Melt extrusion has been widely utilized in the development and manufacture of pharmaceuticals, including formation of solid molecular dispersions for improved bioavailability of poorly soluble drugs, controlled release dosage forms and implants for local drug delivery. Foster Delivery Science, Inc. offers contract melt extrusion services for the pharmaceutical industry and is a sister company of Foster Corporation, a leader in melt extrusion of biomedical materials for more than 25 years. Tony Listro, Vice President of Foster Delivery Science, talks about the company and their role.
Q: What services does foster delivery science offer?
A: Foster Delivery Science supports clients with melt extrusion services throughout the product life cycle including formulation, analytical characterization, process design and development, process improvement, scale-up, modeling and optimization for clinical and commercial supply. Our twin screw extrusion lines range from 16 mm to 27 mm, offering the ability to produce lab sample formulations to production quantities. We have milling capabilities to produce small (1kg or less) to larger (100s of kgs or greater) quantites. Foster Delivery Science has the capability to extrude films, fibers and monofilames of drug/polymer compositions that can be used for dosage forms for local drug delivery.
Q: How does Melt Extrusion compare to other processing methods such as spray drying?
A: Melt extrusion and spray drying are both widely used to prepare amorphous solid dispersions. The mechanisms are different for both processes. In melt extrusion, mechanical and thermal energy are applied to the materials. Molten drug or drug crystals dissolve in molten polymer or can be suspended in a polymer matrix. Spray drying involves thermal energy applied to atomized droplets of organic solution of drug and polymer. Processing method is found to have profound impact on physicochemical properties and physical stability of amorphous solid dispersions.
In recent studies involving naproxen and povidone polymer blends, we have demonstrated that melt extruded amorphous solid dispersions containing drugs with high crystallization rate are more physically stable than those using the spray drying process.
Q: What is Foster Delivery Science’s unique competitive advantage?
A: Melt extrusion blending of custom formulations is our primary focus. This dedication to the science and application of melt extrusion allows us to offer unparalleled processing knowledge and expertise to our pharmaceutical clients in three key areas: feeding, twin screw extrusion and post extrusion. We have various feeding techniques that accommodate the unique flow characteristics of product inputs. Our team has expertise in screw design and barrel configuration appropriate for melt blending active ingredients and we tailor the process setup for each formulation to control critical process parameters. Post processing is critical to control the cooling rate of the product extrudate and controlling dimension of shaped product. Our range of processing equipment along with a comprehensive lab allows our technical team to produce products with optimal results.
Q: What are your plans for investment and growth?
A: Foster Delivery Science recently commissioned a new 32,000-square foot, cGMP facility, dedicated to the development and manufacturing of melt extrusion formulations for the pharmaceutical industry. The company continues to invest in process and laboratory equipment. We are in the process of qualifying our D6A Fitzmill for large scale cryo-milling of polymers and milling of drug-polymer formulations. This year we’ve invested in our lab by adding new Karl-Fischer moisture analysis equipment, purchasing a new UPLC along with several other investments.
For more information, please visit Foster Delivery Science at AAPS 2018 in Booth #1808.