For biopharma companies, designing therapies with elderly patients in mind is no longer a nice-to-have — it’s a clear business imperative. As we all know, adults over 65 represent one of the fastest-growing demographics. By 2050, 12.2% of the global population will be aged 70 or older, almost doubling the current number (6.4% in 2022). Elderly Americans are also one of the fast-growing segments of the healthcare market based on high utilization of medications. Almost 89% take at least one prescription medicine and, within this cohort, there are high rates of polypharmacy (individuals regularly taking five or more prescription medications). This wealth of prescriptions translates to a lot of difficult packaging, presenting countless opportunities for frustration or even non-compliance.
There is a better way to go. By investing in age-appropriate formulations and packaging, companies can align their products with the needs of the patients who take them. This can improve user satisfaction and outcomes from clinical trials to commercial supply, thereby strengthening market access and maximizing the value the therapy can deliver.
Why packaging got harder: The origins of child-resistant packaging
Unlike many product designs, pharmaceutical packaging is not all about ease-of-use. Manufacturers are also trying to prevent children from accidental exposures, a major issue that led Congress to pass the Poison Prevention Packaging Act (PPPA) in 1970. This legislation requires child-resistant packaging for prescription medications as well as most over the counter (OTC) drugs, along with hazardous chemicals and cleaning products.
Once child-resistant packaging became standard in the early 1970s, the fatality rate from accidental chemical ingestion among children five and younger fell significantly. However, making containers more difficult for children also complicated usage for many seniors. By the late 2000s and early 2010s, packaging testing protocols (16 CFR 1700.20 in the U.S., and EN 14375 in Europe) increasingly emphasized the need for packaging to also be accessible to seniors. This need for a balanced solution led to the modern rise of child-resistant, senior-friendly (CRSF) packaging, building on the basic child-resistant closures (CRC) invented by Dr. Henri Breault. Over time, designs shifted from purely force-dependent mechanisms (push-and-turn) to senior-friendly solutions using mental ingenuity, such as blister packs, pop-top jars, and specialized zippers, and other packaging options that line the pharmacy shelves today.
Proving packaging compliance
Certifying a product’s packaging as child-resistant, senior-friendly (CRSF) often involves literally putting prototypes into the hands of children and older adults. In a typical study, groups of children under five years of age are given five minutes to try to open the package. This may occur with or without a demonstration. A separate panel of adults aged 50–70 also need to open and properly resecure the medication container or package within a fixed amount of time. To pass, at least 85% of children must fail, while 90% of adults succeed.
CRSF packaging studies are often run iteratively. The design teams tinker with the blister resistance or the force required to open a push-turn cap until a satisfactory balance of failure and success is met. Once the data are in hand, manufacturers generate a General Certificate of Conformity attesting that the packaging meets 16 CFR 1700 requirements, which can then be referenced as part of NDA or ANDA filings.
These parameters are interesting hoops to jump through and when all goes well, somewhat unremarkable in the scheme of drug development. But it’s not a given that packaging products will pass on the desired timeline. If the senior panel can’t reclose a cap within 60 seconds, the General Certificate of Conformity will be delayed, potentially stalling the final FDA submission. In drug development, time is money, so it’s important to plan for success the first time around.
Planning packaging upfront
Too often, packaging is treated as a downstream consideration or something to “solve” once the formulation is locked. In reality, the earliest formulation decisions can determine whether a product will ultimately be usable, scalable, and compliant with CRSF requirements.
In drug manufacturing, doing something better — or even just different — can come at a cost. However, with proper planning, customer-centric formulations can be implemented smoothly and predictably. The key is thinking ahead across the full continuum of manufacturing, packaging, and delivery. This starts with upfront risk assessments: What happens if something goes wrong? Where are the likely failure points? How would you detect them, and what safeguards are in place? By identifying these variables early, teams can define appropriate testing specifications and avoid costly late-stage redesigns.
Consider a dermal cream intended to soothe irritation — it needs to be thick enough for coverage yet fast-absorbing. Without early packaging input, that same formulation could prove difficult to dispense or reclose safely. Aligning formulation with packaging from the outset ensures both performance and usability. Ideally, contract manufacturers have experts in-house to bring the right cross-functional expertise to the table early on. This includes formulation scientists, packaging engineers, human factors specialists, and, ideally, pharmacists who understand real-world patient use. When these perspectives are integrated early, companies can deliver products that are not only effective, but intuitive, safe, and ready for the realities of the market.
Packaging shouldn’t be an afterthought
Difficult packaging comes with tangible consequences, including lower adherence, higher rates of adverse events, and diminished real-world effectiveness. It can also delay FDA submissions and ultimately, market entry. This is why companies should be thinking about and workshopping packaging from the early formulation stages of drug development, to ensure the end-product is easy and able to accommodate comorbidities such as arthritis and essential tremor (either for patients or elderly caregivers administering the treatment). Options include easy-open containers, blister packs vs. bottles, and unit-dose packaging in long-term care settings. All of these are important designs, as the very best drug in the world can’t deliver good clinical outcomes if patients are non-adherent.
Photo credit: hillwoman2, Getty Images
Helen Clark is Bora Pharmaceuticals‘ Head of Technical Development. Her career experience includes over a decade of work at GSK and now over five years with Bora, where she’s led the transfer and development of over 30 molecules.
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