Clinical Trial Materials
Capsugel Dosage Form Solutions offers a full range of CTM (Clinical Trial Materials) manufacturing, packaging and logistics services. We provide an integrated product development approach supporting all aspects of drug design, development and clinical supply solutions for phase I-V. Our “speed-to-product” approval capabilities include preformulation, formulation development, analytical services, cGMP manufacturing for both clinical and commercial scale, as well as global clinical supplies packaging and logistics.
Capsugel’s formulation range includes all aspects of solid oral dosage form development:
- Tablets – Immediate release, modified or sustained release, bi-and tri-layered, mini-tabs, chewables, and orally dissolving
- Encapsulation – Powder and multiparticulates, enTRinsic™ drug delivery technology, capsule-in-capsule technology
- Multiparticulates – Lipid multiparticulates, mini-tabs, extruded / spheronized, fluid bed coated
- Lipid / liquid and semi-solid filled – Liquid fill hard capsules, soft gels, lipid multiparticulates
- Fixed dose combinations – Drug layered / fluid bed coated multiparticulates, bi- and tri-layered tablets, capsule-in-capsule technology
- Coating of tablets, capsules and multiparticulates using pan coaters or fluid bed processing
Capsugel specializes in innovative product design tailored to meet specific target product profiles and commercial objectives. Formulation “manufacturability” and scalability are factored into the earliest phases of drug development Quality by Design (QBD) principles. Phase-appropriate equipment – much of which is proprietary – is utilized for Phase I-IV cGMP clinical and small-scale commercial manufacturing.