There’s a lot to be said for the delivery method of drugs and its impact on patient use. In fact, there have even been branding and advertising campaigns squarely focused on the color of the pills that the consumer takes. I’ve also led research looking at the size of tablets, as well as the shape and color and how they correspond with physiological effects such as swallowing difficulty¹.  So each parallel line of evidence converges on the same conclusion: Drug delivery methods have an impact on the marketability, patient uptake, word of mouth advertising, and therefore practical effect-to-target in the population.

For example, if a prescription is, in a simple example, a solid dosage tablet containing 150 mg of active drug and is intended to be taken once per day (q.d.), this is a total of 1,050 mg of drug product per week ingested. Half-life and metabolites aside, if a patient forgets or rejects taking the pill let’s say twice in a week because it’s too large, causes stomach upset, or any number of other reasons, now they have ingested 750 mg over 7 days; this is 71% of the intended dose of medication. These deviations from expected intake are not trivial. If a drug was vying for FDA approval and the dosages varied by 30%, they would never be approved. And yet this is the sort of patient-level effect that happens regularly because of skipped doses. The healthcare burden due to patients not taking their medications as prescribed is in the billions of dollars.

Novel Drug Delivery
The public’s attachment to smartphones has helped cue the industry in to drug delivery methods which are perceived as highly personalized as well as have a high level of form-factor. Various auto-injector pens represent some of the best that drug delivery concepts have offered the market. For a couple of examples, the NovoPen (Novo Nordisk) was designed and refined over a period of about a decade, to the point at which it helped lead the class of personalized drug delivery. Current iterations keep track of last dose volume and duration since administered. Feedback from focus groups and users has helped to improve the designs over the years, and feelings of attachment with the technologies has been particularly high, considering these are medical devices.

Another delivery modality is the thin-film delivery Zuplenz (ondansetron, Galena Biopharmaceuticals) which delivers drug therapy for post-chemo and radiotherapy nausea and vomiting by way of oral soluble film about the size of a postage stamp.

There are other modalities which have been tried and are in research and design phases. For example, Pfizer’s Exubera (rDNA-origin insulin) was a pulmonary delivery drug technology. It was released and subsequently pulled from the market because the patient and physician adoption of the complex inhalation device was low².

Needle-free injectors are also in various stages of design and use, with the ultimate hope being a painless delivery experience for the user. With any of the high-touch delivery methods, form factor which engages the user, rather than acting as a tacit barrier to treatment compliance, are the top goals for success.

Future Prognosis
Drug delivery has just begun to scratch the surface with what could be done to engage the patient in such a way as to enhance compliance and keep the treatment at the front-of-mind. Part of the benefit of these novel delivery technologies is that the patient recalls the positive user experience with the technology. There are several great examples which are innovative and market-paving and are currently the exemplars of innovation that the next generations of drug delivery endeavor to reproduce.

An interesting, if likely, future state will be when there are dozens to hundreds of novel competitive drug delivery modalities, which will again saturate the market with competitors for the consumers’ attention. One of my pieces of advice has lately been to consider a future point in time where an individual is on two or three drug therapies in patch, pen, or other nontraditional deliveries and develop a way to differentiate from the consumer’s perspective how all of these pieces fit into his or her healthcare maintenance portfolio; and also how to make them easy to use together seamlessly, rather than appearing to be vastly different and disparate products. Part of this design work should take into account co-morbidities so that diseases that ‘travel together’ can have treatments which appear coherent. 

References

1. Locwin, B. (2011). The effect of size, shape, and color on medication tolerability and acceptance. Tablets & Capsules.
2. Carlson, B. (2007). Ousting the ‘ouch factor’ in drug delivery. Biotechnology Healthcare, 4(6), 15-16.

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Ben Locwin
Healthcare Science Advisors

Ben Locwin, PhD, MBA, is an author of a wide variety of scientific articles for books and magazines, as well as an acclaimed speaker. He also provides advisement to many organizations and boards for a range of healthcare, clinical, and patient concerns.