Medical Device Link.

Originally Published PMPN February 2004

Blister Packaging

Daphne Allen

Unit-dose blister packaging continues to offer benefits to both patient and drug maker. By using carded blisters, for instance, drug makers can convey regimen instructions and marketing details intended to encourage brand loyalty. Patients get more product information than they might otherwise have gotten. They also get reminders regarding their regimen as well as a record of their compliance.

However, there are challenges to using blister packaging. They can be costly to manufacture. Child resistance must be balanced with senior friendliness. Physicians aren’t always aware of what regimens are in unit-dose blisters, so they may write prescriptions that do not match blister pack counts. As a result, some firms shy away from choosing blisters for more than just samples or starter packs.

Still, packaging experts as well as drug makers that have employed blisters for their own products extol the benefits. And contract packagers and suppliers of blister materials and machinery continue to find ways to drive costs out of the blister and address other challenges.

COMPLIANCE, CONVENIENCE 

“The drug industry is always looking for better ways to educate physicians and patients to achieve better compliance and persistence. The billboard space available on a carded blister or other unit dose packaging is an excellent method,” says Larry Blake, director of marketing for MeadWestvaco.

Howard Thau, president of Sonic Packaging (Westwood, NJ), says that blister packaging can serve as a reminder to patients to take prescribed doses. “If they don’t, they won’t get the full benefits of the product.”

Kevin Carter of Uhlmann Packaging (Towaco, NJ) sees a continuing trend in providing patient starter kits that include unit-dose blisters, informational booklets, and other tools for the patient. “It’s all about getting patients as much information about their regimen as possible,” he says. “There are marketing as well as compliance reasons for getting information to patients, but in the end, patients are better informed.” He adds that his firm is seeing the development of more wallet-style blister cards, which have added panels for providing more information. One such example of a patient starter kit is the Aricept Fight Back kit from Eisai Pharmaceuticals, described in the sidebar. 

In addition to starter kits and physician samples making regular appearances in blisters these days, some drug maintenance regimens are making their own move into blisters. 

Colbert Packaging Corp. (Lake Forest, IL) is anticipating such demand for 30-day blister packages. “We have a new design under way with Anderson Packaging that will cover 30-day regimens,” says Glenn Grosskopf. “We should have such a product available at the end of the second quarter.”

Thau says that he is seeing blister packaging being used as alternative-delivery regimen packs. “One of our customers is developing a seven-cavity perforated blister for an upcoming hormone-replacement cream product. The thick cream will be filled directly into the blister cavity, which users will dispense by removing the peel-back lid material. With four blisters of seven cavities placed into the final package, the consumer will have a complete month’s worth of product in a pre-measured, ready-to-use regimen pack.” 

Bill Armero is general manager for Caraustar Specialty Packaging Division’s Pine Brook, NJ, primary packaging facility. He says that he has seen more consumer products moving into blisters lately, and not always for compliance reasons. He points to a recent project in which the Adams division of Pfizer, now Cadbury Adams, selected a blister in a printed paperboard sleeve for its HALLS Fruit Breezers throat lozenges. Caraustar was the single-source supplier of the blisters and paperboard sleeves and trays. “Blister packaging protects the products and offers portability,” he says.

Such portability is contributing to demand for travel packs, says Dieter Feldberg, sales and marketing manager for Perlen Converting AG (Kennett Square, PA). He says blister packages in cardboard sleeves are now being used to provide 6–12 tablets in a travel package. “Convenience is driving interest,” he says.

TRIMMING COSTS

Despite such marketing, compliance, and convenience benefits, costs often stop some manufacturers from choosing blisters.
Feldberg says that is why Perlen developed Generex. “Coated with 25 g of PVdC, it has a moisture-vapor transmission rate in between that of mono PVC and our Perlalux Duplex film, which is coated with 40–60 g of PVdC,” he says. “Generex was originally intended for generic pharmaceutical companies, but lately we have had interest from other companies as well.”

