Foster’s dedicated business unit for highly regulated materials, Delivery Science, specializes in blending polymers and active pharmaceutical ingredients with twin screw extrusion technology in a cGMP clean room environment. Traditionally the company provided custom blends in pellet form for conversion into shapes used for drug delivery. These shapes included film for mucosal and transdermal patches, and rods for implantable drug delivery. Foster now also offers a range of custom film and rod extrusions for these applications.
Foster’s unique approach combines material blending with the direct extrusion shape forming process, which provides a significant advantage for polymers with active pharmaceutical ingredients. “Many active pharmaceutical ingredients are temperature sensitive. Heat histories associated with multiple processes that risk degradation of the drug can severely limit a particular delivery platform,” said Tony Listro, Delivery Science Managing Director. “Direct extrusion removes a heat history associated with independent processing of film or rod for pre-compounded pellets, reducing the risk of degradation to the drug. Performing the entire process in a single cGMP controlled facility consolidates supply and regulatory logistics.”
At the present time Delivery Science can produce drug/polymer film in widths of 2 to 5.5 inches (50.8 – 139.7 mm) and thicknesses of 0.0012 to 0.0394 inches (0.03 - 1.00 mm) and solid rods ranging from 0.020 to 0.315 inches (0.508 - 8.0 mm).