Implants and Drug Delivery
Implantable polymers and drug delivery polymers are custom formulated in a dedicated, highly regulated environment using precision hot melt extrusion blending and forming technologies. Within this business unit, known as Delivery Science, we frequently add active pharmaceutical ingredients to the polymers for combination products and oral dose pharmaceutical applications. Our Delivery Science team offers formulation, feasibility, process development, scale up and manufacturing services in a cGMP clean room environment.
Our experience includes process Design of Experiment (D.O.E.), validation batches, supplies for human clinical trials Phase I, II, and III) and samples under cGMP conditions for bioequivalency studies.
- API Formulation – Polymer Selection
- Feasibility - Small Batch Production
- Process Development - Non-GMP Process Definition
- GMP Trials – Clinical Supply
- Scale-Up - Maximization of Throughput
- Validation - Process & Test Methods
- Production – Implement Manufacturing Protocols
Pharmaceutical hot melt extrusion for implantable and oral dose delivery is performed in a cGMP clean room production facility using twin screw extruders that incorporate cGMP design for medical and pharmaceutical applications. Twin screw extruders have several advantages such as easy material feeding, high kneading and dispersing capacities, and short transit time. Screw elements, screw rotation and screw speeds can be custom designed for the formulation being produced.