The U.S. Food and Drug Administration approved Exubera for adults with both Type 1 and Type 2 diabetes January 27, a day after the European Commission approved the product for use in the European Union. Exubera’s efficacy and safety was studied in more than 2귔 adults (including both diabetes types) for an average of 20 months.
A Feb. 7 article at www.fdanews.com described Exubera as “the first new insulin delivery option introduced since the discovery of insulin the1920s. Currently, more than five million Americans take insulin injections to control diabetes.”
The mechanical Exubera device has three sub-assemblies: a base assembly with a mechanical pump; a chamber; and an insulin-release unit. The components are made of a variety of injection-molded plastic materials, including polycarbonate, acrylonitrile-butadiene-styrene, nylon, and styrene acrylonitrile. To see how the device works, visit www.runsweet.com.
Nektar Therapeutics created the foil blister pack for the purpose of storing and administering the powdered drug, keeping it protected and moisture-free for up to two years. Nektar developed the method to create a powder from the liquid insulin, as well as the delivery device, licensing the technology to New York-based Pfizer, according to contract manufacturer The Tech Group, West Pharmaceuticals. The Tech Group built two sets of tooling for the injection molds used to make the Exubera inhaler components, one for its own production of the inhaler, another for Bespak plc in Europe.
The Tech Group manufactures and assembles the complete device, shipping them to Pfizer for final packaging and placement into kits. At its Terre Haute, IN, plant Pfizer reportedly uses thermoform/fill/seal equipment to do the job.
In a press release announcing the FDA’s approval of Exubera, Pfizer notes that it has invested in two state-of-the-art manufacturing facilities to produce the drug, one in Frankfurt, Germany, the other “a highly automated, high-tech production facility in Terre Haute, IN.”
“Exubera is a major, first-of-its-kind medical breakthrough that marks another critical step forward in the treatment of diabetes,” says Hank McKinnell, Pfizer’s chairman and CEO. —Jim Butschli