Klöckner Pentaplast of America Inc. (Gordonsville, VA) has also driven costs out of high-barrier materials with its newest film, Pentapharm Aclar G03. The three-layer laminated film uses PVC, EVOH, and Aclar and is presented as a cost-effective alternative to foil-based materials. Kent Sides, business manager of pharmaceutical films, explains that the film was “developed to expand the protective properties of Aclar film in the marketplace for applications that require a clear thermoformable film. [It can be used] for products that require excellent moisture and oxygen barrier, as well as an attractive cost-to-barrier ratio.” 

Another way to drive costs out of blisters is to improve forming and sealing operations through the use of engineered materials. Feldberg says that Perlen’s highest-barrier product, Starflex, is PVC coated with two dispersions, one a thermoelast and the other 60, 90, or 120 g of PVdC. “Without the polyethylene, we are able to increase productivity, running the film faster through sealing operations and reducing the heat needed for sealing,” he says. “We have heard from users that it runs well.”

EVC Rigid Films’ new PVC/Aclar line of film specifications also exhibits improved operational efficiencies, says John Chatillon, EVC’s sales and marketing manager. “Historically, Aclar laminations have been known for their extensive curl during the thermoforming process due to the shrinkage of the web profile. In answer to this problem, EVC developed a PVC formulation that matches up well to the Aclar’s shrink characteristics and the result is a PVC/Aclar lamination that exhibits minimal to no curl,” Chatillon says. Because of the improved layflat of the web, EVC’s “spec runs efficiently at higher speeds.” He also notes that the dimensional stability of the lamination also improves the layflat of the finished blister, which “helps ensure that cartoning runs smoothly.”

Michiel van den Berg agrees that pharmaceutical drug manufacturers need cost-effective blister films. Van den Berg is director of global pharmaceutical packaging development for Tekni-Plex. To meet the market need for cost-effective blister packs, he says that Tekni-Plex has completed the installation of new calendar equipment for the production of mono PVC. “Mono PVC is one of the most economical blister films for pharmaceutical blister packs,” he says.

Even blister carding is witnessing a cost reduction. Paul Glintenkamp, director of pharmaceutical packaging for Packaging Insights, says that in addition to offering traditional heat sealing for blister card assembly, his firm offers adhesive and release liner sealing options. “These can be more economical, depending on the volume and the package design,” he says. (For more on his project using such an alternative, see the sidebar)

MGS Machine (Maple Grove, MN) has been providing blister card sealing and handling equipment since 1991. The firm has noticed interest in the low-cost alternatives to heat sealing blister cards that Glintenkamp uses. “It is expensive to apply coating to board,” says Kevin Kennedy, MGS’s senior regional sales manager. “We’ve been seeing the need for firms to save money, and hot-melt is one alternative.” He adds that major drug firms are using hot-melt systems when child resistance is not required. “However, some designs using hot melt are relying on other features for child resistance.”

MGS’s newest Blister Card system is fully servo driven, features toolless changeovers, and employs an on-line hot-melt extrusion unit from Nordson. Multiple blister magazines feed the system, which applies the adhesive, folds panels in up to four sequences, seals the card with a compression roller, and closes the cards with labels, hot melts, or tucks. “As long as you use quality materials, including high-quality glue, you can avoid some of the challenges with working with hot melt, like glue stringing,” he explains.

Other firms are upgrading machine functions. IWKA PacSystems, for instance, has just released its new BP series of BlisterPack machines, designed to provide pharmaceutical manufacturers with “enhanced convenience and ease of operation,” says a company press release. The BP series is completely driven by independent servos so that sealing times and feeding times can be adjusted without affecting the rest of the cycle. The machines can package up to 600 blisters per minute and are available in either intermittent- or continuous-motion models.

Uhlmann is trying to take costs and labor out of patient-kit assembly with its new Toploader. The system is designed to erect, fill, and inspect cartons with multiple items, including blister packages or cards, literature, coupons, or even other packages in a wide range of sizes. Able to handle cartons from 70 ¥ 50 ¥ 15 mm to 250 ¥ 210 ¥ 150 mm in size, changeover time to other packaging formats has been minimized. A variety of components, such as feed systems or control and monitoring units, are available. The Toploader can be connected to thermoformers via blister feeders. 

