Star Treatment
Can star-shaped drug delivery capsules be the solution for ultra-long acting delivery?
Ultra-long acting oral dosage forms have been a goal for the pharma industry for years given that fewer repeat doses would improve patient compliance. But the developmental hurdles are manifold – the system has to stay stable in a capsule form for years, rapidly deploy in the gastric cavity, achieve multi-day gastric residence, release the drug in a linear fashion, and then exit safely out of the gastrointestinal tract. Not easy.
But Researchers at MIT and Brigham and Women’s Hospital think they have mitigated these problems and developed a drug delivery system capable of safely residing in the stomach for two weeks. We asked Giovanni Traverso, senior author of the paper, and a gastroenterologist and biomedical engineer at Brigham and Women’s Hospital, to tell us more.
What are benefits of ultra-long release?
The development of a capsule capable of residing in the stomach safely and releasing drug continuously enables the dosing of drugs once a week, or potentially once a month, making it easier for patients to engage with their medication. Several studies have shown that when dosed once a week rather than once a day, patients are more likely to take their medication. Our new delivery system can help address the problem of medication non-adherence, which currently costs more than $100 billion annually in the US in avoidable hospitalizations.
How does your device work?
The capsule is star-shaped and made of poly-caprolactone which is a hydrophobic polymer which protects the drug from the acidic stomach environment, and allows for gradual release over the course of 14 days. The star shape enabled extended residence due its size and the mechanical properties of the star. We focused on a drug called ivermectin, which has been used to treat parasitic infection, but also has the benefit of being toxic to malaria-carrying mosquitos. Although the system is star-shaped it is placed in a capsule and therefore what the patient swallows is identical to other capsules.
What safety concerns did you face in development?
We take safety very seriously and there were two areas of concern: potential intestinal blockage and the drug being released all at once. Regarding intestinal blockage, we have developed a system composed of linkers in the star-shaped device that selectively dissolve in the small intestines – mitigating this risk. As for the risk of releasing the equivalent of several weeks’ worth of drug in one go, we designed the system to hold the drug in a solid polymer, which prevents this problem and also helps protect the drug from the acidic environment of the stomach.
You have co-founded a company to take the technology further…
That’s right – the other co-founders are Robert Langer and Amy Schulman. Lyndra will focus on ultra-long acting oral delivery systems. We are targeting therapeutic areas where improved compliance and pharmacokinetic benefits can help improve patient outcome, including neuropsychiatric diseases, heart disease, and renal disease – among others. We are also working on the scale-up problem and we plan to begin first-in-human testing in 2017.
- AM Bellinger et al., “Oral, ultra–long-lasting drug delivery: Application toward malaria elimination goals”, Sci Transl Med, 8, 365 (2016).
Over the course of my Biomedical Sciences degree it dawned on me that my goal of becoming a scientist didn’t quite mesh with my lack of affinity for lab work. Thinking on my decision to pursue biology rather than English at age 15 – despite an aptitude for the latter – I realized that science writing was a way to combine what I loved with what I was good at.
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