Multi-dose capsule gets tested on humans for first time
Taking one or more pills every day can be a hassle, with many people either forgetting or just not bothering. There could soon be an alternative, however. An experimental system that packs a week's worth of timed-release doses into one capsule has shown promising results in its first clinical study.
Developed by scientists at MIT, along with colleagues at Brigham and Women's Hospital, the system was first announced in 2016 and is now being developed by spin-off company Lyndra Therapeutics.
To recap our previous explanation of how the technology works, it all starts with a star-shaped assembly that has six rigid polymer arms, each arm loaded with medication. Those arms are joined together by a biodegradable elastic core, which allows the arms to be folded inward. Once the arms are folded, the whole thing can be placed inside a standard gelatine capsule and swallowed.
Upon reaching the stomach, the gelatine dissolves, thus releasing the star and letting its arms open back up. In that configuration it's too large to pass out of the stomach, yet it's still unobtrusive enough that it doesn't produce a blockage.
For the next week (or longer, depending on how the star is made) its arms continuously release their pharmaceutical payload, which is absorbed through the stomach lining. By that point, the star's core has dissolved to the point that the arms break off and proceed into the digestive tract. They're small enough that they pass harmlessly through it, being excreted with the feces.
Previously the system had been tested on pigs, successfully delivering the malaria drug ivermectin to the animals in one study, and simultaneously delivering three antiretrovirals in another. Now, Lyndra has used it on humans for the first time.
In the recent clinical study, eight healthy test subjects each swallowed one of the capsules. Each capsule in turn contained a total of 50 mg of memantine hydrochloride (a drug used to treat Alzheimer's disease), representing a week's worth of daily 7-mg doses. After one week had passed, it was found that the medication had been metabolized by the participants' bodies in a fashion similar to daily-dose Namenda XR, which is a commercial version of memantine hydrochloride. Any side effects that occurred were generally quite mild.
"This clinical study shows that our once-weekly dosage form can safely reside in the stomach with predictable pharmacokinetics [movement of drugs within the body]," says Lyndra co-founder Giovanni Traverso, a gastroenterologist at Brigham and Women's Hospital. "This paves the way for studying the controlled, steady delivery of drugs for schizophrenia, Alzheimer's disease and many other diseases."
Source: Lyndra Therapeutics