Bright Idea, Dim Design

A recent report from the Tufts Center for the Study of Drug Development estimated the cost of developing a new drug at $2.6 billion (1) – a figure that has more than doubled in the last decade. Yet despite the huge sums being spent on research and development, the pharmaceutical industry does not always develop products and dosage forms that are fit for purpose.

I have spent a large part of my career working at the interface between manufacturing and development, bringing new products to market, and I can honestly say that I learn more about product design from patients than from anyone else. There is no question that those working in the industry are involved and committed, but we need to do more to ensure medicines are designed to meet the needs of patients, not industry.

Firstly, it’s important to recognize the most obvious fact: patients, by definition, are not well. It’s amazing how often this fact is overlooked. As an example from my own life, my late father received medication for the treatment of two chronic conditions that require a strict regime of medication: Parkinson’s disease and Alzheimer’s disease. My father’s fine motor skills were poor but a number of the tablets prescribed were small and supplied in blister packs. Simply removing a tablet from the pack and taking it was a daily challenge and, judging by the number of escaped tablets found under the toaster in the kitchen, not always successful. Oral solid dosage forms like tablets or capsules are popular with patients and manufacturers alike, but in the case of my father – and many other patients like him – a different dosage form, such as a larger orally dispersible tablet, would increase medication compliance and make their lives easier.

Another example comes from a frustrated colleague who couldn’t understand why a member of the development team kept asking if the product was “compatible with pureed apple” at every development meeting. The reason behind the seemingly odd question was simple: the most common administration route for the target patients, many whom were elderly and suffered from swallowing difficulties, was co-administration with food. In such cases, a granule or powder formulation is far more appropriate or alternatively an oral suspension may work, depending on the compound characteristics.

If manufacturers do not meet the needs of patients, they will often take matters into their own hands. I never cease to be amazed by how far patients will go to overcome some of the design shortcomings in pharmaceutical products. Simple solutions include grinding tablets or opening capsules, which may inadvertently undo a lot of the good work done in development or even be dangerous in some cases. In another example, an elderly patient used to ask visitors to open her child-resistant pill bottle because it was too difficult for her to open. But she also asked them not to close the bottle. Her strategy was to leave the bottle – a month’s supply – open until empty. Bang goes the in-use stability study! If the food industry can supply artificial sweeteners in simple push dispensers, why is the technology not adopted more widely for pharmaceutical products? There are obvious challenges to overcome, such as child resistance, but the technical solutions are available if we are willing look.

We, as an industry, need to more carefully consider patient needs and start moving away from decision-making that is based solely on what is most convenient from a manufacturing or development perspective. And that’s a big challenge. A standard round bottle is great for production because it removes the need to control orientation, but a square bottle would be easier for patients to handle. I know that meeting patients’ needs is not always easy, but it’s our job as manufacturers to innovate and come up with solutions, even if that means investing in new technical systems or hiring new expertise.

The way forward for us as a manufacturing industry, and some of us are already on this journey, is to better understand the day-to-day reality for patients, but also for care-givers and medical professionals, and adapt our operations to the realities we find. No doubt there will be challenges and some of our strongly held beliefs and solutions will need to change, especially as we move towards more personalized medicines and away from the historically successful blockbuster model.

Good end-to-end product design can truly enhance the patient’s experience and compliance – and it can offer significant benefits for the developer. In fact, the right combination of drug, dosage form, device and packaging can be life changing for patients.

How do you know if you’ve got it right? Don’t second guess – ask the patient!