With the goal of becoming the safest, most portable and user-friendly auto-injector on the market, an innovative epinephrine auto-injector in development for patients at risk for anaphylaxis, or severe allergic reaction, is utilizing Bayer MaterialScience LLC plastics. It combines a well-known medicine with a customized delivery system, resulting in a unique solution for patients.
Intelliject Inc., a specialty pharmaceutical company, created the product, which has recently been granted tentative approval by the United States Food and Drug Administration (FDA) as e-cue. The need for a product that empowers people to be in control of their medical conditions hits close to home for the founders of Intelliject – identical twin brothers who, themselves, have severe food allergies.
The Intelliject auto-injector, the size of a credit card and thinner than a typical cell phone, is being developed to be carried by at-risk individuals at all times. In the event of a severe allergic reaction, a patient would remove it from its outer case, activating the device’s voice-guided PromptSystem that walks the person through how to use the product.
Several parts of the device are molded from Bayer plastics.
The outer cover of the device needed to be very thin, according to Mark Licata, vice president, industrialization and quality, Intelliject Inc. “Makrolon 2458 medical grade polycarbonate is the ideal material for molding the thin walls of this part because it is a high-flow resin,” Licata states.
The electrical cover, white housing and top and the red safety guard of the device are injection molded using two medical grades of Bayblend polycarbonate/acrylonitrile butadiene styrene (PC/ABS) blend plastic, Bayblend M850 and Bayblend M850XF. Additionally, the piece of the device that touches the patient during injection is molded from Bayblend M850XF. The medical grades of Bayblend PC/ABS blend plastic meet the requirements of the FDA-modified ISO 10993-1 tests for biocompatibility while offering impact resistance and rigidity, as well as dimensional and color stability.
"As someone who has suffered severe allergic reactions myself, I know it is critical to have an epinephrine auto-injector that can be taken anywhere and that can cope with rough and tumble situations and still perform,” says Evan Edwards, co-founder and vice president of product development, Intellijec, Inc. “People often talk about a product as ‘tough enough to be run over by a car’ as a figure of speech, but we set that as our standard for the e-cue. When we received the first batch of devices we took one outside and drove back and forth over it with a car. It was undamaged, which speaks volumes about both its design and the constituent materials.”
“The design of the Intelliject auto-injector is what we believe will make it unique in the market,” Edwards continues. “Bayer’s engineered plastics made it possible to achieve a novel, patient-centric design. But beyond supplying its materials, the Bayer team also provided technical support throughout the device’s development, conducting finite element analysis and mold-flow analysis of the materials, which was a great help in the process.”
“We worked with Intelliject for several years to advance this device,” says Bruce Fine, market segment leader, Medical and Consumer Products - Polycarbonates, Bayer MaterialScience LLC. “We were able to offer the most appropriate medical-grade and general-purpose plastics that met the requirements of several components. We are glad that we were able to provide the materials and technical support that played a role in the design and continued development of this innovative product.”
e-cue was granted tentative approval by the FDA in August 2011. Tentative approval means that the product review is complete and the submission met the FDA’s requirements to be approved. The FDA reserves final approval of the product, however, until all exclusivity or patent challenges have been resolved.