FRIENDLY RESISTANCE

Complaints that child-resistant packaging is hard to open continue to prompt suppliers of blister packaging materials to find more-friendly systems of child resistance. 

Blister board, for instance, has gotten tougher for children to breach, say suppliers. For instance, last fall International Paper (Memphis) introduced a tearproof fold-over board with up to five times the tear resistance of current fold-over boards on the market, says the firm. The extrusion-coated board is designed to seal to PVC, PVdC, PETG, and Aclar. “Use of Everest Safe-Pak board allows packaging designers much more flexibility in designing and producing packaging that meets the most stringent F1 child-resistance protocols as established by the Consumer Product Safety Commission,” says Anna Thomas, marketing manager, International Paper Bleached Board Business. 

In December, Colbert Packaging announced that its PharmaDial blister card achieved an F1 child-resistance rating. Grosskopf credits this partially to the firm’s BlisterGuard paperboard, which uses a cross-laminated film from Valéron Strength Films that features high tear resistance. Anderson Packaging comarkets the package.

PharmaDial incorporates a blister feature that users must rotate 90 degrees in order to access a dose. This feature, which the firm calls easy to grip, has fared well during senior testing. “The test is complete and a success—we received a 97% effective rating,” says Grosskopf. 
MeadWestvaco Healthcare Packaging has also just announced that its Shellpak has achieved an F1 rating. The system consists of a traditional blister package placed inside a child-resistant, senior-friendly injection-molded-plastic shell. “We now have three platforms that all meet F1 resistance: Shellpak, Surepak, and Dosepak.”

PLANNING FOR BAR CODING

While more-inexpensive materials and better child resistance may increase blister demand, FDA’s pending bar coding regulation is already driving it. Renard Jackson says that Cardinal Health geared up for such demand a while ago. Jackson is executive vice president, sales and business development, for Cardinal Health’s packaging services. “Unit-dose bar coding is big. We’ve already had requests from both OTC and prescription drug companies,” he says, “even though the regulation is not final.” Cardinal Health has outfitted several lines with bar code printers, with three printing Reduced Space Symbology (RSS).

So far, Cardinal Health has redesigned two existing packages to accommodate unit-dose bar codes. “We made the blister packages a bit larger, redoing all the tooling ourselves. Once we had the new label copy from our customers, we were able to make the blister format changes in about 60 days,” Jackson says.

Caraustar has also prepared for bar coding. “Bar coding hasn’t shown up yet, but we are ready,” says Armero. “We’ve installed a new Metronic UV printer from Griffin-Rutgers on one blister line. The printer provides some of the best grades for RSS. It looks almost like preprinted foil.” 

Despite these innovations, some experts say that there will always be those firms reluctant to switch to blisters. “For some, I think it all comes down to cost,” says Rick Sury, vice president of strategic partnerships for Alcan Packaging. “You can drive costs out through operating efficiencies, but if the volume is not there, you may not see the cost savings.”

For the drug manufacturer, the most cost-effective method of packaging is to ship the drug product in large bulk bottles, typically 1000 count, says Tekni-Plex’s van den Berg. “When wholesalers are repackagers and the pharmacy is also repackaging, [there is not] a clear case for prescription drug blister packs. However, any cost upcharges for a compliance blister pack are offset by the total cost of noncompliance, which is estimated at 13% of all healthcare expenditures.”

Michael Franklin, vice president of Tekni-Plex’s pharmaceutical packaging group, adds that future FDA packaging guidelines driven by the need for anticounterfeiting measures could cause a shift from bottles to blisters. Also, “Heightened consumer awareness of the need for compliance packaging could drive more user-friendly packaging that is easy, intuitive, and even fun to use, like Pfizer’s Z-Pak and TAP’s Prevacid NapraPAC,” he says.

Bottom line for Sury is this: “There is a cost to compliance packaging. Some accept the costs, because they know that if patients follow their regimens, they get better and stay better. They’re more likely to request that product again. Pharma companies can then benefit from a better mousetrap.” 

Copyright ©2004 Pharmaceutical & Medical Packaging News