Elderly adults represent a rapidly growing demographic, with the population of people ages 70 and older expected to double by 2050. With this shift comes many new demands on healthcare systems. Aging adults are also one of the fastest-growing segments of the healthcare market, due in large part to high utilization of medications: nearly 90% of older adults take at least one prescription medication. There are also high rates of polypharmacy in this population, with an estimated 44% of elderly patients taking five or more medications simultaneously.
Increased medication use also exposes patients to packaging that may be difficult to open, creating opportunities for frustration or non-compliance. If an older patient cannot easily open a bottle or blister pack of pills, medication adherence and treatment outcomes may be impacted. For drugmakers, supporting this population isn’t just about creating the right medications–it’s about ensuring formulations and packaging are also aligned with the needs of patients who use them. Incorporating these factors early in the development process is key to preventing delays and supporting successful product development.
Balancing child safety with adult accessibility
In today’s pharmaceutical packaging design, safety is as critical as ease of use. The prevalence of accidental exposures and ingestion of medications and household products among children led Congress to enact the Poison Prevention Packaging Act (PPPA) in 1970. This legislation requires certain potentially hazardous products, including prescription and over-the-counter drugs, to be in packaging that is “significantly difficult for children under 5 years of age to open within a reasonable time”.
While the PPPA contributed to a significant decline in accidental chemical ingestion among children, the new packaging parameters created challenges for seniors and people with disabilities. Revised guidelines in the 2000s and 2010s emphasized the need for safe yet accessible packaging, leading to the rise of child-resistant, senior-friendly (CRSF) packaging designs. Rather than relying solely on force-dependent mechanisms that can be difficult for adults with arthritis or hand weakness, many of today’s CRSF designs incorporate senior-friendly features such as pop tops or specialized zippers.
Certifying packaging as CRSF involves real-world usability testing with both children and older adults. In these studies, children under five are given a limited time to try to open the package, while adults between the ages of 50 and 70 must be able to open and properly resecure it within a set timeframe. Testing requirements generally specify that at least 85% of children must be unable to open the package, while at least 90% of adults must be able to successfully open and properly resecure it. Because achieving this balance can be challenging, studies are often iterative, with design teams adjusting features like blister strength or cap force until requirements are met. Once successful, manufacturers issue a General Certificate of Conformity to demonstrate compliance with 16 CFR 1700 and support regulatory submissions. However, delays in meeting these criteria can slow certification and potentially impact overall development timelines, making early planning critical.
How packaging and formulation decisions fit together
Packaging is often treated as a downstream consideration, addressed only after the formulation is finalized. In reality, early formulation decisions can directly determine whether a product will be usable, scalable, and compliant with CRSF requirements. Factors such as viscosity, flow properties, dose uniformity, and sensitivity to moisture or oxygen all influence packaging compatibility and user experience. For example, a dermal cream must balance spreadability with structural integrity, but if it is too viscous, it may be difficult to dispense from certain containers or to reclose securely. Similarly, tablet hardness, coating, or blister compatibility can impact both stability and accessibility. Addressing these variables early—through formulation screening, excipient selection, and packaging feasibility assessments—helps prevent downstream issues that can delay development or require costly redesigns.
This is where integrated CDMO expertise becomes particularly valuable. By bringing together formulation scientists, packaging engineers, and human factors specialists early in development, teams can evaluate how formulation attributes will translate into real-world use and regulatory compliance. Upfront risk assessments that account for potential failure points in manufacturing, packaging, and patient interaction enable more informed decisions on materials, delivery formats, and testing specifications. Experienced CDMOs can also leverage platform knowledge and prior CRSF experience to guide trade-offs between performance, manufacturability, and usability. When formulation and packaging are developed in parallel, rather than sequentially, companies are better positioned to deliver products that meet regulatory requirements, scale efficiently, and function reliably for patients from the outset.
Designing for success
Drug packaging design sits at the intersection of aesthetics, accessibility, and safety, impacting both regulatory success and patient use. Difficult packaging can compromise medication compliance, but failing to strike an appropriate CRSF balance can delay FDA submissions and, in turn, market entry. By considering packaging during early formulation stages and iteratively refining designs, drugmakers can ensure their final product is safe for children while accommodating patients and caregivers with arthritis, essential tremor, or other comorbidities.
Bora Pharmaceuticals offers integrated CDMO capabilities backed by deep expertise in formulation development, packaging, and beyond. Whether you’re developing a dermal cream, oral solid dosage product, or even a controlled substance, Bora’s team supports formulation, scale-up, and commercialization activities throughout the development process.