Controlling Access while Easing Confusion
In 2009, Key-Pak was used in 547 clinical trials in the United States the and European Union. Introduced by the Keystone Folding Box Co. (Newark, NJ) in 2003, the Key-Pak is a traditional fold-over, heat-sealed blister card that can be customized to fit up to 168 pills in varying sizes and meet a variety of dosing regimens.
In fact, the Key-Paks for all 547 trials were each different. “Of the 547 studies, there were 547 structural designs,” explains Ward Smith, director of marketing. “It is a scalable solution that can be designed to hold just one tablet or capsule or several.”
Key-Pak is manufactured from paperboard with a polyester-laminated layer that controls blister access for senior-friendly child resistance. “Our child-resistant zipper pull tab can be customized to pull away to expose any specific number of pills, which can help guide study patients directed to take multiple pills at one time. Packaging can be used to take away patient confusion.”
The package remains child resistant throughout use because the resistance features do not need to be re-engaged, he adds.
The design can work with PVC, Aclar, or foil blisters as well as heat-seal or pressure-sensitive adhesive.
“We have had zero product failures in the field,” Smith reports.
In addition to a zipper tab, Key-Pak utilizes a two-ply paperboard solution, compared with other standard three-ply and multi-component package designs. “This cost-effective package can help companies meet their corporate sustainable objectives,” explains Smith. In addition, the two-ply system makes for a thin material, helping to streamline assembly and increase throughput.
Printing consistency is also maintained. “Printing required for clinical trials, while minimal, is extremely sensitive to even the most minor color variation in a resupply situation,” Smith says. “Any noticeable variation in color would impact blinding. We control color very well in these situations.”
Compliance packaging plays an important role in clinical trials. “Study subjects in clinical trials are subject to the same type of dosing errors that occur with real-world patients. You can’t lose sight of the fact that study subjects are people recruited from the real world,” says Smith. “Bottles really don’t do a thing to promote compliance/adherence, while a well-designed unit-dose package can help with compliance/adherence.”
Interest in Key-Pak continues to spread. “Recently we have shipped product to India. Inquiries have been recently coming in from Russia, Australia, and Latin American,” Smith reports.