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Volume 11, Issue 8
Pharmaceutical packaging designs evolve to protect children, while maximizing access for seniors.
The global market for child-resistant (CR) packaging is projected to grow 4% per year through 2023, according to a report from Market Research Future (1). In the United States, CR packaging requirements have been a fact of life since 1970, when Congress passed the Poison Prevention Packaging Act (PPPA) to protect children from accidental poisoning.
Over the years, the Consumer Product Safety Commission, the federal agency that crafts PPPA-related regulations, has expanded the list of products that must meet requirements for what the PPPA calls “special” packaging (CR and adult-friendly). Recent pharmaceutical additions include products containing imidazolines (2). Despite being required for nearly 50 years, CR packaging continues to evolve, and the expanding market for cannabis-based products has helped spur a new round of development efforts.
Nonetheless, missteps still occur. The absence of an effective CR feature is a frequent cause of recalls. At least three recalls involving products containing lidocaine have occurred since mid-2017: 56,000 4-oz jars of Synodrin Lidocaine Maximum Strength Pain Relieving Cream in November 2017 (3); 74,000 2-oz tubes of Well at Walgreens Pain and Itch Relief Cream in January 2018 (4); and 500,000 1-oz tubes of Maximum Strength Bacitraycin Plus Ointment with Lidocaine in March 2018 (5). At the time of the recalls, no injuries had been reported.
CR features can be incorporated in rigid or flexible packaging. Several sources supply flexible packaging with a CR zipper track and slider, including ProAmpac and Presto Products (2). For rigid packaging, the family of CR closures continues to expand. One recent addition is a 63 mm-diameter, wide-mouth closure from Mold-Rite Plastics (6).
But the highest level of activity appears to be occurring in CR “wallet” packs for blister cards. A major advantage of a CR wallet pack is increased print area for information or illustrations compared to similar size bottles. Wallet packs also can eliminate the need for CR blister structures, which typically require peeling away a paper layer before the dose can be pushed through the lidstock. This type of blister card can be difficult to open, especially for seniors.
One wallet upgrade that improves ease of opening for seniors, the Locked4Kids 2.0 pack, achieved a 100% first-try opening rate without any previous instruction to the testers. Before the redesign, only 93% of seniors could open the pack on the first try, reports Janet Schultze, director of Business Development at Locked4Kids. The patient or caregiver gains access to the blister card by pushing in smaller tabs to unlock “hooks” and pulling out the tray. Like its predecessor, a tear-resistant film laminate prevents children from accessing medication by biting or tearing the package. An end flap sealed with full adhesive coverage can’t be picked open, and a tab on the manufacturer’s joint tears before the pack opens. As a result, the Locked4Kids 2.0 pack has achieved an F=1 status, which is the strictest rating.
Four out of 11 patents on the Medlock EZ wallet design, developed by Colbert Packaging, cover CR features. The design can accommodate a calenderized blister and meets the requirements for an F=1 rating. The first commercial adoption of the Medlock wallet pack is vitaPearl Prenatal MultiVitamin with DHA [docosahexaenoic acid, a type of omega-3 fatty acid].
Another CR wallet with an F=1 rating, the EcoSlide-OTC pack from Keystone Folding Box, targets over-the-counter (OTC) products packaged in blisters. It relies on the same reclosable locking mechanism as its enhanced, easier-to-activate Ecoslide-RX 3.0 package for clinical trial material and commercial prescription products. True to its name, the Ecoslide-OTC pack consists of 100% recyclable paperboard and separates easily from the internal blister for recycling. The blister goes in the trash, but represents a significant source reduction compared to a bottle. “Millennials are continuously seeking attractive, alternative, eco-friendly packaging, while the growing senior population is looking for solutions that are easier to open. Ecoslide-OTC addresses all of these challenges,” explained Ward Smith, director of Marketing and Business Development at Keystone Folding Box, in a press release (7).
Machinery builders haven’t stood still either. To empty CR blister cards that need to be reworked, the laser-equipped RPB Bauer CP50 deblistering machine from Prodieco slices the lidstock around the perimeter of each pocket and then bends the card to eject the solid doses. The unit can empty up to 65 cards/min and offers an infinitely adjustable format range from 40 x 55 mm to 145 x 130 mm.
1. Market Research Future, “Global Child Resistance Packaging Market Is Predicted to Grow at Approximately 4% by 2023,” www.marketresearchfuture.com/press-release/child-resistance-packaging-market, accessed June 28, 2018.
2. H. Forcinio, “Child-Resistant Packaging Meets Regulations and Consumer Needs,” Pharmaceutical Technology Equipment and Processing Report (Nov. 19, 2014).
3. US Consumer Product Safety Commission, “Natural Solutions for Life Recalls Synodrin Pain Relieving Cream Due to Failure to Meet Child Resistant Closure Requirement,” Press Release, Nov. 30, 2017.
4. US Consumer Product Safety Commission, “Walgreens Pain and Itch Relief Cream Recalled by Natureplex Due to Failure to Meet Child Resistant Closure Requirement,” Press Release, Jan. 30, 2018.
5. US Consumer Product Safety Commission, “First Aid Research Recalls Maximum Strength Bacitraycin Plus Ointment with Lidocaine Due to Failure to Meet Child Resistant Closure Requirement,” Press Release, March 7, 2018.
6. PMMI Media Group, “Latest Child-Resistant-and Senior Friendly-Closures,” Email, Mar. 7, 2018.
7. Keystone Folding Box, “Keystone Folding Box Co. Launches Ecoslide-OTC: A Compact, Child-Resistant Paperboard Package for Medication in Blisters,” Press Release, Aug. 9, 2017.