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Originally Published January 1999

PHARMACEUTICAL

Finding a Child-Resistant Closure That Is Truly Senior Friendly

Packaging engineers are frustrated that closures that are child resistant also seem to be senior adult resistant. Such frustration has prompted closure makers to modify existing designs and to devise new ones.

by Daphne Allen, Editor

It's been nearly a year since the grace period ended for complying with the Consumer Product Safety Commission's (CPSC) testing protocol for determining whether closures are both child resistant and senior friendly. And yet, if you ask drug consumers, especially the elderly, whether they've experienced a welcome difference in the ease of opening child-resistant closures, they're likely to say no. In fact, a recent quip in the Los Angeles Times said that, thanks to a new arthritis drug recently approved by FDA, four out of five patients taking the drug can now remove the child-resistant closure from their old medication.

Such criticism, however, is hardly the result of inactivity on the part of closure manufacturers. In fact, several new child-resistant, senior-friendly closures have been introduced over the past year, and more are on the way. Some are updated versions of existing designs; others are new. And many manufacturers work with drug companies to collaborate on new designs. However, closure manufacturers say that drug companies are reluctant to adopt new designs because they fear that replacing familiar closures with new ones may scare away consumers. Makers also say that drug packagers aren't usually willing to pay for the innovative, yet more expensive designs.

But to make their packages easier for adults to open, experts says that drug manufacturers should experiment with these new designs. Before deciding on a purchase, drug packagers should obtain closure samples from manufacturers and test them informally with elder consumers.

COMPETING NEEDS

Finding the right closure isn't easy. "Elders lack finger-to-thumb strength, but you can't make closures too easy to open because children will be able to open them, too," says John Bitner, manager of package design and development for Searle Co. (Skokie, IL). "So you are caught in the middle." To make sure its closures can be opened by seniors, Searle tests the closures in-house in a unique way. "We put on a work glove and we tape down the thumb," says Bitner. "Our customers are elderly and arthritic, so we need to mimic how they will be accessing the packages. We even go to 80 year olds. But there just isn't enough of this type of testing going on in industry." He also points out drug packagers should remember that adults often reach for medicine in the dark when their eyesight is diminished, so they have trouble reading instructions, especially those that are white raised characters on a white background.

CPSC holds drug manufacturers responsible for making sure that their packaging passes the testing protocol. Nonetheless, many closure manufacturers test their designs before they market them. Weatherchem Corp. (Twinsburg, OH), the maker of the Top-Squeeze closure, has conducted a series of focus groups with a randomly selected sample of adults. These studies are somewhat similar to the CPSC protocol test, where each adult is asked to perform opening and closing of the package and comment on their experience with the package. "We found it is the best way to understand what type of graphical instructions, shape of the package, and opening force the end consumer would consider to be user friendly," says a statement from the firm. Many drug packagers do rely on the closure vendors to perform such testing.

However, Steve Carow, vice president of sales for Carow International (Crystal Lake, IL), recommends that drug packagers perform their own protocol testing using the finished and filled packages, even if the closure supplier has conducted testing and passed. "Closure makers can't control bottle selection, filling, and capping, and these all affect closure function."

INNOVATIONS AND CHALLENGES

Used for more than 25 years, push-and-turn closures are the most common type of closure for prescription and over-the-counter (OTC) drugs. "The public is used to push-and-turn closures," says Steve Croke of Pharmacy Logistics, the supply-chain management firm for Kerr—Friendly and Safe Packaging (Cleveland). Sanner of America (Cherry Hill, NJ) decided to adopt a push-and-turn mechanism for its new closure. To help senior adults operate the closure, it designed an opening tool that inserts into the top of the screw cap. According to David Mattingly, Sanner's national sales manager, "the tool requires less effort than the traditional push-and-turn process." Independent testing has shown that children are not able to use the tool themselves, because "they have to fit the grooves of the tool into the closure top just right, and they have to have the ability to hold it and turn it simultaneously."

Because of the public's familiarity with push-and-turn closures, Croke says his firm decided to develop a push-and-turn closure, but instead of using the conventional two-piece design, it came up with a one-piece design. "With a two-piece push-and-turn closure, it is hard to know when it is open. With this design, once you push and turn it, it pops up, providing visual and audible evidence."

One-piece designs are growing in popularity for another reason. "One of the primary drivers is to take the cost out of packaging," says Peter Martin, vice president of sales and marketing for Captive Plastics (Piscataway, NJ). "One-piece designs are lightweight, and you can use a high number of cavities during molding, driving costs down."

