Child resistant packaging (CRP) is required for a wide range of hazardous household products including over-the-counter (OTC) and prescription medication. This type of packaging is intended to serve as a last line of defense that provides a physical barrier to prevent children under the age of 5 years from accessing substances that can be harmful to them. Studies indicate that child-resistant packaging is difficult for adults to open and potentially leading to inadequate reclosure (intentionally or unintentionally), or the transfer of contents to non-CRP containers and pill boxes, entire circumvention of the child resistant mechanism, all of which can facilitate unintentional medication ingestion by young children. The overarching objective of this research was to design and develop a novel child-resistant mechanism for a reclosable container / closure packaging system (RCCPS) for medication that is both adult-friendly and child-resistant. This research postulated that differences in anthropometric hand data (children vs adults) could be leveraged to develop a child resistant mechanism that distinguishes between the capabilities of adults and young children to apply torque to a RCCPS for medication. Young children (3-5 years) were found to utilize fewer grip types (3: cylindrical, spherical, and pronated spherical) when interacting with cylindrical push and turn child resistant packaging when compared with grip types employed by adults over 18 (6: cylindrical, spherical, and pronated spherical, box, pulp, lateral). Utilizing this insight, a two-piece, inner cap / overcap packaging system (patent pending: U.S. application no. 16/421,631) was developed which shields specific portions of the hand from gripping the inner cap by restricting the exposed surface area of the same. Our hypothesis was that the functional surface area (area where the inner cap is exposed) could be “tuned”. One-hundred fifty participants were tested in this study including: 50 children (4-12 years), 50 adult males (18-67) and 50 adult females (18-78). The average peak torque achieved by children aged 4 (n= 9) was significantly (p<0.0001) lower (4.0177 lbs-inch +/- 1.17 lbs-inch) with our experimental design compared to the control (continuous thread medication bottle with screw cap, 7.40818 lbs-inch+/-1.17 lbs-inch). There was no evidence of a significant difference (p=0.9581) among senior adults (65+ years, n=11) when using the control (18.5375 lbs-inch+/- 1.17 lbs-inch) compared to senior adults (65+ years) using our design (13.5047 lbs-inch +/- 1.17 lbs-inch). Additionally, the amount of average peak torque 4-year-olds generated with the experimental design (4.0177 lbs-inch +/- 1.17 lbs-inch) was significantly lower (p<0.0001) than senior adults’ average peak torque (13.5047 lbs-inch +/- 1.17 lbs-inch) with the experimental design. As such, findings may have implications for the design of effective child-resistant and adult-friendly closures.
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