Investing in the Wallet

Do wallet-style blister packages pay real dividends when it comes to patient compliance?

Daphne Allen, Editor

 

RxBarrier wallet cards courtesy Cardinal Health

There is no simple or universal definition of a wallet-style blister package. Perhaps it could be defined as a blister package provided in paperboard that folds like a wallet. Some, however, fold in and out of cartons, and others may be encased in plastic. Some may look more like booklets than wallets. And some couldn’t even come close to fitting in a pocket like a wallet.

Regardless of their form, they usually feature other elements that offer literature, calendars, or other dosing reminders. Many styles offer unique child-resistant and senior-friendly features. Branding and anticounterfeiting are options, too.

“Predominantly, wallet-style blister packages are used to enhance patient compliance via written instruction and physical display formatting,” says John G. Steenkamer, market development manager, pharmaceutical, for Klöckner Pentaplast of America (Gordonsville, VA).

“The standard blister in a box is the simplest form of compliance packaging,” adds Daryl Madeira, manager, compliance packaging, for MeadWestvaco Healthcare Packaging (New York City). “But if you are looking to elevate compliance, to better balance child resistance and senior friendliness, and to have more billboard space, consider the wallet,” he says.

Three wallet-style packages were honored in the Healthcare Compliance Packaging Council’s latest Compliance Package of the Year program. The top award, the Compliance Package of the Year for 2004, was the Warfarin Track Pack from Taro Pharmaceuticals, which was engineered and developed by American Health Packaging (Columbus, OH). First runner-up was the Namenda Patient Starter Kit by Forest Pharmaceuticals, which was a box wallet package designed by Dividella Pharma Packaging Technology, part of the Körber Medipak Group. The second runner-up was the Imitrex nine-count by GlaxoSmithKline, packaged in a Perfpak from MeadWestvaco.

One of the industry’s best-known wallet packages is the Z-Pak for Zithromax. The multiple-panel package presents a short course of antibiotic therapy with information to encourage compliance.

BANKING ON BENEFITS

If a drug product is already in a blister, it is a good candidate for a wallet-style package, says Helmut Deichert, worldwide product manager for Bosch Packaging Technology (Minneapolis, and Waiblingen, Germany).

“The beauty of a wallet is that the blister provides the primary protection, so new stability testing would not be required,” adds Bill Eveleth, vice president of sales and marketing for TestPak (Whippany, NJ). “A wallet can be added easily.”

Wallets can also extend one package design from one market into another, says Eveleth. “It gets very interesting. We helped one customer earlier this year extend an OTC product into the hospital unit-dose product market.”

Marketing benefits abound. Bill Sharpless, market director for pharmaceutical and medical packaging for Alcoa Flexible Packaging (Richmond, VA), says that “the wallet-style package also offers marketing and brand managers the tool they have been searching for to increase communication with the patient.”
Additionally, wallet packaging can be a weapon against counterfeiting. “Covert and overt features are easily placed into a wallet-style package, and tamper evidence is superior to that of traditional bottle packaging,” says Sharpless.

Deichert says that some drug companies consider wallets for their blister packages precisely to add child resistance to the packages. Bosch designs automatic cartoning systems for traditional wallets as well as the Pharma SHR (small-hands-resistant) package designed by Stora Enso Packaging Boards. The package requires two hands to push, hold, and pull certain mechanisms in order to open it, but only slight muscular power, for senior-friendly child resistance. In tests conducted according to Consumer Product Safety Commission (CPSC) regulations, the package has demonstrated an F-1 child-resistance rating. It is made with specially developed CKB Pharma TR board, which has high tear resistance.

Yves Massicotte, president of Ropack (Montreal), says that wallets can be designed according to the level of child resistance needed. “We can use stronger paperboards and use special die-cuts on the inner and outer cards,” he says. For high levels of child resistance, he says, child-resistant paper/foil lidding constructions could be used in addition to the wallet-package features. The contract packager has been working with Intini Marketing for two years to offer a bifold wallet-style blister with pockets for patient package inserts called the Bend and Peel Blister Pack.

TestPak has recently expanded its FamilyPak range of solutions for child-resistant and senior-friendly packaging. “We have launched or have in development several novel platforms for carded and reclosable systems. We also have some novel designs we are developing with locking features to prevent separation of the blister and the outer sleeve,” says Eveleth. “This is a challenging category because you’re trying to achieve difficulty of use and ease of use at the same time, not to mention at an affordable cost. We do not believe that balance has been fully realized yet. We expect to announce new offerings in 2006.”

