The CPSC gave PharmaDial an F=1 rating, the highest score possible for a pharmaceutical package. Results of testing on how easy the package is for an elderly person to open are due in the next few days, said Jim Hamilton, the company's executive vice president.
In the child safety testing, 50 children aged between 42 and 50 months are asked to open the package. In an initial five minute test, they can use only their hands. Then, after a short break, they are told they can use any means to open the pack, including their teeth.
Colbert first tested PharmaDial in the summer, and found that it passed the first 5-minute test, although a couple of the children were able to access the contents of a blister in the second round. A re-design followed, and in the latest tests the product resisted all the children's attempts.
PharmaDial features a patented three-step process (EZ-3) to allow access to the medication. The user first peels a tab, turns a dial on the pack 90 degrees, and then pushes the tablet through the back of the package. The package is also constructed using Colbert's BlisterGuard paperboard product, which offers a high degree of tear resistance.
Hamilton told In-pharmatechnologist.com that no product using the PharmaDial package is yet on the market, but the CPSC rating means that the company can now step up its detailing efforts. Discussions are already ongoing with a 'handful' of companies interested in using the product, mainly for life-threatening medications, he added.
PharmaDial is not the only packaging of this type on the market, but Colbert believes it is the most accessible. Adding the packaging into an existing production line requires a modest capital outlay but is designed to be a simple, inexpensive process compared to rival systems such as MeadWestvaco's Dose Pack system, which has already been on the market for around 18 months.
Colbert has an alliance with Anderson Packaging, a wholly-owned subsidiary of AmeriSource Bergen, to manufacture PharmaDial and says it can put the product into production very quickly.