The expanding possibilities of soft capsules.
Catalent invented the rotary die encapsulation machine widely used in soft capsule manufacturing. Since then, it has continued to lead the industry with cutting-edge drug delivery system (DDS) technology. The "OptiShell," developed in this process, is an award-winning technology that enables complex formulations of difficult-to-develop compounds, evolving drug delivery in soft capsules. OptiShell is ideal for encapsulating high-melting-point contents due to its patented coating derived from plant-based polysaccharides. Soft capsules filled with semi-solid matrices allow for the controlled release of poorly soluble or low membrane-permeable compounds, making Catalent the only company to successfully obtain FDA approval with this formulation. Additionally, in the development of immediate-release formulations, it expands the options for contents and excipients available for lipid-based capsules, addressing challenges in drug delivery. By combining the strengths of plant-based soft capsule OptiShell with other capsule technologies, the range of lipid-based capsule formulations is broadened.
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basic information
■Improving the bioavailability of many compounds that are poorly water-soluble or have low membrane permeability ■Providing controlled-release formulations and sustained-release formulations in soft capsules preferred by patients ■Solving complex development and formulation challenges that were difficult with conventional soft capsule technology ■A patented coating achieves the following: ・High-temperature filling (up to 70°C) for semi-solid, high-viscosity formulations ・Filling of higher pH contents ・Improvement of bioavailability and stability through an expanded choice of excipients ■Unique technology and processes protected by intellectual property rights ■Easy to swallow, contributing to improved medication adherence for patients ■Free from animal-derived materials (gelatin), also aiding market expansion ■Resolving issues related to the odor and peculiar taste of coatings
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Applications/Examples of results
The following excellent technologies have successfully customized various development programs: ■ Preliminary formulation and feasibility studies ■ Solubility screening of new compounds ■ Development of filling solutions for soft capsules ■ Small-scale lab-level capsule filling for initial stability data acquisition and final formulation selection ■ Coating development ■ Strict intellectual property protection, including filling solution formulations for improving bioavailability ■ Extensive technical support in the formulation development of soft capsules ■ Stable supply from clinical trial stages to commercial production ■ Business continuity planning and quality assurance through a vast global network
Company information
Our company is a global enterprise that provides advanced and excellent development and manufacturing technologies in the fields of oral pharmaceuticals, biopharmaceuticals, and consumer health. As an innovator in formulation development and manufacturing, we propose better treatment and health-appropriate solutions, and we support the stable delivery of high-quality products that are highly reliable.
