A collaborative effort between the Gates Foundation and researchers based in Boston four years ago has reaped dividends for mankind: A multi-dose capsule that has the potential to solve one of medicine’s greatest problems – delivering oral drugs over an extended period of time with just one dose.

Unique mechanism of action

The capsule, once swallowed, transforms into a star-shape that prevents it from being passed into the small intestine, but allows other food to pass. This mechanism allows the pill to release medicine slowly over the course of days. After doing its job, the pill will then break apart and be passed through the digestive tract without being absorbed.

While today’s extended-release pills have reduced the frequency of dosages, the time spent in the patient’s stomach remains unchanged. For extended release pills, current solutions are in the forms of dermal patches or subdermal implants.

Promising preliminary clinical trials

Although this transformative device has been tested on pigs, promising results published in Science Translational Medicine have paved the way for human trials next year.

Admitting the inherent challenge being the reason behind the lack of such a contraption, Dr. Andrew Bellinger says, “There’s a reason nobody’s ever been able to do this before. It was pretty challenging.”

Bellinger is the cofounder of Lyndra, that has licensed the capsule technology from the Massachusetts Institute of Technology and Brigham and Women’s Hospital, where he is a practicing cardiologist.

This invention is the latest effort at solving a major flaw in drug delivery. This flaw lies in the very way our stomachs are designed to work; the stomach clears its contents multiple times a day, and as such, patients must consume the medications a few times a day.

Eliminating forgetfulness and enhancing care

This pill not only solves the flaw in drug delivery, but also counters one of the biggest, understated issues – a strict adherence to medication schedules. A study has estimated that less than half the world’s patients under long-term medication display a vigilant attitude towards consuming their medications.

The reasons they give are as simple as human-based errors – pure forgetfulness or neglect – to social-based circumstances, such as being reluctant to take their medication because of the stigma of their illness. Some patients also report a mental avoidance issue: they simply do not wish to be reminded about their health issues.

Big pharmaceutical companies are increasingly pushing for greater adherence to drug schedules – they lose revenue, estimated to be worth billions worldwide per annum when patients do not fill, or refill, their prescriptions. However, they state that such efforts are for the greater good of the community, and they are right.

Not consuming their medications promptly has wider reaching ramifications. Patients’ conditions may, and will, not improve, and in some circumstance would even worsen.

Macro-wide implications include the facilitation of bacteria developing antibiotic resistance, to an increased spending on healthcare for the nation when they do not recover. The United States alone lose $300 billion to such reasons.

The unique pill is set for regulatory approval for human clinical trial tests, but before that, more pre-clinical trial testing first. The pre-trials in animals are necessary to establish that such a pill would not be harmful while it is in the stomach.

The researchers also plan to invest more research efforts towards finding if certain medications may be rendered less effective by protracted time in the stomach, even inside the protection of the capsule. MIMS

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