costs, and compliance.
Catalent OptiGel® Bio technology incorporates a proprietary technology that may overcome the traditional hurdles by enhancing permeability and enabling a targeted delivery through enteric coating. Catalent’s development expertise can rapidly identify an optimal Oral formulation enabling the traditional benefits of an oral softgel formulation and subsequent commercialization.
OPTIGEL® BIO BENEFITS
- Improves permeability of high molecular weight, rigid molecules.
- Prevents gastric degradation to ensure active API is maintained.
- Targeted delivery through enteric coating.
- Enables the conversion of IV therapy to a more convenient, easier to administer dose form.
- Flexibility in dosing to achieve desired therapeutic profile.
VALUABLE PRODUCT DIFFERENTIATION
- Proprietary technology and process.
- Improved patient adherence – fewer physician visits, less painful administration.
- Customization of therapeutic profiles.
We have a long track record of customizing successful programs involving our proprietary advanced technologies:
- Pre-formulation and feasibility studies.
- Permeability screening of macromolecules.
- Softgel capsule fill formulation development.
- Small-scale lab encapsulation for early stability data and final formulation selection.
- Capsule 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 large global network.
Our deep formulation expertise supported by a global infrastructure of FDA, EMA and locally accredited cGMP softgel facilities will provide a catalyst to your success by tailoring a unique drug delivery solution to bring your product faster to market.