The Packaging Services business of Cardinal Health (Philadelphia) offers the RxBarrier wallet card, which can be customized for use with any type of thermoformed or cold-formed push-through blister, explains Victor Gherdan, packaging engineer supervisor. “The plastic barrier cover acts as a shield to protect the product cavities from biting, tearing, or other damaging forces, and it introduces rigidity into the package. It creates an added layer in the perimeter of the card that also increases the tear resistance of the package.” The package has obtained the CR rating of F-1 on several occasions, he reports. It also has obtained “nearly perfect adult-use effectiveness scores,” he says. “Most people are familiar with simple push-through opening features requiring only direct pressure to be applied in line with the product cavity. The force required to remove the product can be controlled by changing the shield geometry, materials, and cut features on the back of the card.” A second-generation shielded package is also in the pipeline, along with a peelable version.

Material Needs

For wallet-style and other blisters, Alcoa offers its Tough Pouch foil/film structure. “For child resistance, it uses a cross-lamination film process combined with foil for high MVTR protection,” says Sharpless. “For medications designed to use specialized delivery systems and demonstrating hygroscopic properties, our structure provides high burst strength, tear resistance, and printability, as well as proven child resistance.”

Chris Hession, project engineer, product development, for MeadWestvaco, says that SBS board is typically used for wallets, as clay-coated TS is used, both with hot-melt adhesives or heat-seal coatings. The company also offers EasySeal extrusion-coated heat-seal paperboard as well as EasySeal Plus, which seals to a wider variety of films and foils, including PVC, PVdC, PET, and polystyrene. According to MeadWestvaco, it is the only paperboard that seals consistently to Honeywell’s Aclar.

Todd Swartz, commercial engineer for INEOS Films, Pharma Business (Delaware City, DE) and formerly a packaging engineer with Perrigo, says he sees a lot of creativity in child-resistant wallet packages, but he also sees a lot of performance variability. “Most concepts rely on paperboard, but it doesn’t always function consistently. If it is old, or is exposed to moisture or high humidity, it won’t always work as intended,” he says.

Instead, Swartz looks hopefully to systems that rely on plastics, like MeadWestvaco’s Shellpak. “Their approach is to standardize the compliance package so that the blister itself is not part of the child-resistance mechanism,” he says. Some child-resistant blister lidding combinations are not user-friendly, he adds, and “compliance packaging needs to be user-friendly.”

Drug manufacturers need to be careful when looking to something other than the blister for child resistance. CPSC requires that primary packaging provide child resistance, not secondary packaging. However, even though MeadWestvaco’s Shellpak relies on the plastic outer carton to provide child resistance and not necessarily the blister inside, a plastic hook inside Shellpak prevents the blister from being fully removed, so Shellpak is listed as an ASTM Type XIIIA Press Hold, Pull Out (Parts Remain Together), Push Out package under the ASTM Type XIII Reclosable Packaging, Semirigid Blister category. Other wallets are available to provide child resistance, like the TopPak from Dividella/Rondo AG, listed as an ASTM Type XIIIE package, Press Then Flex And Lift To Open package. The key to CPSC compliance may be whether the primary package can be removed from the child-resistant mechanism.

Table I. The wallet-style package is a multipanel carded blister that contains the product and the provision of critical information in an easy-to-use package. The package style provides several key features and benefits. Source: Carl Hart, account executive, Sharp Corp. (Allentown, PA).
(click image to enlarge)

In paper-based systems, another issue that must be considered is how the paper is being sealed together. Richard Bahr, president and CEO of MGS Machine Corp. (Maple Grove, MN), which manufactures wallet and sealed folded card equipment, describes the MGS process equipment for wallet assembly: “Typically, a two- or three-panel folded card captures a blister between two card panels sealed with a small amount of adhesive. The sealed area is a small percentage of the total and is therefore probably not child resistant.”

When child resistance is required, MGS employs what Bahr calls the sealed folded card approach: “This package may look and feel much like the wallet, but it has a higher percentage of sealed area and can be used where child resistance is required. Two sealing formats are currently being used: coated card stock can be heat activated after blister insertion with folding as a separate operation, or a hot-melt adhesive can be applied.” MGS also supports the automated assembly of MeadWestvaco’s Dosepak. “It is the same format as a sealed folded card, but is then folded and inserted into a specialty carton. This product has a child-resistant opening to the carton, and child resistance can be built into the card itself.”

