New Openings in Bottles and Closures

Drug firms are working with suppliers and talking with end-users in their search for convenient and safe bottle and closure solutions.

By David Vaczek, Senior Editor

Comar has applied its Helical Lock system to glass and plastic vials for maintaining seal integrity after sterilization.

Closures have not lacked for innovation as industry has pursued the elusive goal of developing convenient yet child-resistant (CR) closure and bottle solutions. Many consumers, however, remain frustrated with CR closures, though they have grown familiar with push-and-turn or squeeze-and-turn designs.

As an aging population becomes less tolerant of unfriendly packaging, some drug firms are talking with customers and working with suppliers to develop solutions that users can truly appreciate. Companies that want customers to have a positive experience with their product have not relied solely upon senior-friendly CR testing standards.

“There is a growing sensitivity among pharmaceutical companies that just meeting the Consumer Product Safety Commission (CPSC) protocol may not be enough to make their customers happy. A product isn’t necessarily friendly [when it meets the CPSC standard], particularly to those with arthritis or other physical challenges,” says William Shankland, vice president, business development, Rexam Closures and Containers (Evansville, ID). “Companies are focusing on the consumer experience and on minimizing inconvenience.”

Responding to consumer feedback, McNeil Consumer Healthcare developed the EZ-Open cap, a non-CR closure specifically targeted to customers with arthritis. The design on bottles of Tylenol Arthritis Pain (acetaminophen) extended-relief caplets features a fat cap with large serrations for gripping. McNeil also employs new push-and-turn style closures on other Tylenol Arthritis Pain SKUs. The EZ-Open and the push-and-turn designs have gained ease-of-use commendations from the Arthritis Foundation. Companies with a family of product in different sizes are allowed to put out one noncomplying non-CR package, providing that the SKU is not the most popular item in the group. The package must be labeled as intended for households without small children, according to the Poison Prevention Packaging Act.

“Companies have come out with non-CR packages that became their most popular item. In those cases, they have had to convert it to a CR package and make their non-CR package another size,” says an industry consultant.

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O-I (Owens Illinois; Toledo, OH) is another manufacturer that has sought feedback from the Arthritis Foundation, where packaging that shows significant improvements in accessibility and ease-of use is identified through a formal test protocol. “We have emphasized making our CR performance meet the needs of the arthritic community,” says Roger Smith, director of global technology and innovation for O-I Healthcare Packaging Inc.

“Senior panels can generally accomplish opening and reclosing senior-friendly bottles. [But] we try to go beyond the CPSC requirements, and we have learned a great deal more about how to make packages easy to open and resecure. We tend to target the Arthritis Foundation’s criteria, which puts more of an emphasis on mobility and joint testing and on redundancy of opening,” he says.

Companies may be digging deeper to find out what their customers want. But making closures that meet both senior-friendly and CR needs remains the ultimate challenge. “You are not designing only for seniors. Among the 100 million people with arthritis, many are younger people with rheumatoid arthritis, with children in the home,” Smith points out.

CPSC’s test protocol puts an emphasis on ensuring that CR designs remain functional in use, since consumers tend to reapply them incorrectly or intentionally leave them unassembled if frustrated with them. After packaging is opened by adults and appears to be resecured, it is then given to a panel of children. The number of children in excess of 10% who succeed in opening the package counts as failures to resecure by adults.

O-I’s 1-Clic vial and closure reversible packaging system gives consumers and pharmacists a choice in the type of closure they will use. Several major retail pharmacy chains have transferred to the 1-Clic for prescription drug vials, says Smith. The one-piece system—which earned an Arthritis Foundation ease-of-use commendation— features an audible click when locked in place. The child-resistant position requires a tab to be held down and turned. In non-CR mode, closure threads are screwed into container threads. “Pharmacies typically have to offer a CR package, unless the customer requests a non-CR package. They have to carry two closures. The 1-Clic provides a very crowded pharmacy with one fewer item to stock,” says Smith.

ONE-PIECE DESIGNS

Some of the new CR closure designs are appearing in one-piece cap-and-bottle systems that offer the advantage of lower cost versus two-piece solutions. One-piece systems use less resin, requiring less tooling and cap assembly costs. The success of one-piece systems has caused manufacturers of two-piece systems to drop their prices in some cases, say suppliers.

“As customers look to drive cost out of the value chain in the packaging of solid-dose products, they are evaluating alternatives to current two-piece child-resistant closures,” says Jerry Miles, director of marketing, Alcan Global Pharmaceutical Packaging, Plastics America (Montreal). Alcan has been working with Rexam’s North America Closure division to develop complete packaging systems using one-piece closure designs.

Comar Inc. (Buena, NJ) has improved its Helical-Lock push-and-turn CR senior-friendly closure. “The system functions the same as the original, but we have increased the performance, making it easier to put on and remove,” says David Mansera, technical operations manager.

O-I will release early this year a one-piece push-and turn spring-lock design, says Smith. “The distinct advantage of one-piece systems over two-piece systems is that one-piece systems are not dependent on the application torque to be effective. The general public has been indoctrinated into pushing and turning when they see a CR closure, so the spring-lock design will give the customer something they know,” Smith says. “Once educated on nontorque-dependent closures, such as squeeze-and-turn closures, or our 1-Clic, consumers will prefer to use them. They like the audible click you get with a squeeze-and-turn closure,” he adds.

