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Pfizer's inhalable insulin a first for diabetics

By mid-year, a multicomponent inhaler containing Pfizer's Exubera insulin powder will offer diabetics the first inhaled form of the drug, eliminating the need for an injection. 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 2,500 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 in the 1920s."

The mechanical Exubera device has three subassemblies: 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.

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 in Europe.

The Tech Group manufactures and assembles the complete device, shipping them to Pfizer for final packaging and placement into kits. At its new production facility in Terre Haute, IN, Pfizer reportedly uses thermoform/fill/seal equipment to do the job.

--By Jim Butschli, Editor
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