WATCHING THE POCKETBOOK

Steenkamer of Klöckner Pentaplast says that wallet-style packages require integrated machine processes that can be very demanding of the packaging materials. “As such, materials should be evaluated on their ability to minimize value-added scrap and downtime related to jams, etc. Within a wallet construction, sealing between layers of SBS and blister cards can be challenging based on varying surface properties of polymer type or coating.”

He explains that specialty forming webs may be used to improve operating windows. For instance, “Klöckner Pentaplast’s Pentapharm Aclar S03 and Pentapharm COC products with symmetrical contact substrate and sandwiched moisture-barrier property provide improved lay-flat that can be critical in wallet-style blister formats. With spillage potential, blister lay-flat can be critical during long transfer routes between product feeding and sealing stations, in addition to when ejection speed of blisters from the storage magazine is desirable.”

Flat formed and sealed blisters are key to creating a quality compliance card, says Swartz. “Curled blisters do not enable packages like Shellpak to function properly. Curled blisters also can impact paperboard card assembly. Automated and manual pick-and-place equipment will not function properly. In some cases, paperboard thickness may need to be increased to overcome curl.” To avoid curl, he says that INEOS Films’ PVC formulations were developed with wide temperature processing windows. These include the firm’s PVC monofilms, duplex PVdC films, and Alcar laminations.

Equipment selection and line operation vary depending on the design of the blister foil unit and how it is adhered to the card or wallet as well as whether the line will be automated or involve hand assembly, says Sandy Luciano, marketing manager for contract packager Sharp Corp. (Allentown, PA). “These issues are discussed at the onset of a project with engineering. For example, if a customer provided a stand-alone blister card and wanted to place it into a wallet, there are many ways to accomplish this, either via automation or hand fed systems. The wallet might use a hot-melt system or adhesive to adhere to the blister. Depending on the base film of the blister, a special adhesive may be required for the card stock. Ideally, for the customer, it is best if the base film of the blister does not change.”

Automating Wallet Assembly

The Dividella NeoWallet 800 line.

The Packaging Services business of Cardinal Health (Philadelphia) produces a number of wallet-style blister packages according to customer needs, and the contract packager has even devised its own designs, Slide Pack and RxBarrier. (Slide Pack was recently used in a regimen-compliance study by Ohio State University. Use of the package did appear to improve patient compliance with a blood pressure medication, leading to lower blood pressure.)

For years, Cardinal Health relied upon manual wallet assembly, using heat-seal equipment and heavy labor, says Louis Weiner, director of engineering. Given the multiple steps in wallet production, “almost everything required hand assembly,” he says. Such equipment was sufficient, but the process required a lot of adjustments, subjecting the operation to routine downtime.

Weiner decided to investigate automated walleting systems, and Cardinal Health settled upon the Dividella NeoWallet 800 line, provided by Körber Medipak N.A. Inc. (Clearwater, FL).

The Dividella NeoWallet 800 is designed to produce a variety of wallet packages, from single-panel wallet cards to more-elaborate multipanel formats with several blisters, booklets, and inserts, says Ernie Bancroft, Eastern regional sales manager. The modular production platform allows rapid reconfiguration of the stations of the line, such as component feeding and panel-folding units. “It has so much flexibility and capability, our operations group can easily switch package formats for different products,” says Weiner. This is especially important to Cardinal Health, he says, “because the industry is going to smaller lot sizes.” He adds: “Speed is not the issue—changeover is, and the modular system will help us. We expect more uptime with this system, and therefore more throughput, because fewer adjustments are needed.”

Bancroft says that the NeoWallet 800 line can be converted to run a different format in 30 minutes by two operators without any tools. Weiner confirmed this at Pack Expo International 2004, when he and a technician from Körber Medipak changed the machine over on the show floor. “You download settings to different areas on the machine, and then you go around and adjust the machine until the digital readout is the same as the current position,” he explains.

Cardinal Health is adding additional capabilities to the unit. “We’ve added extra magazines for assembling multiple-blister wallets, as well as two literature feeders,” Weiner says. Two existing suites at the company’s Red Lion Rd. location will be converted into one in order to feed the machine from an existing thermoformer.