Rexam has provided a low-torque solution in a one-piece system with its Squeeze-Lok Low Profile squeeze-and-turn closure, where locking can be seen, heard, and felt. In push-and-turn designs, it offers closures with a positive off-drive function that requires less force to engage the CR mechanism, says Shankland.

Bouchons MAC Closures Inc. (Waterloo, QC) offers an alternative to push-and-turn and squeeze-and-turn CR caps with its flip-top cap and containers. They have gained use with RX, OTC, and health and beauty products because of their ease of use and attractive design, says Stephanie Roux.

The senior-friendly CR snap-on caps open with an audible pop when squeezed on the side. They include the FTCR19100 24 mm for liquids, the FTCR 19000 38 mm for tablets, and the FICR MACpack 38 mm for small counts, traveling, and trial sizes. “All industries that use CR closures have been extremely receptive to our new line. The nutraceutical industry is starting to consider CR caps as a value-added solution. They have not wanted to consider push-and-turn caps because older customers find them harder to use,” Roux says.

While safety and convenience are key issues in bottles and closures, other imperatives are driving design. “Alcan Global Pharmaceutical Packaging as a whole has been looking at where we can support our customers in their efforts to thwart counterfeiting and ensure product authenticity. The key is to understand what the customer is hiring the package to do. Customers are hiring packaging for assistance in compliance, brand recognition, and product integrity,” Miles says.

CAPS WITH CHIPS

Rexam Closures is exploring using RFID tags and taggants for brand protection and anticounterfeiting. Working with Tagsys (Doylestown, PA), the company is developing child-resistance closures with stock RFID tags. “We are in the conceptual stage, putting together prototypes for testing by our clients,” says Shankland.

In the past year O-I has set up a lab to test alternatives for mechanically attaching tags to closures and containers and for embedding the chips into the caps and containers during molding. The company will run a pilot with a major pharmaceutical manufacturer in the first quarter, says Smith.

Tags can be made more tamper resistant when they are attached inside caps or are placed “in the melt stream of the parison” for incorporation into caps and containers. Misreads that occur with tags affixed to labels can also be minimized.

“When tags are placed in labels, if the labels are not oriented or are touching, reads are compromised. When we have been attaching or embedding the chips, we have found it makes them much more forgiving to orientation.”

And cap and container tagging allows packagers to maintain line speeds and addresses the accountability issues that arise when tags are precoded. “Most of our customers want to label and program the chip after the fill, so they don’t have to match the bottle to the appropriate chip number. When you are precoding, you have to get the right label to the right line, at the right time. With the chip embedded in the container, you avoid the need for an extra piece of equipment for orienting the labels, which slows in-line label coding. We precheck the chip to make sure it is activated before fill. The write antenna can be placed in an optimized position where it takes up virtually no space, and you can program the tag at normal line speeds,” says Smith.

INNOVATIONS

In bottle materials, companies report continuing interest in glass-replacement materials for vials. Alcan and O-I offer plastic alternatives such as COC (cyclic olefin copolymer).

Companies are also testing Aclon (PCTFE) as a layer in blow-molded containers. Aclon was launched this year by Honeywell Speciality Films (Morristown, NJ) as a clear, high-barrier material for use in multilayer containers. O-I has tested Aclon as a possible alternative layer material in its proprietary MLX injection blow molded containers. “We have tested incorporating Aclon as one of the material choices,” says Smith.

The Healthcare Packaging Group, a division of O. Berk Co./Kols Containers (Union, NJ), is offering thick-wall HDPE pharmaceutical rounds in three sizes for products requiring moisture and light protection. The containers are more than twice as thick as standard bottles, with a minimum wall thickness of 0.050 in., says Steven Nussbaum, director of marketing.

O. Berk’s Desiccant Basket fits into standard stock containers and resides completely within the bottle. The basket supports easy retrieval of a desiccant from drug packaging for products requiring reconstitution or for use with pills capsules and tablets. “The desiccant basket has been sold to a company that places a powder in a bottle and then the pharmacist or customer must add a liquid to the powder. Without the basket, the desiccant would sink to the bottom, where it would be difficult to remove or might be ingested by the patient,” says Nussbaum.

Talisman Technologies LLC (Plainview, NY) has developed a bottle cap closure that dispenses only one dose at a time. The One Dose Pill Dispenser provides what the company calls “unit dosing with a bottle.” When the bottle is turned upside down, a mechanism ensures that only a single pill (or dosage, which may be two pills) is dispensed. The closure can be added to existing bottles and containers or incorporated into new designs. According to Shaan Khan, founder and coCEO, the precise dosing is hygienic and eliminates the chance of contaminating the remaining doses. A push-in-and-up tab as well as a turn-upside-down-and-spin motion makes the design child resistant and senior friendly, says Khan. He reports that drug firms are launching tests of injection-molded prototypes.

As they listen more closely to their customers, manufacturers are working with suppliers to surmount design hurdles and devise custom solutions for cap and bottle systems. Comar has put its Helical Lock system to a new use in response to a customer’s problem with closure back-off when screw-thread vials are sterilized.

“In standard screw thread systems, the pressure that is applied to the liner is released in sterilization, and the seal integrity is jeopardized. We developed a Helical Lock closure system for glass or plastic vials that resolves this problem. We now think this solution will perhaps have wider application in the marketplace,” says Manera.

“We often work with pharmaceutical companies on specific design questions they have,” adds Tom Collins, Comar’s vice president, sales and marketing. “Companies today are more likely to say, ‘I’ve got this problem, can you tell me how to solve it,’ rather than say ‘do you have a closure that fits this requirement,’” he says.

 

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