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It's no secret that innovative, easy-to-use drug delivery systems are leading the charge these days in the pharmaceutical and medical markets. Just take a look at the most recent study by The Freedonia Group Inc. (Cleveland), "High Visibility Packaging to 2008." That report, published earlier this year, predicted that the fastest growth will come from prefillable syringes as well as products that combine a medical device with a pharmaceutical formulation. In addition, the study reported that both disposable and single-use medical devices will also fuel future growth.

The latest example of this fast-moving trend is a new FDA-approved growth hormone delivery system from Novo Nordisk, the Denmark-based drug-delivery pioneer. This new prefilled, multidose delivery system, called the Norditropin NordiFlex, uses the same penlike design as the company's NordiPen insulin-delivery system. Its cartridges contain a growth hormone indicated for the long-term treatment of children who have growth failure due to inadequate secretion of endogenous growth hormone.

The product also illustrates how new technology is simplifying drug delivery for patients. Since the product is prefilled and contains multiple doses, no loading of cartridges is required. It also features a dial-back reset option. The overall ease of use allows for easier training of the healthcare professional and the patient. According to Michael Shalmi, MD, Novo Nordisk's vice president of biopharmaceuticals, "This product eliminates the need for reconstitution and the complex loading of devices."

The system is available in a 5 mg/1.5 ml pen that delivers doses from 0.025 to 1.50 mg. It also comes in a 15 mg/1.5 ml pen that delivers doses from 0.075 to 4.5 mg. A total of 100 different dosing options are available with the two systems.

While the Novo Nordisk is an exciting development, it also serves as a reminder that the growth of combination devices may require some companies to rethink their packaging operations. Packaging such a combination drug/device may mean a medical company will need to more deeply familiarize itself with pharmaceutical regulations. For example, sterilization issues are but one challenge facing packagers of products that contain fragile drugs with live cells or proteins. Perhaps new sterilization methods or new applications should be considered.

Fortunately, educational opportunities abound for those companies that are interested in this market. One promising opportunity is an upcoming meeting presented by Pharmaceutical Education Associates. The conference, "Profit from the Growing Self-Injectables Market with Innovative Planning and Design Strategies," takes place November 15-16 at the Loews Hotel in Philadelphia. Attendees at this conference will be able to learn about regulatory viewpoints on prefilled syringes, assess the risks and benefits of self-injectable safety, and gain valuable knowledge on the market as a whole. It promises to be a good chance for packagers and others to get a firsthand look at what continues to be the new face of market growth.

Ben Van Houten

Pharmaceutical & Medical Packaging News
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