The most popular type of one-piece closure is the squeeze-and-turn design. "Concerns about adult ease-of-opening made us turn to the squeeze-and-turn closure," says Joe Molnar, healthcare industry manager for Owens-Brockway (Toledo, OH). "The design minimizes the force it takes to squeeze the cap and open it."

A challenge facing one-piece squeeze- and-turn closure makers and users is to find a child-resistant design that seals efficiently, says Jeff Minnette, vice president of marketing and new product development for Rexam Closures (Evansville, IN). For Listerine, Rexam recently adapted its Squeeze Lok closure for the mouthwash and developed a proprietary sealing technology. When conducting focus studies, Minnette found that older adults preferred the squeeze-and-turn closures to push-and-turn ones.

Another challenge facing drug packagers is ensuring that small closures, such as those under 24 mm, pass the protocol. According to Carow, "seniors can't grab the small closures. But size modification isn't the solution. You can't make the closures bigger, because a big closure on a small bottle doesn't work aesthetically," he says. Increasing bottle size doesn't seem to be an option, either. "Small sizes are marketed for a reason."

In addition to the push-and-turn and squeeze-and-turn closures, suppliers also offer other types, like the design that requires users to line up corresponding arrows on caps and bottles and lift the lid. But the problem with these designs, says one drug packager, is that consumers aren't patient enough to follow complicated instructions. "The line-up-the-arrow and lift just doesn't work. People often open these containers in dark rooms, and you can't use colored arrows because that would make it easier for children. You've got to have easy-to-understand and easy-to-access opening instructions."

Drug companies are reluctant to try new designs. Says Bitner: "Companies are hesitant to convert from something conventional because of the risk of product failure. But if you aren't willing to think creatively, it won't get done." He says that another problem is that "many companies aren't willing to put up the capital to get unique closures into the marketplace."

John Scuderi, vice president of sales and marketing for Van Blarcom Closures Inc. (Brooklyn, NY), agrees. "Industry wants something cognitive, such as a cap like a jigsaw puzzle that kids can't figure out, but industry doesn't necessarily want to pay the extra costs associated with complex designs." Van Blarcom markets free-flowing push-and-turn closures, but has also developed a number of designs that are still in prototypes. One has a built-in feature that turns green when closed properly. If it is closed improperly, the mechanism stays red, indicating the package is not child resistant.

ADD-ON FEATURES

Many closure suppliers are incorporating other features into their child-resistant closures, helping companies save steps in the packaging process and reducing the number of vendors. Sanner's closure features a hinged breakaway tab on the top of the lid that pops out when the child-resistant mechanism is activated through either pushing and turning or pulling down on the cap. The absence of the tab indicates that the bottle has been opened, so it provides tamper evidence. It also has a tear band at the base of the closure.The closure can be supplied with a built-in desiccant cartridge that can hold either 2 g of silica gel or 3 g of a molecular-sieve adsorbing material.

Several closures are designed to help consumers quickly identify bottle contents. Kerr—Friendly and Safe Packaging's child-resistant closure is supplied with a clear cap, enabling pharmacists and users to see directly into the bottle. Owens-Brockway's Ultra-Loc, a two-piece push-and-turn closure, can be printed in two colors, allowing drug makers to print logos, instructions, and other messages colorfully. In April, MAC Closures Inc. (Waterloo, PQ, Canada) will launch its MACduma child-resistant, senior-friendly closures, offered with debossed pictographs and available in sizes from 20 to 45 mm.

Suppliers have also found ways to incorporate compliance tools into closures. In 1994, Owens-Brockway introduced MedTime, a two-piece push-and-turn closure with an indexing mechanism. "Every time you reclose the bottle, the closure advances to the next time you need to take your dose," says Molnar. Rexam Closures has combined a flexible blister package with a rigid plastic device. "The child-resistant molded mechanism is almost like a compact," says Minnette. "It also acts as a display carton and a shipping device."

CONCLUSION

After years of dominating the market-place, push-and-turn closures are now joined by other designs. Some say these newer closures are the solution to meeting consumer needs as well as satisfying the testing protocol and lowering packaging costs. But others still have doubts and would like to see even more-creative alternatives. "I don't see any radical new thinking. Perhaps we need to throw everything out and start over," says one frustrated drug packager.

Apart from this drastic solution are others, such as trying some of the modified designs and awaiting the upcoming ones. Most importantly, says Bitner, drug companies shouldn't give up. "It is possible to find a closure for both groups." The most troublesome challenge facing drug packagers is that people take caps off and leave them off, he says. "My goal is to get people to put it back on. To get that to happen, you've got to make the closure so easy to use they won't even think about leaving it off."

Bottles and closures courtesy Kerr—Friendly and Safe Packaging, Rexam Closures, and Sanner of America. Photo by Roni Ramos.