The NeoWallet is scheduled for a factory acceptance test in spring 2006. After installation and validation, the machine will begin producing wallets for jobs that are currently run on Cardinal Health’s existing heat-seal equipment.

Shifting from a heat-sealing walleting operation, Weiner has seen a lot of interest in glue-seal walleting systems. “Companies are concerned about the effect of heat on soft gels, for instance,” he says. Weiner isn’t worried about the switch affecting child resistance. “We expect the system to provide F=1 child-resistant packages.” For instance, in addition to being able to produce Cardinal Health proprietary wallet systems, it can produce Dividella’s ShiftPack for F=1 child resistance, and BoxWallet designs from Dividella.

When automating equipment, Luciano says that it is extremely important “to coordinate the efforts of machine engineering, tooling, and package design to produce a package that will feed appropriately and efficiently into the wallet card. The curl of the blister can be critical for feeding into the card.” In a hand-fed assembly, she advises careful handling of the blister foil unit. “The use of hard tempered foil or cold-form foil should be addressed. Hard tempered foil can be more sensitive to punctures in a hand-assembly operation. In addition, cold-form foil cavities may have a tendency to dent more frequently.”

Bahr of MGS Machine says that his firm’s experience has been that the package style has been determined by the time MGS is invited to participate. However, “I think we could add value as an equipment provider if we were asked to assist in helping determine the package style based on the customers’ overall requirements.” For instance, a better understanding of equipment options and levels of automation and production during packaging conception may lead companies to different designs and materials than originally expected.

Table II. Blister packaging by ASTM type, as catalogued by the Consumer Product Safety Commission at
www.cpsc.gov/BUSINFO/pppaguid/astmindex.html. The ASTM classifications are extracted, with permission, from D3475-05, Standard Classification of Child-Resistant Packages, copyright ASTM International, 100 Barr Harbor Dr., West Conshohocken, PA 19428-2959. Copies of the complete standard may be purchased from ASTM International (www.astm.org).
(click image to enlarge)

Deichert describes Bosch’s walleting process for the Pharma SHR as one in which two flat paperboard planks are automatically formed into inner and outer sleeves and ultrasonically welded in a 10-step process. Blisters or paperboard blisters can then be glued to the inner sleeve using double-sided adhesive, either taken from a tray of already formed blisters or fed from an in-line blister-forming machine.

Dividella Pharma Packaging Technology offers a modular approach to walleting. Various sizes and configurations of wallets and box wallets—the company’s specialty, which includes the NeoWallet and BoxWallet—can be produced automatically at speeds ranging from 80 to 300 wallets per minute. Format changes do not require any tools, and they can be accomplished within 30 minutes. The modular construction allows the addition of components such as feeders for blisters and booklets, bar code printers and readers, RFID tag applicators, inspection camera control, closing glue stations, and others. Cardinal Health is in the process of installing a NeoWallet 800 line from Dividella. For more details, see the sidebar on page 38. Also, Forest Laboratories used the NeoWallet 800 system to create the Namenda BoxWallet.

Additional inspection systems may also be needed. According to Dick Nelson, account executive for Sharp, “Most packaging lines for carded blisters are two-step processes: a primary blister filling and a secondary card loading and filling step. To be compliant, the two-step process needs to have verification processes built into the operation to ensure that the proper blister unit from the proper lot is placed into the card in the correct orientation. As cards need flat blisters, the selection of the proper thermoforming materials and blister design is critical.”

BOTTOM LINE

Because of its versatility, “the wallet pack will remain a vital and evolving packaging design that both the consumer and packaging and marketing professionals will rely upon,” says Carl Hart, account executive for Sharp.

Because wallets can hold an incredible amount of text and literature, some firms may use them for instructions in multiple languages. Bosch’s Deichert cautions against the “one-world pack,” however. “Some multinationals want a world package, but the regulatory requirements for multiple countries can vary considerably, like for the United States and Europe. For instance, to provide all the languages spoken in Belgium and Luxembourg, companies would have to print instructions in several languages for each.”

Still, the wallet-style blister package provides ample room to carry a lot of marketing information. Massicotte from Ropack says that package designers can use their “imagination” with a wallet-style package to achieve “great product differentiation.”

In the near future, look for “higher line speeds, more flexibility in the styles of the cards, more panels, larger folders, more and different inserts, security device options, and closing formats,” anticipates Bahr from MGS Machine.

 

 
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