When your product is ready for clinical trials, we are ready to support you with scale up and current Good Manufacturing Practices (cGMP) clinical trial manufacturing. Foster Delivery Science has the equipment, facilities, personnel with over 100 years of experience to support cGMP clinical studies. Our cGMP suites and equipment are qualified and documented to meet industry quality standards. The Foster Delivery Science team has manufactured clinical trial materials for preclinical studies, Phase I, Phase II and Phase III.
Formulation development is generally performed using small, laboratory equipment. Scale up of these formulations is always a challenge in pharmaceutical industry.
When scaling a formulation, our first step is to match process energies between the extruders, both mechanical and thermal. Mechanical energy influences the degree of mixing achieved in the process and thermal energy determines the amount of heat the formulation experiences in the process. Our use of computer aided process simulation software allows us to match energies between the small and large extruders. This requires thermodynamic and rheological characterization of the formulation. The simulation provides an initial screw design and process conditions.
Once initial design and process conditions are established, we perform extrusion trials to compare to the original samples to the scaled samples. Iterative trials to fine tune process conditions may be required to achieve the desired results.
Foster Delivery Science provides manufacturing services in accordance with FDA cGMP. Our cGMP systems assure proper design, monitoring, and control of manufacturing processes and facilities. From quality management systems, raw material handling procedures, operating procedures, deviation detection and investigation protocols and laboratory testing maintenance, we meet regulatory standards in order to provide the highest quality product.
- Turbula Mixer
- Bohle Bin Blenders
- High Speed Mixer
Foster Delivery Science utilizes Loss in Weight Feeder technology (LIW), specifically designed to accurately dispense materials, including powders, liquids or pellets.
- Single LIW
- Twin LIW
- Liquid LIW
Our extruders can be configured for a variety of processing approaches including coextrusion. Twin screw extruders are frequently used to prepare solid dispersions due to their distributive and dispersive capacities, and short transit time. Screw elements, screw rotation and screw speeds can be custom tailored for each formulation. Single screw extruders are used to meet and control tight dimensional tolerances when directly extruding shapes.
- 18 mm twin screw (2)
- 27 mm twin screw
- ½” single screw
- ¾” single screw
Foster Delivery Science uses melt extrusion processing to manufacture a variety of most dosage forms, including:
- Powders, granules and pellets
- Films (buccal, transdermal)
- Customized Dosage Forms