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An MIT-led research team has developed a drug capsule that could be used to administer oral doses of insulin, potentially replacing the injections that people with type 2 diabetes have to make daily.
The size of a blueberry, the capsule contains a small needle compressed insulin, which is injected once the capsule has reached the stomach. When tested on animals, the researchers showed that they could deliver enough insulin to lower blood sugar levels to levels comparable to those produced by injections made through the skin. They have also demonstrated that the device can be adapted to administer other protein drugs.
"We really hope that this new type of capsule will one day help diabetic patients and perhaps anyone in need of treatment that can now be given only by injection or infusion," says Robert Langer, professor of David H. Koch Institute, member of MIT. Koch Institute for Cancer Research and one of the leading authors of the study.
Giovanni Traverso, an badistant professor at Harvard Medical School's Brigham and Women's Hospital and a visiting scholar in the Department of Mechanical Engineering at MIT, where he begins teaching in 2019, is also the lead author of the study. The first author of the document, which appears in the February 7 issue of ScienceAlex Abramson, a graduate student at MIT. The research team also includes scientists from the pharmaceutical company Novo Nordisk.
Video credit: Diana Saville
Self-referral
Several years ago, Traverso, Langer and their colleagues developed a pill covered with many small needles that can be used to inject drugs into the lining of the stomach or small intestine. For the new capsule, the researchers changed the design to no longer use only one needle, which allowed them to avoid injecting drugs inside the body. stomach, where they would be broken down by stomach acids before they have an effect.
The tip of the needle is composed of lyophilized insulin, compressed to almost 100%, according to the same process used to form drug tablets. The needle shaft, which does not penetrate the wall of the stomach, is made of another biodegradable material.
In the capsule, the needle is attached to a compressed spring held in place by a sugar disc. When the capsule is swallowed, the water in the stomach dissolves the disc of sugar, releases the spring and injects the needle into the wall of the stomach.
The wall of the stomach does not have a pain receptor. The researchers therefore think that patients could not feel the injection. To make sure that the drug is injected into the stomach wall, the researchers designed their system so that, regardless of the position of the capsule in the stomach, this one can Orient it so that the needle is in contact with the lining of the stomach.
"As soon as you take it, you want the system to correct itself in order to be able to make contact with the fabric," explains Traverso.
The researchers drew their inspiration for the autonomous orientation function in a turtle known as the leopard tortoise. This turtle, which is found in Africa, has a shell with a high and steep dome, allowing it to stand up if it rolls on its back. The researchers used computer modeling to propose a variant of this form for their capsule, which allows it to reorient itself even in the dynamic environment of the stomach.
"What's important is that the needle is in contact with the tissue when it's injected," explains Abramson. "In addition, if a person was moving or the stomach was grumbling, the device would not move from its preferred orientation."
Once the tip of the needle is injected into the wall of the stomach, the insulin dissolves at a rate that can be controlled by the researchers during the preparation of the capsule. In this study, it took about an hour for all insulin to be completely released into the bloodstream.
Easier for patients
In tests on pigs, the researchers showed that they could successfully deliver up to 300 micrograms of insulin. More recently, they were able to increase the dose to 5 milligrams, which is comparable to the amount that a patient with type 2 diabetes should inject.
Once the capsule has released its contents, it can pbad harmlessly into the digestive system. The researchers found that the capsule, made of biodegradable polymers and stainless steels, had no adverse effects.
Maria José Alonso, a professor of biopharmaceutical and pharmaceutical technology at the University of Santiago de Compostela in Spain, describes the new capsule as a "radically new technology" that can benefit many patients.
"We're not talking about incremental improvements in insulin absorption, which most researchers in the field have done so far. It is by far the most realistic and most impactful breakthrough technology revealed so far for the administration of oral peptides, "says Alonso, who has not participated in the research.
The MIT team continues to work with Novo Nordisk to further develop the technology and optimize the capsule manufacturing process. They believe that this type of drug delivery could be useful for any protein drug that should normally be injected, such as immunosuppressive drugs used to treat rheumatoid arthritis or inflammatory bowel disease. This can also work for nucleic acids such as DNA and RNA.
"Our motivation is to make it easier for patients to take medication, especially those who need an injection," Traverso said. "The clbadic is insulin, but there are many others."
The research was funded by Novo Nordisk, the National Institutes of Health, a Senior Research Fellowship from the National Science Foundation, Brigham and Women's Hospital, a Viking Olaf Bjork Fellowship and the MIT Undergraduate Research Opportunities Program.
Ester Caffarel-Salvador, Minsoo Khang, David Dellal, David Silverstein, Yuan Gao, Morten Revsgaard Frederiksen, Andreas Vegge, Frantisek Hubalek, Jorrit Water, Anders Friderichsen, Johannes Fels, Rikke Kaae Kirk, Cody Cleveland and Joy Collins, Siddartha Tamang, Alison Hayward, Tomas Landh, Stephen Buckley, Niclas Roxhed and Ulrik Rahbek.
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