Showcase 2002 Discusses Drug Delivery Systems
|Irwin Lerner, retired chairman and CEO of Hoffmann-La Roche, spoke of benefits of unit-of-use packs.|
Innovative drug delivery systems and packaging can help strengthen pharmaceutical sales during a slow economy, despite drug pricing pressures and sluggish research and development pipelines. Presenters shared this view with attendees at Showcase 2002, held September 17–18, 2002, at the Morristown, NJ, headquarters of Honeywell.
The event, also sponsored by PMP News, the Healthcare Compliance Packaging Council (Falls Church, VA), the Institute of Packaging Professionals (Naperville, IL), the PDE Pharmaceutical Trade Association (West Chester, PA), and Drug Delivery Technology, underscored some of the opportunities that lie in drug delivery systems and their packaging.
"Companies have to come up with more products, and they can take their existing portfolios and make them better through drug delivery," said David R. Savello, PhD, senior vice president and chief scientific officer of RP Scherer, a division of Cardinal Health Inc. (Dublin, OH). Savello was one of the event's keynote speakers. He noted that introductions of new drugs are at the lowest point in recent memory; at the time of the event, only 16 new drug applications (NDAs) had been filed in 2002. Factors in the downturn include improvements in drug discovery technology that have enabled more projects with weak potential to be killed before they get to the NDA phase and much of the industry devoting more effort to genomics-based research, which is not expected to pay off for another decade or so. While the downturn in NDAs does not necessarily spell doom for the pharmaceutical industry, it does mean the sector is looking for new ways to make profits in the short term, and providing better delivery systems for existing drugs is a way to accomplish that.
One area with strong potential is pulmonary drug delivery, said another keynote speaker, Ganapati Mauze of Aradigm Corp. (Hayward, CA). The reason, he said, is that pulmonary delivery is precise and efficient for small molecules, because it occurs through the lungs and can get the medication to the heart quickly. It also does not cause the inconvenience and pain associated with injectable delivery systems. One such product, the AERx, he noted, has even taken some of its technology from the blister-packaging arena, as it employs a blister cavity made of Honeywell's Aclar-brand polychlorotrifluoroethylene (PCTFE) where the medication is stored before dispensing.
Better packaging and delivery systems can also be a way for pharmaceutical companies to differentiate their products and establish brand identities with consumers, said Irwin Lerner, retired chairman and CEO of Hoffmann-La Roche Inc. (Nutley, NJ). Direct relationships with consumers are becoming an important key to success in the industry, he noted. In 2000, the 50 most heavily advertised drugs had six times more new prescriptions written than other drugs.
By that token, Lerner said, it might be an advantage for a pharmaceutical company to put its ethical drug in a unit-of-use "patient pack" that provides direct information to the consumer and has graphics that promote the brand, rather than relying on the pharmacist to fill the patient package and provide information on the drug. These efforts could also prevent some of the lost sales the industry suffers as a result of patient noncompliance, he said. However, he noted, it will take a lot of effort to make third-party payers aware of the value of better packaging and delivery systems. Currently they tend to frown on anything that adds cost.
The event's other presentations were from packaging suppliers and others who had insight into technological, market, or regulatory trends in packaging and drug delivery. Following is a sampling of them.
Ed Hancock, president of American Health Packaging (Columbus, OH), the packaging arm of AmerisourceBergen, explained that there are five major considerations in package design: medication function and characteristics, patient medication management behaviors, medication administration settings, manufacturability, and cost. He noted that while cost is often the first of these considered during the design process, it should be the last, after the design team has figured out the best ways to make the package meet the needs of the product and its audience.
David J. Gibboni, PhD, Honeywell's market manager for pharmaceutical flexibles, discussed how film-strip technology could be the wave of the future. He discussed Honeywell's successful collaboration with Pfizer on the Listerine Pocket Pack, a film strip that dissolves on the tongue. It is packaged in Aclar because the substance is so sensitive that it needs very high barrier protection.
Stefan Schmid, marketing manager for Constantia Packaging (Weinburg, Germany), discussed the properties of the "pure Alu" blister, an alternative to trilaminate cold-formed foil. He said that because it is a monomaterial, it is easier to recycle and has no potential for delamination. It is also 7% lighter and has a 35% thinner gauge than traditional cold-formed foils. Another advantage, he said, is that it does not produce pinholes. When there is a breach, it produces a visible crack, and thus there is no need for a sophisticated pinhole detector.